Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
2022年9月8日 更新者：Amgen
A Randomized, Multicenter, Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
The primary objective was to compare progression-free survival in adults with relapsed multiple myeloma who are receiving CRd vs participants receiving Rd in a randomized multicenter setting.
研究概览
详细说明
This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for adults with relapsed multiple myeloma.
Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd.
Randomization will be stratified by β2 microglobulin levels (< vs ≥ 2.5 mg/L), prior bortezomib (no vs yes), and prior lenalidomide (no vs yes).
Participants will receive the treatment determined by randomization in 28-day cycles until disease progression or unacceptable toxicity (whichever occurs first).
研究类型
介入性
注册 (实际的)
792
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Haifa、以色列、31096
- Rambam Medical Center
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Jerusalem、以色列、91120
- Hadassah Medical Center, Ein Kerem
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Nahariya、以色列、22100
- Western Gailee Hospital - Nahariya
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Petach Tikva、以色列、49100
- Rabin Medical Center
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Ramat Gan、以色列、52621
- The Chaim Sheba Medical Center
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Rehovot、以色列、76100
- Kaplan Medical Center
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Izhevsk、俄罗斯联邦、426039
- First Republican Clinical Hospital under the Ministry of Healthcare of the Republic of Udmurtia
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Moscow、俄罗斯联邦、115478
- Federal State Budgetary Scientific Institution: N.N. Blokhin Russian Cancer Research Center
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Moscow、俄罗斯联邦、125101
- Moscow State Medical Institution Municipal City Clinical Hospital n.a. S.P. Botkin
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Moscow、俄罗斯联邦、125167
- Federal State Budget Institution: Hematology Research Center under MoH
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St. Petersburg、俄罗斯联邦、191024
- FSBI: Russian Research Institute of Hematology and Blood Transfusion under the Ferderal Agency for M&B
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St. Petersburg、俄罗斯联邦、197022
- State Higher Educational Institution: St Petersburg State Medical University n.a.I.P Pavlov
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St. Petersburg、俄罗斯联邦、197101
- SHEI: First St. Petersburg State Medical University N.a.I.P Pavlov under MoH, Clinic of Bone Marrow Transplant
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St. Petersburg、俄罗斯联邦、197341
- Federal State Budget Institute: Federal Almalov Medical Research Centre under Ministry of Healthcare
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Komi Republic
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Syktyvkar、Komi Republic、俄罗斯联邦、167904
- State Medical Institution Komi Republican Oncological Center
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Pleven、保加利亚、5800
- University Multiprofile Hospital for Active Treatment, "Dr. Georgi Stranski"
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Plovdiv、保加利亚、4002
- University Multiprofile Hospital for Active Treatment "Sveti Georgi"
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Sofia、保加利亚、1606
- Military Medical Academy Multiprofile Hospital for Active Treatment
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Sofia、保加利亚、1756
- Specialized Hospital for Active Treatment of Hematological Diseases
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Varna、保加利亚、9010
- Multiprofile Hospital for Active Treatment "Sveta Marina"
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Alberta
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Calgary、Alberta、加拿大、T2N 4N2
- Tom Baker Cancer Centre
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Edmonton、Alberta、加拿大、T6G 1Z2
- University of Alberta, Cross Cancer Institute
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British Columbia
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Vancouver、British Columbia、加拿大、V5Z 1M9
- Vancouver General Hospital
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0V9
- Cancer Care Manitoba
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Newfoundland and Labrador
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St John's、Newfoundland and Labrador、加拿大、A1B 3V6
- General Hospital, Health Sciences Centre
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Ontario
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal、Quebec、加拿大、H3A 1A1
- McGill University Health Center, Royal Victoria Hospital
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Montreal、Quebec、加拿大、H3T 1E2
- Sir Mortimer B. Davis - Jewish General Hospital
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Budapest、匈牙利、H-1097
- St. Istvan and St. Laszlo Hospital of Budapest
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Debrecen、匈牙利、H-4032
- University of Debrecen, Medical and Health Science Center
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Gyor、匈牙利、H-9032
- Petz Aladar County Teaching Hospital
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Gyula、匈牙利、H-5700
- Bekes County Pandy Kalman Hospital
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Kaposvar、匈牙利、H-7400
- Kaposi Mór County Teaching Hospital
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Pecs、匈牙利、H-7624
- University of Pecs
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Szeged、匈牙利、H-6720
- University of Szeged, Albert Szent-Gyorgi Clinical Center
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Belgrade、塞尔维亚、11000
- Clinical Center of Serbia, Clinic of Hematology
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Belgrade、塞尔维亚、11000
- Clinical Hospital Center Bezanijska Kosa
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Belgrade、塞尔维亚、11000
- Military Medical Academy, Clinic of Hematology
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Nis、塞尔维亚、18 000
- Clinical Center Nis, Clinic of Hematology
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Novi Sad、塞尔维亚、21 000
- Clinical Center of Vojvodina, Clinic of Hematology
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Wien、奥地利、1090
- Medizinische Universität Wien
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Wien、奥地利、1171
- Wilhelminspital der Stadt Wien, Zentrum fur Onkologie und Hamatologie
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Athens、希腊、11528
- Alexandra Hospital
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Patras、希腊、26500
- University General Hospital of Patras
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Dusseldorf、德国、40225
- University of Dusseldorf
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Frankfurt am Main、德国、60488
- Krankenhaus Nordwest
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Hamburg、德国、20246
- University of Hamburg-Eppendorf
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Heidelberg、德国、69120
- Universität Heidelberg
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Koblenz、德国、56068
- Stiftungsklinikum Mittelrhein
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Munchen、德国、81377
- LMU Klinikum der Universität
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Munster、德国、48129
- Universitätsklinikum Münster
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Wurzburg、德国、97080
- Universitätsklinikum Würzburg
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Milano、意大利、20162
- Azienda Ospedallera Niguarda Ca Granda
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Novara、意大利、28100
- Azienda Ospedllero Maggiore della Carita
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Pisa、意大利、56216
- Azienda Ospedaliera Pisana Ospendale Santa Chiara - Main
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Roma、意大利、00144
- Ospedale S. Eugenio
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Torino、意大利、10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
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Brno、捷克语、625 00
- University Hospital Brno, Department of Internal Medicine - Hematooncology
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Hradec Kralove、捷克语、500 05
- University Hospital Hradec Kralove
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Olomouc、捷克语、775 20
- University Hospital Olomouc
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Praha 10、捷克语、100 34
- University Hospital Kralovske Vinohrady - Prague
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Praha 2、捷克语、128 08
- General University Hospital Prague
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Antwerpen、比利时、2060
- Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
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Brugge、比利时、8000
- AZ Sint-Jan AV
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Brussels、比利时、1090
- UZ Brussel
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Bruxelles、比利时、1000
- Institut Jules Bordet
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Bruxelles、比利时、1200
- Cliniques universitaires Saint-Luc
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Leuven、比利时、3000
- UZ Leuven
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Clamart、法国、92140
- Hospital Antoine Beclere
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Le Mans、法国、72000
- Clinique Victor Hugo - Centre Jean Bernard
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Lille、法国、59037
- Hôpital Claude Huriez
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Mulhouse、法国、68070
- CH de Mulhouse, Hopital Emile Muller
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Nantes、法国、44093
- CHU Nantes Hôtel Dieu
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Paris、法国、75012
- Hôpital Saint-Antoine
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Paris、法国、75015
- Groupe Hospitalier Necker - Enfants Malades
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Toulouse、法国、31100
- Cancer Institut Universitaire de Toulouse-Oncopole (iUCT)
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Vandoeuvre-Les-Nancy、法国、54511
- Hopitaux de Brabois
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Gdansk、波兰、80-952
- University Clinical Centre, Department of Hematologii Transplantologii
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Gorzow Wielkopolski、波兰、66-400
- Samodzielny Publ. Szp. Wojewodzki w Gorzow Wlkp.
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Katowice、波兰、40-027
- Independent Public Teaching Hospital of Medical University of Silesia in Katowice
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Lodz、波兰、93-510
- Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
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Suwalki、波兰、16-400
- Szpital Wojewwodzki im. dr Ludwika Rydygiera w Suwalkach
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Torun、波兰、87-100
- Nicolaus Copernicus Municipal Specialist Hospital
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Warszawa、波兰、02-781
- Maria Sklodowska-Curie Institute of Oncology
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Zamosc、波兰、22-400
- Zamojski Non-Public Hospital
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Goteborg、瑞典、SE-41345
- Sahlgrenska Universitetssjukhuset
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Stockholm、瑞典、SE-14186
- Karolinska Universitetsjukhuset i Huddinge
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Stockholm、瑞典、SE-17176
- Karolinska Universitetssjukhuset Solna, Hematologiskt Centrum
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Bucharest、罗马尼亚、022328
- Fundeni Clinical Institute, "Stefan Berceanu" Center for Hematology and Bone Marrow Transplantation
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Bucharest、罗马尼亚、030-171
- Coltea Clinical Hospital
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Bucharest、罗马尼亚、050098
- Bucharest University Emergency Hospital
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Iasi、罗马尼亚、700483
- Regional Institute of Iasi
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Arizona
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Scottsdale、Arizona、美国、85259
- Mayo Clinic
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California
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Burbank、California、美国、91505
- Providence St. Joseph Medical Center
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Santa Rosa、California、美国、94503
- St. Jude Hospital Yorba Linda dba; St. Joseph Heritage Healthcare
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Stanford、California、美国、94305
- Stanford University
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Colorado
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Denver、Colorado、美国、80218
- Colorado Blood Cancer Institute
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Florida
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Lecanto、Florida、美国、34461
- Cancer and Blood Disease Center
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Illinois
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Chicago、Illinois、美国、60612
- Rush University Medical Center
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Indiana
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Indianapolis、Indiana、美国、46202
- Indiana University Health Melvin and Bren Simon Cancer Center
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Kansas
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Kansas City、Kansas、美国、66160
- University of Kansas Cancer Center
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Michigan
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Ann Arbor、Michigan、美国、48109
- The University of Michigan - Comprehensive Cancer Center
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Minnesota
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Rochester、Minnesota、美国、55905
- Mayo Clinic
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New Jersey
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Hackensack、New Jersey、美国、07601
- John Theurer Cancer Center at Hackensack University Medical Center
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New York
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New York、New York、美国、10016
- Nyu Clinical Cancer Center
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New York、New York、美国、10021
- Weill Cornell Medical College
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Tennessee
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Chattanooga、Tennessee、美国、37404
- Associates in Oncology and Hematology
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Texas
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Amarillo、Texas、美国、79106
- The Don & Sybil Harrington Cancer Center
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Dallas、Texas、美国、75246
- Baylor Sammons Cancer Center
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Dallas、Texas、美国、75390-8565
- UT Southwestern Medical Center at Dallas
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Houston、Texas、美国、77030
- The University of Texas, MD Anderson Cancer Center
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Temple、Texas、美国、76508
- Scott and White Memorial Hospital
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Washington
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Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research Center
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Wisconsin
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Milwaukee、Wisconsin、美国、53226
- Froedtert & Medical College of Wisconsin
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London、英国、SW17 0QT
- St. Georges Hospital
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London、英国、EC1A 7BE
- St. Bartholomew's Hospital
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London、英国、NW3 2QG
- Royal Free Hampstead
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Nottingham、英国、NG5 1PB
- Nottingham University Hospitals (City Campus)
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Sutton、英国、SM2 5PT
- Royal Marsden Hospital
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Wolverhampton、英国、WV10 OQP
- The Royal Wolverhampton Hospital NHS Trust
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Rotterdam、荷兰、3015 CE
- Erasmus MC, Department of Haematology
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Badalona、西班牙、08916
- Hospital Universitario Germans Trias i Pujol
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Barcelona、西班牙、08036
- Hospital Clinic I Provincial
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Salamanca、西班牙、37007
- Hospital Universitario De Salamanca
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San Sebastian、西班牙、20014
- Hospital Donostia
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Valencia、西班牙、46026
- Hospital Universitario y Politeecnico La Fe
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Zaragoza、西班牙、50009
- Hospital Universitario Miguel Servet
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Symptomatic multiple myeloma
Measurable disease, as defined by one or more of the following (assessed within 21 days prior to randomization):
- Serum M-protein ≥ 0.5 g/dL
- Urine Bence-Jones protein ≥ 200 mg/24 hours
- For immunoglobulin A (IgA) patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (0.75 g/dL)
- Prior treatment with at least one, but no more than three, regimens for multiple myeloma
- Documented relapse or progressive disease on or after any regimen
- Achieved a response to at least one prior regimen
- Age ≥ 18 years
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate hepatic function, with serum alanine aminotransferase (ALT) ≤ 3.5 times the upper limit of normal and serum direct bilirubin ≤ 2 mg/dL (34 µmol/L) within 21 days prior to randomization
- Absolute neutrophil count ≥ 1.0 × 10^9/L within 21 days prior to randomization
- Hemoglobin ≥ 8 g/dL (80 g/L) within 21 days prior to randomization
- Platelet count ≥ 50 × 10^9/L (≥ 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
- Creatinine clearance (CrCl) ≥ 50 mL/minute within 21 days prior to randomization
- Written informed consent in accordance with federal, local, and institutional guidelines
- Females of childbearing potential must agree to ongoing pregnancy testing and to practice contraception
- Male subjects must agree to practice contraception
Exclusion Criteria:
- If previously treated with bortezomib (alone or in combination), progression during treatment
If previously treated with a lenalidomide and dexamethasone (len/dex) combination:
- Progression during the first 3 months of initiating treatment
- Any progression during treatment if the len/dex combination was the subject's most recent line of therapy
- Discontinuation of previous lenalidomide or dexamethasone due to intolerance; subjects intolerant to bortezomib are not excluded
- Prior carfilzomib treatment
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- Waldenström's macroglobulinemia or IgM myeloma
- Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
- Chemotherapy or investigational agent within 3 weeks prior to randomization or antibody therapy within 6 weeks prior to randomization
- Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
- Corticosteroid therapy at a dose equivalent to dexamethasone > 4 mg/day within 21 days prior to randomization
- Pregnant or lactating females
- Major surgery within 21 days prior to randomization
- Acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomization
- Known human immunodeficiency virus infection
- Active hepatitis B or C infection
- Myocardial infarction within 4 months prior to randomization, New York Hear Association (NYHA) Class III or IV heart failure, uncontrolled angina, history of severe coronary artery disease, severe uncontrolled ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless subject has a pacemaker
- Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to randomization
- Other malignancy, including myelodysplastic syndromes (MDS), within the past 3 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or breast; c) prostate cancer of Gleason Grade 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder or benign tumors of the adrenal or pancreas
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) within 14 days prior to randomization
- Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib)
- Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to all anticoagulation and antiplatelet options, antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment
- Ongoing graft-vs-host disease
- Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization
- Any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Lenalidomide and Dexamethasone (Rd)
Treatment was administered in cycles repeated every 28 days.
Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22.
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第 1-21 天口服 25 毫克
其他名称：
40 mg orally or IV on days 1, 8, 15, 22
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实验性的：Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Treatment was administered in cycles every 28 days.
Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, escalating to 27 mg/m² on days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16.
Lenalidomide 25 mg was administered orally on days 1 to 21 from cycle 1 through cycle 18 and from cycle 19 and higher.
Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 from cycle 1 through cycle 18 and from cycle 19 and higher.
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第 1-21 天口服 25 毫克
其他名称：
40 mg orally or IV on days 1, 8, 15, 22
20 mg/m², 27 mg/m² intravenously
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Progression-free Survival (PFS)
大体时间：From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
|
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death.
PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC).
One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions).
Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
|
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Survival
大体时间：From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
|
Overall survival (OS) was defined as the duration from randomization to death due to any cause.
Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
|
From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.
|
|
Overall Response Rate
大体时间：From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
|
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome.
Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
|
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
|
|
Disease Control Rate
大体时间：From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
|
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
|
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
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|
Duration of Response
大体时间：From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
|
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR).
Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause.
Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
|
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.
|
|
Duration of Disease Control
大体时间：From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
|
Duration of disease control (DDC) was calculated for participants who achieved disease control.
DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause.
Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
|
From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.
|
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Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
大体时间：Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
|
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients.
Scores range from 0 to 100, with higher scores indicating better health related quality of life.
|
Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Dimopoulos M, Wang M, Maisnar V, Minarik J, Bensinger W, Mateos MV, Obreja M, Blaedel J, Moreau P. Response and progression-free survival according to planned treatment duration in patients with relapsed multiple myeloma treated with carfilzomib, lenalidomide, and dexamethasone (KRd) versus lenalidomide and dexamethasone (Rd) in the phase III ASPIRE study. J Hematol Oncol. 2018 Apr 4;11(1):49. doi: 10.1186/s13045-018-0583-7.
- Avet-Loiseau H, Fonseca R, Siegel D, Dimopoulos MA, Spicka I, Masszi T, Hajek R, Rosinol L, Goranova-Marinova V, Mihaylov G, Maisnar V, Mateos MV, Wang M, Niesvizky R, Oriol A, Jakubowiak A, Minarik J, Palumbo A, Bensinger W, Kukreti V, Ben-Yehuda D, Stewart AK, Obreja M, Moreau P. Carfilzomib significantly improves the progression-free survival of high-risk patients in multiple myeloma. Blood. 2016 Sep 1;128(9):1174-80. doi: 10.1182/blood-2016-03-707596. Epub 2016 Jul 20.
- Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Ro S, Aggarwal S, Moreau P, Palumbo A. Carfilzomib-lenalidomide-dexamethasone vs lenalidomide-dexamethasone in relapsed multiple myeloma by previous treatment. Blood Cancer J. 2017 Apr 21;7(4):e554. doi: 10.1038/bcj.2017.31.
- Dimopoulos MA, Stewart AK, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel D, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak A, San-Miguel J, Ludwig H, Palumbo A, Obreja M, Aggarwal S, Moreau P. Carfilzomib, lenalidomide, and dexamethasone in patients with relapsed multiple myeloma categorised by age: secondary analysis from the phase 3 ASPIRE study. Br J Haematol. 2017 May;177(3):404-413. doi: 10.1111/bjh.14549. Epub 2017 Feb 17.
- Jakubowiak AJ, Campioni M, Benedict A, Houisse I, Tichy E, Giannopoulou A, Aggarwal SK, Barber BL, Panjabi S. Cost-effectiveness of adding carfilzomib to lenalidomide and dexamethasone in relapsed multiple myeloma from a US perspective. J Med Econ. 2016 Nov;19(11):1061-1074. doi: 10.1080/13696998.2016.1194278. Epub 2016 Jun 16.
- Stewart AK, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Buchanan J, Cocks K, Yang X, Xing B, Zojwalla N, Tonda M, Moreau P, Palumbo A. Health-Related Quality-of-Life Results From the Open-Label, Randomized, Phase III ASPIRE Trial Evaluating Carfilzomib, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With Relapsed Multiple Myeloma. J Clin Oncol. 2016 Nov 10;34(32):3921-3930. doi: 10.1200/JCO.2016.66.9648.
- Chari A, Stewart AK, Russell SD, Moreau P, Herrmann J, Banchs J, Hajek R, Groarke J, Lyon AR, Batty GN, Ro S, Huang M, Iskander KS, Lenihan D. Analysis of carfilzomib cardiovascular safety profile across relapsed and/or refractory multiple myeloma clinical trials. Blood Adv. 2018 Jul 10;2(13):1633-1644. doi: 10.1182/bloodadvances.2017015545.
- Facon T, Niesvizky R, Mateos MV, Siegel D, Rosenbaum C, Bringhen S, Weisel K, Ho PJ, Ludwig H, Kumar S, Wang K, Obreja M, Yang Z, Klippel Z, Mezzi K, Goldrick A, Tekle C, Dimopoulos MA. Efficacy and safety of carfilzomib-based regimens in frail patients with relapsed and/or refractory multiple myeloma. Blood Adv. 2020 Nov 10;4(21):5449-5459. doi: 10.1182/bloodadvances.2020001965.
- Hari P, Mateos MV, Abonour R, Knop S, Bensinger W, Ludwig H, Song K, Hajek R, Moreau P, Siegel DS, Feng S, Obreja M, Aggarwal SK, Iskander K, Goldschmidt H. Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes. Leukemia. 2017 Dec;31(12):2630-2641. doi: 10.1038/leu.2017.122. Epub 2017 Apr 25.
- Leleu X, Martin TG, Einsele H, Lyons RM, Durie BGM, Iskander KS, Ailawadhi S. Role of Proteasome Inhibitors in Relapsed and/or Refractory Multiple Myeloma. Clin Lymphoma Myeloma Leuk. 2019 Jan;19(1):9-22. doi: 10.1016/j.clml.2018.08.016. Epub 2018 Sep 5.
- Mateos MV, Goldschmidt H, San-Miguel J, Mikhael J, DeCosta L, Zhou L, Obreja M, Blaedel J, Szabo Z, Leleu X. Carfilzomib in relapsed or refractory multiple myeloma patients with early or late relapse following prior therapy: A subgroup analysis of the randomized phase 3 ASPIRE and ENDEAVOR trials. Hematol Oncol. 2018 Apr;36(2):463-470. doi: 10.1002/hon.2499. Epub 2018 Feb 15.
- Siegel DS, Dimopoulos MA, Ludwig H, Facon T, Goldschmidt H, Jakubowiak A, San-Miguel J, Obreja M, Blaedel J, Stewart AK. Improvement in Overall Survival With Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma. J Clin Oncol. 2018 Mar 10;36(8):728-734. doi: 10.1200/JCO.2017.76.5032. Epub 2018 Jan 17.
- Weisel K, Mateos MV, Gay F, Delforge M, Cook G, Szabo Z, Desgraz R, DeCosta L, Moreau P. Efficacy and safety profile of deep responders to carfilzomib-based therapy: a subgroup analysis from ASPIRE and ENDEAVOR. Leukemia. 2021 Jun;35(6):1732-1744. doi: 10.1038/s41375-020-01049-5. Epub 2020 Oct 16.
- Stewart AK, Rajkumar SV, Dimopoulos MA, Masszi T, Spicka I, Oriol A, Hajek R, Rosinol L, Siegel DS, Mihaylov GG, Goranova-Marinova V, Rajnics P, Suvorov A, Niesvizky R, Jakubowiak AJ, San-Miguel JF, Ludwig H, Wang M, Maisnar V, Minarik J, Bensinger WI, Mateos MV, Ben-Yehuda D, Kukreti V, Zojwalla N, Tonda ME, Yang X, Xing B, Moreau P, Palumbo A; ASPIRE Investigators. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med. 2015 Jan 8;372(2):142-52. doi: 10.1056/NEJMoa1411321. Epub 2014 Dec 6.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年7月14日
初级完成 (实际的)
2014年6月16日
研究完成 (实际的)
2017年12月5日
研究注册日期
首次提交
2010年3月2日
首先提交符合 QC 标准的
2010年3月2日
首次发布 (估计)
2010年3月4日
研究记录更新
最后更新发布 (实际的)
2022年9月21日
上次提交的符合 QC 标准的更新
2022年9月8日
最后验证
2022年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.