Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednisone, Thalidomide in Patients With Previously Untreated Multiple Myeloma (FIRST)
November 7, 2019 updated by: Celgene
A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, and Thalidomide Given for 12 Six-week Cycles in Patients With Previously Untreated Multiple Myeloma Who Are Either 65 Years of Age or Older or Not Candidates for Stem Cell Transplantation.
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.
Study Overview
Status
Completed
Conditions
Detailed Description
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease [PD] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.
Study Type
Interventional
Enrollment (Actual)
1623
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bedford Park, Australia, 5042
- Flinders Medical Centre
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Geelong, Australia, 3220
- Geelong Hospital
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Gosford, Australia, 2250
- Gosford Hospital
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Herston, Australia, 4029
- Royal Brisbane and Women's Hospital
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Malvern, Australia, 3144
- Cabrini Hospital
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Parkville, Australia, 3050
- The Royal Melbourne Hospital
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Perth, Australia, 6000
- Royal Perth Hospital
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Southport, Australia, 4215
- Gold Coast Hospital
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St Leonards, Australia, 2065
- Royal North Shore Hospital
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Wentworthville, Australia, 2145
- Westmead Hospital
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Wodonga, Australia, 3690
- Border Medical Oncology
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Wollongong, Australia, 2500
- Wollongong Hospital
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Woolloongabba, Australia, 4102
- Princess Alexandra Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Victoria
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E. Melbourne, Victoria, Australia, 3002
- Peter MacCallum Cancer Centre Divsion of Haematology Medical Oncology
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Footscray, Victoria, Australia, 3011
- Western Hospital
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Frankston, Victoria, Australia, 3199
- Frankston Hospital
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Leoben, Austria, 8700
- Hospital Leoben
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Linz, Austria, 4010
- Hospital of Elisabethinen Linz
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Linz, Austria, 4010
- Hospital of Barmherzige Schwestern Linz
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Linz, Austria, 4021
- General Hospital Linz
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Salzburg, Austria, 5020
- MM-015. Salzburger Landkliniken, St. Johanns-Spital, Universitätsklinik fur Innere Medizin III
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St. Pölten, Austria, 3100
- Hospital St. Polten
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Vienna, Austria, 1020
- Hospital of the Barmherzigen Bruder Vienna
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Vienna, Austria, 1160
- MM-015.Wihelminenspital
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Vienna, Austria, A-1090
- MM-015. Medizinische Universität Wien
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Wels, Austria, 4600
- Hospital Wels
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Wiener Neustadt, Austria
- Hospital Wiener Neustadt
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Antwerpen, Belgium, 2069
- ZNA Stuivenberg Centrumziekenhuis
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Arlon, Belgium, 6700
- Les Cliniques du Sud Luxembourg
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Brugge, Belgium, 8000
- AZ St-Jan Brugge Oostende AV
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Brussel, Belgium, 1000
- Jules Bordet Institut
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Brussels, Belgium, 1070
- Hôpital Erasme
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Brussels, Belgium, 1090
- AZ-VUB
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Bruxelles, Belgium, 1200
- Cliniques Universitaires St-Luc
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Edegem, Belgium, 2650
- Universitair Ziekenhuis Antwerpen
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Gent, Belgium, 9000
- UZ Gent
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Hasselt, Belgium, 3500
- Virga Jesse Ziekenhuis
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Leuven, Belgium, 3000
- Universitair Ziekenhuis Leuven, Campus Gasthuisberg
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Roeselare, Belgium, 8800
- H. Hartziekenhuis Roeselare-Menen vzw campus Wilgenstraat
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Yvoir, Belgium, 5530
- Cliniques Universitaires UCL de Mont-Godine
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Quebec, Canada, G1R 2J6
- CHUQ - Hotel-Dieu de QuebecHematology - Oncology
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- University Of Calgary
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Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5L3
- British Columbia Cancer Agency
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New Westminster, British Columbia, Canada, V3M 1X4
- Royal Columbian Hospital
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Surrey, British Columbia, Canada, V3V 1Z2
- BC Cancer Agency - Fraser Valley Centre
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Vancouver, British Columbia, Canada, V5Z 1M9
- Leukemia/BMT Program of BCDiv of Hem, Vancouver Gen Hosp
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Victoria, British Columbia, Canada, V8R 6V5
- Vancouver Island Cancer Center
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New Brunswick
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Saint John, New Brunswick, Canada, E2L 3L6
- Saint John Regional Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H2Y9
- Queen Elizabeth II Health Sciences Center
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Juravinski Cancer Centre
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London, Ontario, Canada, N6A 4G5
- London Health Science Centre
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Ottawa, Ontario, Canada, K1H 8L6
- Ottawa Hospital
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Toronto, Ontario, Canada, M4N 3M5
- Odette Cancer Centre
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Hospital Charles LeMoyne
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Laval, Quebec, Canada, H7M 3L9
- Hôpital de la Cité-de-la-Santé
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Levis, Quebec, Canada, G5V 3Z1
- Hotel-Dieu de Levis
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Montreal, Quebec, Canada, H2W 1S6
- McGill University
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Montreal, Quebec, Canada, H3T 1E2
- Sir Mortimer B. Davis - Jewish Genl
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Montreal, Quebec, Canada, H1T 2M4
- Hospital Maisonneuve - Rosemont
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Montreal, Quebec, Canada, G4H 1C5
- Hôpital du Sacré-Coeur de Montréal
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Montreal, Quebec, Canada, H2L4M1
- CHUM- Hopital Notre-Dame
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Beijing, China, 100044
- Peking University People's Hospital
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Beijing, China, 100020
- Chaoyang Hospital
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Chengdu, China, 610041
- West China Hospital of Sichuan University
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Shanghai, China, 200025
- Ruijin Hospital Shanghai Jiaotong University
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Tianjin, China, 300041
- Blood Disease Hospital, Chinese Academy of Medical Science and Peking Union Medical College
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Albi, France, 81000
- Clinique Claude BernardOncologie
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Amiens, France, 80054
- CHU Sud
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Angers cedex 01, France, 49033
- CHRU Hopital du bocage
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Argenteuil, France, 95100
- CH Argenteuil Victor Dupouy
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Bayonne, France, 64109
- Centre Hospitalier de la Côte Basque
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Blois cedex, France, 41016
- Centre Hospitalier
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Bobigny Cedex, France, 93009
- Hôpital Avicenne
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Bordeaux, France, 33300
- Polyclinique Bordeaux Nord Aquitaine
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Bordeaux, France, 33076
- Institut Bergonie Centre Regional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
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Bourg en Bresse cedex, France, 01012
- Hôpital de Fleyriat
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Brest cedex, France, 29609
- Hopital Augustin Morvan
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Caen, France, 14033
- CHU
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Caen cedex 5, France, 14076
- Centre François Baclesse
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Cannes Cedex, France, 06401
- CH
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Cergy-Pontoise, France, 95303
- CH Rene Dubois
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Chalon/Saone Cedex, France, 71321
- Centre Hospitalier William Morey
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Clamart, France, 92141
- Hôpital Antoine Béclère
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Clamart Cedex, France, 92141
- Hopital dinstruction des armees Percy
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Clermont Ferrand, France, 63000
- CHU Estaing
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Colmar cedex, France, 68024
- CH Louis Pasteur
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Creteil, France, 94010
- Hôpital Henri Mondor
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Dijon, France, 21034
- CHRU Hopital du bocage
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Dunkerque, France, 59385
- Centre Hospitalier General
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Grenoble, France, 38034
- Institut Prive de Cancerologie
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Grenoble cedex 09, France, 38043
- CHRU
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La Roche -Sur-Yon cedex 9, France, 85925
- Centre Hospitalier departemental
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Le Chesnay Cedex, France, 78157
- CH
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Le Havre, France, 76000
- Hopital J MonodRhumato Nord
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Le Kremlin bicetre CDX, France, 942975
- Kremlin Bicêtre
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Le Mans, France, 72000
- Centre Jean Bernard
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Le Mans cedex, France, 72037
- Centre Hospitalier
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Lille, France, 59000
- GH de Institut Catholique St Vincent
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Lille cedex, France, 59037
- CHRU-Hopital Claude Huriez
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Limoges Cedex 1, France, 87042
- CH - Hôpital Dupuytren
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Lyon, France, 69008
- Centre Leon Berard
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Lyon, France, 69495
- Centre Hospitalier de Valence
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Lyon cedex, France, 69437
- CHU Hopital Edouard Herriot
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METZ cedex 3, France, 57085
- Hopital de Mercy
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Marseille Cedex 9, France, 13009
- Institut Paoli-Calmettes
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Montauban cedex, France, 82017
- Clinique Pont de chaume Oncologie et Radiotherapie
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Montpellier Cedex 5, France, 34295
- CHU Montpellier - Hôpital Lapeyronie
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Mulhouse, France, 68000
- Hôpital Emile Muller
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Nantes, France, 44035
- CHRU - Hôtel Dieu
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Nice cedex 1, France, 06050
- Centre Antoine Lacassagne Oncologie medicale et Hematologie
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Nice cedex 3, France, 06202
- Hopital de lArchet 1
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Orleans, France, 45000
- CH La Source
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Paris, France, 75010
- Hopital Saint Louis
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Paris, France, 75015
- Hôpital Necker
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Paris, France, 75571
- CHU Hôpital St-Antoine
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Paris Cedex 14, France, 75679
- Hopital Cochin
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Pessac, France, 33604
- CHRU - Hôpital du Haut Lévêque
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Poitiers cedex, France, 86021
- CU CHU Clemenceau
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Reims, France, 51100
- CHU Reims - Hôpital Maison Blanche
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Reims cedex, France, 51032
- Hopital R. Debre
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Rennes Cedex, France, 35033
- CHRU Hopital de Pontchaillou
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Rennes cedex 02, France, 35056
- CHRU Hopital sud Medecine Interne
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Rodez, France, 12027
- CHG Rodez
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Rouen cedex, France, 76038
- Centre Henri Becquerel
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Saint Cloud, France, 92210
- Centre René Huguenin
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St Priest en Jarez, France, 42270
- Institut de Cancérologie de Loire
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St-Brieuc cedex 1, France, 22027
- Centre Hospitalier Yves Le Foll
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Strasbourg, France, 67098
- CHRU Hôpital de Hautepierre
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Toulouse cedex 9, France, TSA 40031-31059
- CHRU Hopital Purpan
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Tours, France, 37044
- CHRU Hopital Trousseau
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Tours cedex, France, 37044
- CHRU Hôpital Bretonneau
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Vandoeuvre Cedex, France, 54511
- CHRU Hôpitaux de Brabois
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Vannes cedex, France, 56017
- CH P. Chubert
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Villejuif, France, 94805
- Institut Gustave Roussy
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Dresden, Germany, D-01307
- Medizinische Kinik und Poliklinik I
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Dusseldorf, Germany, 40225
- Universitaetsklinikum Dusseldorf Klinik fuer Haematologie
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Essen, Germany, 45122
- Universitatsklinikum Essen-
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Frankfurt am Main, Germany, 65929
- Staedtische Kliniken Frankfurt am Main Hochst
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Giessen, Germany, 35385
- Universitätsklinikum Gießen
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Greifswald, Germany, 17487
- Ernst-Moritz-Arndt-Universität Greifswald
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Hamburg, Germany, 20099
- Askepios Klinik St. Georg
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Jena, Germany, 07740
- Universitätsklinikum Jena
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Leipzig, Germany, 04103
- Medizinische Klinik und Poliklinik II
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Lübeck, Germany, 23538
- Universitätsklinikum Schleswig-Holstein
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Muenster, Germany, 48129
- Poliklinik A
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München, Germany, 81377
- Medizinische Klinik III Klinikum der Universität München-Großhadern
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München, Germany, 81377
- Klinikum der Johann-Wolfgang-Goethe-Universtat
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Rostock, Germany, 18057
- Medizinische Fakultät der Universität Rostock
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Stuttgart, Germany, D -70376
- Zentrum F. Innere Medizin II Robert- Bosch-Krankenhaus GmBH
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Tübingen, Germany, 72076
- Medizinische Klinik - Abteilung II
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Ulm, Germany, 89081
- Klinik fur Innere Medizin III
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Athens, Greece, 11528
- Alexandra Hospital, University of Athens
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Athens, Greece
- University of Athens
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Athens, Greece, 124
- Attiko Hospital of Athens
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Athens, Greece
- Evangelismos Hospital of Athens
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Piraeus, Greece, 18537
- Metaxa Hospital Peiraias
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Thessaloniki, Greece, 540 07
- Theagenio Anticancer Hospital of Thessaloniki
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Dublin, Ireland, 24
- Adelaide and Meath Hospital
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Dublin, Ireland, 7
- Mater Misercordiae Hospital
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Galway, Ireland, ST46QG
- University Hospital Galway
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Bologna, Italy, 40138
- Policlinico S. Orsola
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Catanzaro, Italy, 88100
- Oncologia Medica, Università della Magna Grecia
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Genova, Italy, 16132
- Clinica Ematologica, A.O.U. San Martino di Genova
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Lecce, Italy, 73100
- Ematologia ed Immunologia, Azienda Ospedaliera Vito Fazzi di Lecce
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Matera, Italy, 75100
- Unità Operativa di Oncoematologia, Ospedale di Matera
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Milano, Italy, 20141
- Istituto Europeo Di Oncologia - IEO
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Milano, Italy, 20132
- U.O. di Ematologia e Trapianto di Midollo Osseo
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Milano, Italy, 20141
- Presidio Ospedaliero A. Perrino
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Modena, Italy, 41100
- Policlinico di Modena
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Napoli, Italy, 80131
- Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
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Palermo, Italy, 90146
- Casa di Cura La Maddalena, Divisione di Ematologia
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Pavia 2, Italy, 27100
- Policlinico San Matteo Universita Di Pavia
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Piacenza, Italy, 29100
- Ospedale Civile
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Pisa, Italy, 56126
- A.O. Universitaria Ospedale S.Chiara Dip.Oncologia, Div. Ematologia
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Reggio Emilia, Italy, 42100
- Arcispedale Santa Maria Nuova
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Roma, Italy, 00144
- Istituto Nazionale Tumori Regina Elena, Struttura Complessa Ematologia ed Unita di Cellule Staminali
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Rome, Italy, 00161
- Azienda Policlinico Umberto I, Universita La Sapienzadi Roma
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Torino, Italy, 10126
- Ospedale Molinette
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Anyang, Korea, Republic of, 431-070
- Hallym University Sacred Heart Hospital
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Busan, Korea, Republic of, 614-735
- Inje University Busan Paik Hospital
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Daegu, Korea, Republic of, 705-718
- Daegu Catholic University Medical Center 3056-6
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Daejon, Korea, Republic of, 301-721
- Chungnam National University Hospital
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Gyeonggi-do, Korea, Republic of, 410-769
- National Cancer Center
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Hwasun-goon, Korea, Republic of, 519-803
- Hwasun Chonnam National University Hospital
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Incheon, Korea, Republic of, 405-760
- Gachon University Gil Hospital
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Jeonju, Korea, Republic of, 561-712
- Chonbuk National University Hospital 42
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Seongnam, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
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Seongsanno, Korea, Republic of, 120-752
- Severance Hospital
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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Seoul, Korea, Republic of, 158-710
- Ewha Womans University Mokdong Hospital
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Seoul, Korea, Republic of, 137-701
- The Catholic University of Korea Seoul - Saint Mary's Hospital
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Auckland, New Zealand, 1023
- Auckland City Hospital
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Christchurch, New Zealand, 8011
- Christchurch Hospital
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Newtown, New Zealand, 6021
- Wellington Hospital
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Braga, Portugal
- Hospital de São Marcos
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Coimbra, Portugal, 3000-075
- Hospitais da universidade de Coimbra
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Lisboa, Portugal, 1649-035
- Hospital de Santa Maria
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Lisboa, Portugal, 1099-023
- Instituto Português de Oncologia de Lisboa
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Porto, Portugal
- Hospital de Santo Antonio- Porto
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Porto, Portugal, 4200-072
- Instituto Português de Oncologia Porto
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Badalona (Barcelona), Spain, 8916
- Hospital Universitari Germans Trias i Pujol
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Barcelona, Spain, 08025
- Hospital de La Santa Creu i Sant Pau
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Barcelona, Spain, 08907
- Instituto Catalan de Oncologia-Hospital Duran
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Cordoba, Spain, 14004
- Hospital Reina Sofia
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Girona, Spain, 17007
- Hospital Univ. Josep Trueta
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Madrid, Spain, 28040
- Hospital Clínico San Carlos
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28041
- Hospital 12 de Octubre
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Murcia, Spain, 30008
- Hospital General Universitario Morales Messeguer
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Málaga, Spain, 29010
- Hospital Clínico Virgen de la Victoria
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Palma de Mallorca, Spain, 7198
- Hospital Son Llatzer
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Pamplona, Spain, 31008
- Clinica Universitaria de Navarra,
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Reus, Spain, 43201
- Hospital Sant Pau
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San Sebastian, Spain, 20014
- Hospital de Donosti
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Santander, Spain, 39008
- Hospital Universtario Marques de Valdecilla
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Santiago de Compostela, Spain, 15706
- Hospital Clínico Santiago de Compostela
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Valencia, Spain, 46010
- Hospital Clinico Universitario de Valencia
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Valencia, Spain, 46009
- Hosptial La Fe
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Zaragoza, Spain, 50009
- Hospital Clínico Universitario Lozano Blesa
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Zaragoza, Spain, 50009
- Hospital Miguel Servet
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Linkoping, Sweden, SE 581 85
- Linköping University Hospital
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Stockholm, Sweden, SE 17176
- Karolinska University HospitalSolna
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Stockholm, Sweden, SE- 11281
- St. Görans Hospital
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Stockholm, Sweden, SE-14186
- Karolinska University Hospital Huddinge
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Aarau, Switzerland, 5001
- Abteilung Onkologie Haematologie des Kantonsspitals Aarau
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Basel, Switzerland, 4031
- Universitätsspital Basel
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Berne, Switzerland, 3010
- Inselsspital Bern
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Chur, Switzerland, 7000
- Kantonsspital Graubünden
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Lausanne, Switzerland, 1011
- Centre hospitalier universitaire vaudois CHUV
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Münsterlingen (TG), Switzerland, 8596
- Kantonsspital Münsterlingen
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Winterthur, Switzerland, 8400
- Kantonsspital Winterthur
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Taichung City, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 11217
- Veteran General Hospital - Taipei
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Tapei, Taiwan, 10002
- National Taiwan University Hospital
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Bangor, United Kingdom, LL57 2PW
- Gwynedd Hospital
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Bath, United Kingdom, BA1 3NG
- Royal United Hospital
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Belfast Northern Ireland, United Kingdom, BT9 7AB
- Belfast City Hospital Haematology Department
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Birmingham West Midlands, United Kingdom, B15 2TH
- Birminghman QE
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Bournemouth Dorset, United Kingdom, BH7 7DW
- Royal Bournemouth Hosp
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Bristol, United Kingdom, BS2 8ED
- Bristol Haematology and Oncology centre
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Cambridge, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital
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Cardiff, United Kingdom, CF14 4XW
- University Hospital of Wales - Cardiff
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Glasgow, United Kingdom, G12 0YN
- The Beatson West of Scotland Centre
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London, United Kingdom, SE1 9RT
- Guy's and St Thomas' Hospital - London
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London, United Kingdom, EC1A 7BE
- Dept of Haematology St Bartholomews Hospital
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London, United Kingdom, W12 0HS
- Royal Free Hospital
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Oxford, United Kingdom, OX3 7LI
- Churchhill Hospital
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Plymouth Crownhill Devon, United Kingdom, PL6 8DH
- Derriford Hospital
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Sheffield, United Kingdom, S10 2JF
- Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust
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West Yorkshire, United Kingdom, WF1 4DG
- Pinderfields General Hospital
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Wolverhampton, United Kingdom, WV10 OPQ
- New Cross Hospital- Wolverhampton
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Alabama
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Birmingham, Alabama, United States, 35294
- University of AL Birmingham
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California
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Los Angeles, California, United States, 90048
- Cedar Sinai Medical Center Dept of Medicine
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San Francisco, California, United States, 94143
- University of California, San Francisco- California
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Stanford, California, United States, 94305
- Stanford University Stanford
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Florida
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Gainesville, Florida, United States, 32607
- Gainesville Heme Oncology Associates
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Jacksonville, Florida, United States, 32207
- Baptist Cancer Institute
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Orange Park, Florida, United States, 32073
- Integrated Community Oncology Network
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Saint Petersburg, Florida, United States, 33705
- Gulf Coast Oncology
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West Palm Beach, Florida, United States, 33401
- Palm Beach Cancer Institute, LLC
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Illinois
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Centralia, Illinois, United States, 62801
- Southern Illinois Hematology Oncology
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Chicago, Illinois, United States, 60612
- Rush University Medical Center
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Chicago, Illinois, United States, 60612
- John H Stroger Hospital of Cook County
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Chicago, Illinois, United States, 60611
- Orchard Healthcare Research, Inc.
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Harvey, Illinois, United States, 60426-3558
- Ingalls Cancer Institute
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Kansas
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Wichita, Kansas, United States, 67124
- Cancer Center of Kansas
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Maine
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Scarborough, Maine, United States, 04074
- Maine Center for Cancer Medicine Blood Disorders
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Maryland
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Bethesda, Maryland, United States, 20817
- Center for Cancer and Blood Disorders
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Montana
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Billings, Montana, United States, 59107
- Billings Clinic
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New York
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Lake Success, New York, United States, 11042
- Arena Oncology Associates, PC
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North Dakota
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Fargo, North Dakota, United States, 58103
- Dakota Cancer Institute
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center Research
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
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Oregon
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Portland, Oregon, United States, 97227
- Kaiser Permanente Northwest Oncology Hematology
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- St. Luke's Hospital and Health Network
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Tennessee
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Collierville, Tennessee, United States, 38017
- The Cancer Center
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Memphis, Tennessee, United States, 38104
- University of Tennessee Cancer Institute
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Texas
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Galveston, Texas, United States, 77555-0561
- University of Texas Medical Branch
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Washington
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Seattle, Washington, United States, 98104
- Swedish Cancer Institute
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must understand and voluntarily sign informed consent form
- Age ≥ 18 years at the time of signing consent
Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below:
- MM diagnostic criteria (all 3 required):
- Monoclonal plasma cells in the bone marrow ≥10% and/or presence of a biopsy-proven plasmacytoma
- Monoclonal protein present in the serum and/or urine
- Myeloma-related organ dysfunction (at least one of the following) [C] Calcium elevation in the blood (serum calcium >10.5 mg/dl or upper limit of normal) [R] Renal insufficiency (serum creatinine >2 mg/dl) [A] Anemia (hemoglobin <10 g/dl or 2 g < laboratory normal) [B] Lytic bone lesions or osteoporosis
AND have measurable disease by protein electrophoresis analyses as defined by the following:
- IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
- IgA multiple myeloma: Serum M-protein level ≥ 0.5 g/dl or urine M-protein level ≥ 200 mg/24 hours
- IgM multiple myeloma (IgM M-protein plus lytic bone disease documented by skeletal survey plain films): Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200mg/24hours
- IgD multiple myeloma: Serum M-protein level ≥ 0.05 g/dl or urine M-protein level ≥ 200 mg/24 hours
- Light chain multiple myeloma: Serum M-protein level ≥ 1.0 g/dl or urine M-protein level ≥ 200 mg/24 hours
AND are at least 65 years of age or older or, if younger than 65 years of age, are not candidates for stem cell transplantation because:
- The patient declines to undergo stem cell transplantation or
- Stem cell transplantation is not available to the patient due to cost or other reasons
- ECOG performance status of 0, 1, or 2
- Able to adhere to the study visit schedule and other protocol requirements
Females of child-bearing potential (FCBP)^2:
- Must agree to undergo two medically supervised pregnancy tests prior to starting study therapy with either Rd or MPT. The first pregnancy test will be performed within 10-14 days prior to the start of Rd or MPT and the second pregnancy test will be performed within 24 hours prior to the start of Rd or MPT. She must also agree to ongoing pregnancy testing during the course of the study and after the end of study therapy. This applies even if the patient practices complete and continued sexual abstinence.
- Must commit to either continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use and be able to comply with effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including during periods of dose interruptions), and for 28 days after discontinuation of study therapy.
Male Patients:
- Must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy.
- Must agree to not donate semen during study drug therapy and for a period after end of study drug therapy.
- Must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
All patients must:
- Have an understanding that the study drug could have a potential teratogenic risk.
- Agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy.
- Agree not to share study medication with another person. All FCBP and male patients must be counseled about pregnancy precautions and risks of fetal exposure.
Exclusion Criteria:
- Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [i.e., less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of randomization]).
- Any serious medical condition that places the patient at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, patient with unstable cardiac disease as defined by: Cardiac events such as MI within the past 6 months, NYHA heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; patients with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
- Pregnant or lactating females.
Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)
- Untransfused platelet count < 50,000 cells/µL (50 x 10^9/L)
- Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- Renal failure requiring hemodialysis or peritoneal dialysis.
Prior history of malignancies, other than multiple myeloma, unless the patient has been free of the disease for ≥ 3 years. Exceptions include the following:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histological finding of prostate cancer (TNM stage of T1a or T1b)
- Patients who are unable or unwilling to undergo antithrombotic therapy.
- Peripheral neuropathy of > grade 2 severity.
Known HIV positivity or active infectious hepatitis, type A, B, or C. Primary AL (immunoglobulin light chain) amyloidosis and myeloma complicated by amyloidosis.
- 1 A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification as myeloma if proven to be myeloma-related.
- 2 A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Lenalidomide / Dexamethasone until disease progression
Lenalidomide plus low-dose dexamethasone given until disease progression
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Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression
Other Names:
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Experimental: Lenalidomide / Dexamethasone for 18 cycles
Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles
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lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles. Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles
Other Names:
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Active Comparator: Melphalan, Prednisone, and Thalidomide (MPT) for 12 cycles
Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles
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Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
Time Frame: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
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PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG).
Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy.
Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
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From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
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Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
Time Frame: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
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PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG).
Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy.
Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's).
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From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
Time Frame: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
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Overall survival was defined as the time between randomization and death.
Participants, who died, regardless of the cause of death, were considered to have had an event.
All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact.
Participants who were still being treated were censored at the last available date the participant was known to be alive.
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From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
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Percentage of Participants With an Objective Response Based on IRAC Review
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review.
A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review.
A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
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Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
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Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Time Frame: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
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Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first.
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Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
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Time to First Response Based on the Review by the IRAC
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
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The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
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Kaplan Meier Estimates of Time to Treatment Failure (TTF)
Time Frame: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
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TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
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From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
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Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
Time Frame: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
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TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death.
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From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
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Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
Time Frame: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
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Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy.
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From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
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Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
Time Frame: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
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Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy.
Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy.
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From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
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Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
Time Frame: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review.
A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated.
Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories.
Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated.
Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories.
Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated.
Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories.
Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
Time Frame: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated.
Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories.
Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours.
If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
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Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL.
Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support.
Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support.
Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support.
Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
Time Frame: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
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The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support.
Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support.
Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms.
Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
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Change From Baseline in the EORTC QLQ-C30 Pain Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms.
Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms.
Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
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Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms.
Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms.
Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss.
Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Constipation Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation.
Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea.
Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
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Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients.
It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact).
The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties.
Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma.
EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image.
Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much').
Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s).
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma.
EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image.
Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much').
Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma.
EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image.
Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much').
Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
|
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma.
EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image.
Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much').
Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
Time Frame: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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EQ-5D is a self-administered questionnaire that assesses health-related quality of life.
The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3).
A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score.
EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status.
A positive change from baseline score indicates improvement in health status and better health state.
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Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
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Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations Per Year
Time Frame: Day 1 (randomization) up to last visit completed 25 July 2016
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HRU was defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient.
HRU Analysis may help in evaluating potential costs and budget impact of new treatments from a payer perspective.
The rate of inpatient hospitalizations per patient year was calculated as the total number of hospitalizations divided by the total number of patient-years followed in the study period.
Patient-years (PY) were calculated as the duration from baseline to last available HRQL assessment for each patient.
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Day 1 (randomization) up to last visit completed 25 July 2016
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Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
Time Frame: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug.
Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE.
A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event.
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From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
Time Frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation.
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Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
Time Frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
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Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
Time Frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
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Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
Time Frame: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale.
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Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
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Improvement of Infection Rate by Observing the Historical Data Compared to the Clinical Data Base
Time Frame: From randomization to 24 May 2013
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Improvement of infection rate by observing historical data compared to the data within clinical database as not analyzed.
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From randomization to 24 May 2013
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Benboubker L, Dimopoulos MA, Dispenzieri A, Catalano J, Belch AR, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis N, Banos A, Tiab M, Delforge M, Cavenagh J, Geraldes C, Lee JJ, Chen C, Oriol A, de la Rubia J, Qiu L, White DJ, Binder D, Anderson K, Fermand JP, Moreau P, Attal M, Knight R, Chen G, Van Oostendorp J, Jacques C, Ervin-Haynes A, Avet-Loiseau H, Hulin C, Facon T; FIRST Trial Team. Lenalidomide and dexamethasone in transplant-ineligible patients with myeloma. N Engl J Med. 2014 Sep 4;371(10):906-17. doi: 10.1056/NEJMoa1402551.
- Facon T, Dimopoulos MA, Dispenzieri A, Catalano JV, Belch A, Cavo M, Pinto A, Weisel K, Ludwig H, Bahlis NJ, Banos A, Tiab M, Delforge M, Cavenagh JD, Geraldes C, Lee JJ, Chen C, Oriol A, De La Rubia J, White D, Binder D, Lu J, Anderson KC, Moreau P, Attal M, Perrot A, Arnulf B, Qiu L, Roussel M, Boyle E, Manier S, Mohty M, Avet-Loiseau H, Leleu X, Ervin-Haynes A, Chen G, Houck V, Benboubker L, Hulin C. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 2018 Jan 18;131(3):301-310. doi: 10.1182/blood-2017-07-795047. Epub 2017 Nov 17.
- Dimopoulos MA, Cheung MC, Roussel M, Liu T, Gamberi B, Kolb B, Derigs HG, Eom H, Belhadj K, Lenain P, Van der Jagt R, Rigaudeau S, Dib M, Hall R, Jardel H, Jaccard A, Tosikyan A, Karlin L, Bensinger W, Schots R, Leupin N, Chen G, Marek J, Ervin-Haynes A, Facon T. Impact of renal impairment on outcomes with lenalidomide and dexamethasone treatment in the FIRST trial, a randomized, open-label phase 3 trial in transplant-ineligible patients with multiple myeloma. Haematologica. 2016 Mar;101(3):363-70. doi: 10.3324/haematol.2015.133629. Epub 2015 Dec 11.
- Hulin C, Belch A, Shustik C, Petrucci MT, Duhrsen U, Lu J, Song K, Rodon P, Pegourie B, Garderet L, Hunter H, Azais I, Eek R, Gisslinger H, Macro M, Dakhil S, Goncalves C, LeBlanc R, Romeril K, Royer B, Doyen C, Leleu X, Offner F, Leupin N, Houck V, Chen G, Ervin-Haynes A, Dimopoulos MA, Facon T. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial. J Clin Oncol. 2016 Oct 20;34(30):3609-3617. doi: 10.1200/JCO.2016.66.7295.
- Delforge M, Minuk L, Eisenmann JC, Arnulf B, Canepa L, Fragasso A, Leyvraz S, Langer C, Ezaydi Y, Vogl DT, Giraldo-Castellano P, Yoon SS, Zarnitsky C, Escoffre-Barbe M, Lemieux B, Song K, Bahlis NJ, Guo S, Monzini MS, Ervin-Haynes A, Houck V, Facon T. Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide. Haematologica. 2015 Jun;100(6):826-33. doi: 10.3324/haematol.2014.120121. Epub 2015 Mar 13.
- Vogl DT, Delforge M, Song K, Guo S, Gibson CJ, Ervin-Haynes A, Facon T. Long-term health-related quality of life in transplant-ineligible patients with newly diagnosed multiple myeloma receiving lenalidomide and dexamethasone. Leuk Lymphoma. 2018 Feb;59(2):398-405. doi: 10.1080/10428194.2017.1334125. Epub 2017 Jun 22.
- Dumontet C, Hulin C, Dimopoulos MA, Belch A, Dispenzieri A, Ludwig H, Rodon P, Van Droogenbroeck J, Qiu L, Cavo M, Van de Velde A, Lahuerta JJ, Allangba O, Lee JH, Boyle E, Perrot A, Moreau P, Manier S, Attal M, Roussel M, Mohty M, Mary JY, Civet A, Costa B, Tinel A, Gaston-Mathe Y, Facon T. A predictive model for risk of early grade >/= 3 infection in patients with multiple myeloma not eligible for transplant: analysis of the FIRST trial. Leukemia. 2018 Jun;32(6):1404-1413. doi: 10.1038/s41375-018-0133-x. Epub 2018 Apr 26.
- Ailawadhi S, Jacobus S, Sexton R, Stewart AK, Dispenzieri A, Hussein MA, Zonder JA, Crowley J, Hoering A, Barlogie B, Orlowski RZ, Rajkumar SV. Disease and outcome disparities in multiple myeloma: exploring the role of race/ethnicity in the Cooperative Group clinical trials. Blood Cancer J. 2018 Jul 6;8(7):67. doi: 10.1038/s41408-018-0102-7.
- Jain T, Sonbol MB, Firwana B, Kolla KR, Almader-Douglas D, Palmer J, Fonseca R. High-Dose Chemotherapy with Early Autologous Stem Cell Transplantation Compared to Standard Dose Chemotherapy or Delayed Transplantation in Patients with Newly Diagnosed Multiple Myeloma: A Systematic Review and Meta-Analysis. Biol Blood Marrow Transplant. 2019 Feb;25(2):239-247. doi: 10.1016/j.bbmt.2018.09.021. Epub 2018 Sep 20.
- Ailawadhi S, DerSarkissian M, Duh MS, Lafeuille MH, Posner G, Ralston S, Zagadailov E, Ba-Mancini A, Rifkin R. Cost Offsets in the Treatment Journeys of Patients With Relapsed/Refractory Multiple Myeloma. Clin Ther. 2019 Mar;41(3):477-493.e7. doi: 10.1016/j.clinthera.2019.01.009. Epub 2019 Feb 14.
- Pegourie B, Karlin L, Benboubker L, Orsini-Piocelle F, Tiab M, Auger-Quittet S, Rodon P, Royer B, Leleu X, Bareau B, Cliquennois M, Fuzibet JG, Voog E, Belhadj-Merzoug K, Decaux O, Rey P, Slama B, Leyronnas C, Zarnitsky C, Boyle E, Bosson JL, Pernod G; IFM Group. Apixaban for the prevention of thromboembolism in immunomodulatory-treated myeloma patients: Myelaxat, a phase 2 pilot study. Am J Hematol. 2019 Jun;94(6):635-640. doi: 10.1002/ajh.25459. Epub 2019 Apr 1.
- Bahlis NJ, Corso A, Mugge LO, Shen ZX, Desjardins P, Stoppa AM, Decaux O, de Revel T, Granell M, Marit G, Nahi H, Demuynck H, Huang SY, Basu S, Guthrie TH, Ervin-Haynes A, Marek J, Chen G, Facon T. Benefit of continuous treatment for responders with newly diagnosed multiple myeloma in the randomized FIRST trial. Leukemia. 2017 Nov;31(11):2435-2442. doi: 10.1038/leu.2017.111. Epub 2017 Apr 4.
- Lu J, Lee JH, Huang SY, Qiu L, Lee JJ, Liu T, Yoon SS, Kim K, Shen ZX, Eom HS, Chen WM, Min CK, Kim HJ, Lee JO, Kwak JY, Yiu W, Chen G, Ervin-Haynes A, Hulin C, Facon T. Continuous treatment with lenalidomide and low-dose dexamethasone in transplant-ineligible patients with newly diagnosed multiple myeloma in Asia: subanalysis of the FIRST trial. Br J Haematol. 2017 Mar;176(5):743-749. doi: 10.1111/bjh.14465. Epub 2017 Jan 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2008
Primary Completion (Actual)
July 14, 2016
Study Completion (Actual)
July 14, 2016
Study Registration Dates
First Submitted
June 2, 2008
First Submitted That Met QC Criteria
June 3, 2008
First Posted (Estimate)
June 4, 2008
Study Record Updates
Last Update Posted (Actual)
November 20, 2019
Last Update Submitted That Met QC Criteria
November 7, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Thalidomide
- Lenalidomide
- Prednisone
- Melphalan
Other Study ID Numbers
- CC-5013-MM-020
- 2007-004823-39 (EudraCT Number)
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Clinical Trials on Multiple Myeloma
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Lawson Health Research InstituteThe Ottawa Hospital; Hamilton Health Sciences Corporation; Dalhousie University; Niagara Health SystemActive, not recruitingMultiple Myeloma in Relapse | Multiple Myeloma With Failed Remission | Multiple Myeloma Stage I | Multiple Myeloma Progression | Multiple Myeloma Stage II | Multiple Myeloma Stage IIICanada
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National Cancer Institute (NCI)Active, not recruitingSmoldering Multiple Myeloma | Refractory Multiple Myeloma | DS Stage I Multiple Myeloma | DS Stage II Multiple Myeloma | DS Stage III Multiple MyelomaUnited States
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Fred Hutchinson Cancer Research Center/University...National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Mayo ClinicCompletedMultiple Myeloma | Stage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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National Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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City of Hope Medical CenterCompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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University of WashingtonNational Cancer Institute (NCI)TerminatedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)CompletedStage I Multiple Myeloma | Stage II Multiple Myeloma | Stage III Multiple Myeloma | Refractory Multiple MyelomaUnited States
Clinical Trials on Lenalidomide and low-dose dexamethasone
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King Faisal Specialist Hospital & Research CenterCompleted
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Anaveon AGTerminatedHematologic Diseases | Multiple Myeloma | Refractory Multiple Myeloma | Adult Disease | Relapsed CancerSpain, Germany, France, Denmark, Switzerland
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MedImmune LLCCompletedNon-alcoholic Fatty Liver Disease (NAFLD) | Non-alcoholic Steatohepatitis (NASH)United States, Puerto Rico
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National Health Research Institutes, TaiwanNational Taiwan University Hospital; China Medical University Hospital; Chang... and other collaboratorsNot yet recruitingPeripheral T-cell Lymphomas (PTCL)Taiwan
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Lucozade Ribena SuntoryKing's College LondonCompletedPostprandial PeriodUnited Kingdom
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
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Emory UniversityNational Cancer Institute (NCI)TerminatedPneumonia | Coronavirus Infection in 2019 (COVID-19) | Severe Acute Respiratory Syndrome (SARS) PneumoniaUnited States
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Universitätsklinikum Hamburg-EppendorfGemeinsamer Bundesausschuss (G-BA); Staburo GmbHRecruiting
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Beijing Northland Biotech. Co., Ltd.CompletedSafety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.InfarctionAcute Myocardial InfarctionChina
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Spectrum DynamicsBrigham and Women's Hospital; Cedars-Sinai Medical Center; Oregon Heart and Vascular...Completed