Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM)

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide, Bortezomib and Low-Dose Dexamethasone Versus Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

The purpose of this study is to compare the efficacy of the combination of pomalidomide, bortezomib and low dose dexamethasone to the combination of bortezomib and low dose dexamethasone in participants with relapsed/refractory multiple myeloma. This study will also assess how safe the combination of pomalidomide, bortezomib and low dose dexamethasone is compared to the combination of bortezomib and low dose dexamethasone.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 559
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • St. Pölten, Austria, 3100
    • Hospital St. Polten
  • St. Pölten, Austria, 3100
    • Local Institution - 523
  • Vienna, Austria, 1090
    • Medical University of Vienna
  • Vienna, Austria, 1090
    • Local Institution - 480
  • Vienna, Austria, 1160
    • Local Institution - 481
  • Vienna, Austria, 1160
    • Wilhelminenspital-Center for Hematology and Oncology
• Canada
  • Halifax, Canada, B3H 2Y9
    • Local Institution - 304
  • Halifax, Canada, B3H 2Y9
    • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Oshawa, Ontario, Canada, L1G 2B9
      • RSM Durham Regional Cancer Center - Lakeridge Health Oshawa
    • Oshawa, Ontario, Canada, L1G 2B9
      • Local Institution - 308
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • CSSS Champlain Charles LeMoyne
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Local Institution - 301
    • Rimouski, Quebec, Canada, G5L5T1
      • Centre De Sante Et De Services Sociaux De Rimouski-Neigette
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
    • Sherbrooke, Quebec, Canada, J1H5N4
      • Local Institution - 307
• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Aarhus, Denmark, 8000
    • Local Institution - 447
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital Rigshosptalet
  • Copenhagen, Denmark, 2100
    • Local Institution - 506
  • Odense, Denmark, DK-5000
    • Odense University Hospital
  • Odense, Denmark, DK-5000
    • Local Institution - 400
  • Vejle, Denmark, 7100
    • Local Institution - 499
  • Vejle, Denmark, 7100
    • Vejle Hospital
• Finland
  • Helsinki, Finland, 290
    • Helsinki University Central Hospital
  • Helsinki, Finland, 290
    • Local Institution - 455
  • Hyvinkaa, Finland, 05850
    • Hyvinkää Hospital
  • Hyvinkaa, Finland, 05850
    • Local Institution - 510
• France
  • Bayonne, France, 64109
    • Centre Hospitalier de La Côte Basque
  • Bayonne, France, 64109
    • Local Institution - 469
  • Chalon sur Saone, France, 71100
    • Centre Hospitalier William Morey
  • Chalon sur Saone, France, 71100
    • Local Institution - 498
  • Grenoble Cedex 09, France, 38043
    • CHU Hotel
  • Grenoble Cedex 09, France, 38043
    • Local Institution - 483
  • Lille, France, 59000
    • GH Institut Catholique St Vincent
  • Lille, France, 59037
    • CHRU de Lille-Hôpital Claude Huriez
  • Lille, France, 59037
    • Local Institution - 476
  • Nantes, France, 44035
    • CHRU Hôtel Dieu
  • Nantes, France, 44035
    • Local Institution - 486
  • Paris, France, 75012
    • Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine
  • Pierre-Bénite Cedex, France, 69495
    • Centre Hospitalier Lyon Sud
  • Pierre-Bénite Cedex, France, 69495
    • Local Institution - 497
  • Poitiers Cedex, France, 86021
    • Chu La Miletrie
  • Poitiers Cedex, France, 86021
    • Local Institution - 516
  • Rennes, France, 35033
    • CHRU Rennes
  • Rennes, France, 35033
    • Local Institution - 504
  • Toulouse Cedex, France, 31052
    • Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
  • Tours cedex, France, 37044
    • CHRU Hôpital Bretonneau
  • Tours cedex, France, 37044
    • Local Institution - 468
• Germany
  • Berlin, Germany, D-13353
    • ChariteUniversitatsmedizinCampus Benjamin Franklin
  • Berlin, Germany, D-13353
    • Local Institution - 442
  • Dresden, Germany, 01307
    • Local Institution - 417
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus
  • Essen, Germany, 45147
    • Local Institution - 475
  • Essen, Germany, 45147
    • Universitaetsklinikum EssenInnere Klinik und Poliklinik
  • Freiburg, Germany, 79106
    • Universitatsklinikum Freiburg
  • Freiburg, Germany, 79106
    • Local Institution - 496
  • Heidelberg, Germany, 69120
    • University of Heidelberg
  • Heidelberg, Germany, 69120
    • Local Institution - 430
  • Tuebingen, Germany, 72076
    • Local Institution - 410
  • Tuebingen, Germany, 72076
    • UKT Universitaetsklinikum Tuebingen
• Greece
  • Athens, Greece, 10676
    • General Hospital of Athens Evangelismos
  • Athens, Greece, 11528
    • Local Institution - 422
  • Athens, Greece, 11528
    • University of Athens Medical school - Regional General Hospital
  • Athens, Greece, 10676
    • Local Institution - 484
  • Mezourlo, Greece, 41110
    • Local Institution - 487
  • Mezourlo, Greece, 41110
    • University General Hospital of Larissa
  • Thessloniki, Greece, 57010
    • George Papanikolaou General Hospital of Thessaloniki
  • Thessloniki, Greece, 57010
    • Local Institution - 465
• Ireland
  • Dublin, Ireland, Dublin 7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, Dublin 7
    • Local Institution - 462
  • Dublin, Ireland, Dublin 8
    • Local Institution - 431
  • Dublin, Ireland, Dublin 8
    • St James Hospital
  • Galway, Ireland, ST46QG
    • Local Institution - 413
  • Galway, Ireland, ST46QG
    • University College Hospital Galway
• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Jerusalem, Israel, 91120
    • Local Institution - 457
  • Kfar-Saba, Israel, 44281
    • Meir Medical Center
  • Kfar-Saba, Israel, 44281
    • Local Institution - 433
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center Department of Hematology
• Italy
  • Bergamo, Italy, 24127
    • USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
  • Bergamo, Italy, 24127
    • Local Institution - 449
  • Bologna, Italy, 40138
    • Policlinico S. Orsola - Malpighi
  • Bologna, Italy, 40138
    • Local Institution - 456
  • Catania, Italy, 95124
    • Ospedale Ferrarotto
  • Catania, Italy, 95124
    • Local Institution - 415
  • Modena, Italy, 41100
    • University of Modena
  • Modena, Italy, 41100
    • Local Institution - 403
  • Pavia, Italy, 27100
    • IRCCS Policlinico San Matteo
  • Pavia, Italy, 27100
    • Local Institution - 451
  • Pescara, Italy, 65124
    • Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara
  • Pescara, Italy, 65124
    • Local Institution - 441
  • Reggio Emilia, Italy, 42100
    • Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
  • Reggio Emilia, Italy, 42100
    • Local Institution - 414
  • Rome, Italy, 00161
    • La Sapienza, University of Rome
  • Rome, Italy, 00161
    • Local Institution - 460
  • Salerno, Italy, 84131
    • A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
  • Salerno, Italy, 84131
    • Local Institution - 459
  • San Giovanni Rotondo, Italy, 71013
    • IRCCS Casa Sollievo della Sofferenza
  • San Giovanni Rotondo, Italy, 71013
    • Local Institution - 453
  • Terni, Italy, 05100
    • Azienda Ospedaliera S Maria Di Terni
  • Terni, Italy, 05100
    • Local Institution - 402
  • Torino, Italy, 10126
    • Azienda Ospedaliera San Giovanni Battista
  • Torino, Italy, 10126
    • Local Institution - 401
• Japan
  • Hitachi, Ibaraki, Japan, 317-0077
    • Hitachi General Hospital
  • Hitachi, Ibaraki, Japan, 317-0077
    • Local Institution - 620
  • Kamogawa, Japan, 296-8602
    • Kameda Medical Center
  • Kamogawa, Japan, 296-8602
    • Local Institution - 625
  • Okayama, Japan, 701-1192
    • Local Institution - 626
  • Okayama, Japan, 701-1192
    • Okayama Medical Center
  • Shibuya-ku, Japan, 150-8935
    • Japan Red Cross Medical Center
  • Shibuya-ku, Japan, 150-8935
    • Local Institution - 623
  • Tachikawa, Japan, 190-0014
    • National Hospital Organization Disaster Medical Center
  • Tachikawa, Japan, 190-0014
    • Local Institution - 622
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen
  • Groningen, Netherlands, 9713 GZ
    • Local Institution - 514
  • Leeuwarden, Netherlands, 8934 AD
    • Medisch Centrum Leeuwarden
  • Rotterdam, Netherlands, 3015 CN
    • Erasmus Medical Center
  • Rotterdam, Netherlands, 3015 CN
    • Local Institution - 494
• Norway
  • Oslo, Norway, 0372
    • Local Institution - 412
  • Oslo, Norway, 0372
    • Oslo Universitetssykehus, Rikshospitalet
  • Trondheim, Norway, 7006
    • St Olavs hospital
• Poland
  • Brzozow, Poland, 36-200
    • Szpital Specjalistyczny w Brzozowie
  • Brzozow, Poland, 36-200
    • Local Institution - 411
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im dr. Jana Biziela
  • Chorzow, Poland, 41-500
    • Zespol Szpitali Miejskich
  • Chorzow, Poland, 41-500
    • Local Institution - 407
  • Gdansk, Poland, 80-952
    • Klinika Hematologii Akademii Medycznej w Gdansku
  • Gdansk, Poland, 80-952
    • Local Institution - 463
  • Krakow, Poland, 31-501
    • Oddzial Kliniczny Kliniki Hematologii
  • Krakow, Poland, 31-501
    • Local Institution - 440
  • Lodz, Poland, 93-510
    • Kopernik Memorial Hospital
  • Lodz, Poland, 93-510
    • Local Institution - 418
  • Lublin, Poland, 20-081
    • Klinika Hematoonkologii I Transplantacji Szpiku
  • Lublin, Poland, 20-081
    • Local Institution - 439
  • Poznan, Poland, 60-569
    • Local Institution - 437
  • Poznan, Poland, 60-569
    • Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
  • Warszawa, Poland, 02-781
    • Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
  • Warszawa, Poland, 02-781
    • Local Institution - 448
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Braga, Portugal, 4710-243
    • Local Institution - 450
  • Lisboa, Portugal, 1099-023
    • Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
  • Lisboa, Portugal, 1649-035
    • Hospital De Santa Maria
  • Lisboa, Portugal, 1099-023
    • Local Institution - 454
  • Lisboa, Portugal, 1649-035
    • Local Institution - 466
  • Lisbon, Portugal, 1400-038
    • Fundacao Champalimaud
  • Lisbon, Portugal, 1400-038
    • Local Institution - 473
  • Porto, Portugal, 4200-072
    • Instituto Portugues de Oncologia do Porto, Francisco Gentil
  • Porto, Portugal
    • Hospital de Santo Antonio- Porto
  • Porto, Portugal
    • Local Institution - 464
  • Porto, Portugal, 4200-072
    • Local Institution - 425
• Puerto Rico
  • Ponce, Puerto Rico, 00717
    • Ad-Vance Medical Research, LLC
• Russian Federation
  • Moscow, Russian Federation, 123182
    • City Clinical Hospital 52
  • Moscow, Russian Federation, 125284
    • Local Institution - 517
  • Moscow, Russian Federation, 125284
    • Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
  • Moscow, Russian Federation, 123182
    • Local Institution - 521
  • Nizhny Novgorod, Russian Federation, 603126
    • State Budgetary Healthcare Institution of Nizhniy Novgorod Region
  • Nizhny Novgorod, Russian Federation, 603126
    • Local Institution - 520
  • Saint Petersburg, Russian Federation, 191024
    • Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
• Spain
  • Badalona (Barcelona), Spain, 08916
    • Hospital Universitari Germans Trias i Pujol Can Ruti
  • Badalona (Barcelona), Spain, 08916
    • Local Institution - 423
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08036
    • Local Institution - 424
  • Bilbao, Spain, 48013
    • Hospital de Basurto-Osakidetza
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre
  • Madrid, Spain, 28041
    • Local Institution - 452
  • Murcia, Spain, 30008
    • Hospital Morales Meseguer
  • Murcia, Spain, 30008
    • Local Institution - 502
  • Orense, Spain, 32005
    • Complejo Hospitalario de Orense
  • Orense, Spain, 32005
    • Local Institution - 526
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Pamplona, Spain, 31008
    • Local Institution - 434
  • Sevilla, Spain, 41014
    • Complejo Hospitalario Nuestra Senora de Valme
  • Sevilla, Spain, 41014
    • Local Institution - 492
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe
• Sweden
  • Falun, Sweden, 79182
    • Falu Lasarett
  • Falun, Sweden, 79182
    • Local Institution - 426
  • Gothenburg, Sweden, 60 Gothenburg
    • Sahlgrenska University Hospital
  • Gothenburg, Sweden, 60 Gothenburg
    • Local Institution - 478
  • Luleå, Sweden, SE-971 80
    • Local Institution - 429
  • Luleå, Sweden, SE-971 80
    • Sunderby Sjukhus
  • Stockholm, Sweden, 14186
    • Karolinska University
  • Stockholm, Sweden, 14186
    • Local Institution - 471
  • Sundsvall, Sweden, S-85643
    • Sundsvalls sjukhus- Medicinkliniken
• Turkey
  • Ankara, Turkey, 6500
    • Gazi Universitesi Tip Fakultesi Hastanesi
  • Ankara, Turkey, 06590
    • Ankara University Medical Faculty Cebeci Hospital
  • Ankara, Turkey, 06590
    • Local Institution - 428
  • Ankara, Turkey, 6500
    • Local Institution - 409
  • Ankara, Turkey, Dikimevi Cebeci
    • Ankara Universitesi Tip Fakultesi
  • Ankara, Turkey, Dikimevi Cebeci
    • Local Institution - 408
  • Antalya, Turkey, 07050
    • Medstar Antalya Hospital
  • Antalya, Turkey, 07050
    • Local Institution - 488
  • Eskisehir, Turkey, 26480
    • Eskisehir Osmangazi University
  • Eskisehir, Turkey, 26480
    • Local Institution - 420
  • Gaziantep, Turkey
    • Local Institution - 421
  • Gaziantep, Turkey
    • Gaziantep University
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey, 34390
    • Istanbul University Faculty of Medicine
  • Istanbul, Turkey, 34390
    • Local Institution - 474
  • Istanbul, Turkey, 34098
    • Local Institution - 445
  • Izmir, Turkey, 35100
    • Ege University Medical School
  • Izmir, Turkey, 35100
    • Local Institution - 419
  • Trabzon, Turkey, 61080
    • Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
  • Trabzon, Turkey, 61080
    • Local Institution - 404
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • The Royal Bournemouth Hospital
  • Canterbury Kent, United Kingdom, CT1 3NG
    • Kent and Canterbury Hospital
  • Canterbury Kent, United Kingdom, CT1 3NG
    • Local Institution - 479
  • Edinburgh Scotland, United Kingdom, EH4 2XU
    • Local Institution - 406
  • Edinburgh Scotland, United Kingdom, EH4 2XU
    • Western General Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals
  • London, United Kingdom, NW1 2PG
    • Local Institution - 490
  • London, United Kingdom, SE5 9RS
    • Local Institution - 461
  • Oxford, United Kingdom, OX3 7DQ
    • Local Institution - 512
  • Oxford, United Kingdom, OX3 7DQ
    • University of Oxford
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit
  • Plymouth, United Kingdom, PL6 8DH
    • Local Institution - 515
  • Sheffield, United Kingdom, S10 2JF
    • Local Institution - 500
  • Sheffield, United Kingdom, S10 2JF
    • Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Local Institution - 493
  • Stoke-On-Trent, United Kingdom, ST4 6QG
    • University Hospital of North Staffordshire Nhs Trust - City General Hospital
  • Swansea, United Kingdom, SA2 8QA
    • Singleton Hospital
  • Swansea, United Kingdom, SA2 8QA
    • Local Institution - 405
  • Wolverhampton, United Kingdom, WV10 OPQ
    • Local Institution - 482
  • Wolverhampton, United Kingdom, WV10 OPQ
    • New Cross Hospital
  • Worcester, United Kingdom, WR5 1DD
    • Worcestershire Acute Hospitals NHS Trust
  • Worcester, United Kingdom, WR5 1DD
    • Local Institution - 436
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center
    • Tucson, Arizona, United States, 85710
      • Arizona Oncology
  • California
    • Berkeley, California, United States, 94704
      • Alta Bates Comprehensive Cancer Center
    • Fresno, California, United States, 93701
      • University of California San Francisco Fresno Campus
    • Greenbrae, California, United States, 94904-2007
      • Marin Oncology Associates
    • La Jolla, California, United States, 92083
      • Moore UCSD Cancer Center
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Santa Rosa, California, United States, 95403
      • Sutter Pacific Medical Foundation
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
  • Connecticut
    • Southington, Connecticut, United States, 06489
      • Cancer Center of Central Connecticut
    • Southington, Connecticut, United States, 06489
      • Local Institution - 153
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington Medical Center
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Lynn Cancer Institute
    • Boynton Beach, Florida, United States, 33426
      • University Cancer Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Broward Oncology Associates PA
    • Fort Lauderdale, Florida, United States, 33316
      • Broward Oncology Assoc.
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Hollywood, Florida, United States, 33021
      • Alves Domenech Oncology and Hematology Clinic
    • West Palm Beach, Florida, United States, 33401
      • Palm Beach Cancer Institute, LLC
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Local Institution - 135
    • Marietta, Georgia, United States, 30060
      • Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46254
      • Investigative Clinical Research of Indiana, LLC
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Western Kentucky Hematology and Oncology Group, PSC
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Medical Center
  • Maine
    • Bangor, Maine, United States, 04401
      • Cancer Care of Maine
    • Bangor, Maine, United States, 04401
      • Local Institution - 132
  • Maryland
    • Baltimore, Maryland, United States, 21229-5299
      • St. Agnes - Medical Center
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer and Blood Disorders
    • Bethesda, Maryland, United States, 20817
      • Local Institution - 125
    • Hyattsville, Maryland, United States, 20782
      • MedStar Health Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 299
    • Boston, Massachusetts, United States, 02115
      • Local Institution - 100
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 298
  • Michigan
    • Detroit, Michigan, United States, 48202-268
      • Henry Ford Medical Center - New Center One
    • Detroit, Michigan, United States, 48202-268
      • Local Institution - 178
    • Grand Rapids, Michigan, United States, 49546
      • Cancer and Hematology Centers of Western Michigan
    • Lansing, Michigan, United States, 48912
      • Detroit Clinical Research Center
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Cancer Center
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Duluth CCOP
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro MN CCOP
  • Missouri
    • Jefferson City, Missouri, United States, 65203
      • Columbia Comprehensive
    • Kansas City, Missouri, United States, 64128
      • Kansas City VA Medical Center University of Kansas Medical Center
    • Saint Louis, Missouri, United States, 63141
      • St John's Mercy Medical Center
    • Springfield, Missouri, United States, 65804
      • St. John's Clinic Cancerand Hematology - Springfield
  • Montana
    • Billings, Montana, United States, 59102
      • Billings Clinic
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Cancer Center
  • New Jersey
    • Jersey City, New Jersey, United States, 07306
      • CarePoint Health Research Institute
    • Morristown, New Jersey, United States, 07960
      • Hematology-Oncology Associates of NNJ, P
    • Somerville, New Jersey, United States, 08876
      • Somerset Hematology-Oncology Associates
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Bronx, New York, United States, 10467
      • Local Institution - 186
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • Stony Brook, New York, United States, 11794-7300
      • Stony Brook University
    • Valhalla, New York, United States, 10595
      • New York Medical College
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Eastern Institute of Medical Sciences
    • Rocky Mount, North Carolina, United States, 27804
      • Boice-Willis Clinic P.A.
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
    • Canton, Ohio, United States, 44718
      • Local Institution - 111
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Systems
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology Hematology Inc
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Med Univ of South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Research Institute
    • Watertown, South Dakota, United States, 57201
      • Local Institution - 167
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Health Care System
  • Tennessee
    • Knoxville, Tennessee, United States, 37885
      • University of Tennessee Medical Center - Cancer Institute
    • Nashville, Tennessee, United States, 37232-5505
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • Local Institution - 114
    • Fort Sam Houston, Texas, United States, 78235-8200
      • Brooke Army Medical Center Francis Street Medical Center
    • Fort Sam Houston, Texas, United States, 78235-8200
      • Local Institution - 103
    • Houston, Texas, United States, 77090
      • Local Institution - 130
    • Houston, Texas, United States, 77090
      • Northwest Cancer Center
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research and Treatment Center
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialist
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute at the University of Utah
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Inst
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associates
    • Wenatchee, Washington, United States, 98801
      • Wenatchee Valley Hospital and Clinics
  • West Virginia
    • Morgantown, West Virginia, United States, 25606
      • West Virginia University CTRU
    • Morgantown, West Virginia, United States, 25606
      • Local Institution - 139
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Local Institution - 136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Must be ≥ 18 years at the time of signing informed consent.
• Must have documented diagnosis of multiple myeloma and have measureable disease by serum and urine protein electrophoresis.
• Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
• Must have documented disease progression during or after their last anti-myeloma therapy.
• All subjects must have received prior treatment with a lenalidomide containing regimen for at least 2 consecutive cycles.

Exclusion Criteria:

• Documented progressive disease during therapy or within 60 days of the last dose of a bortezomib-containing therapy under the 1.3 mg/m^2 dose twice weekly dosing schedule.
• Peripheral neuropathy Grade 3, Grade 4 or Grade 2 with pain within 14 days prior to randomization.
• Non-secretory multiple myeloma.
• Subjects with severe renal impairment requiring dialysis.
• Previous therapy with pomalidomide.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomalidomide, Bortezomib and Low Dose Dexamethasone; 4 mg of Pomalidomide will be taken orally on Days 1-14 of a 21-day cycle along with 1.3 mg/m2 of Bortezomib administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression, and Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2,8, 9 of 21 days for cycles 9 and onward until disease progression.	Drug: Pomalidomide; Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.; Other Names: CC-4047; Oral Pomalidomide; Drug: Bortezomib; Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.; Other Names: Velcade; Drug: Dexamethasone; Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
Active Comparator: Bortezomib and Low Dose Dexamethasone; 1.3 mg/m2 of Bortezomib will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression along with Dexamethasone 20 mg/day [≤ 75 years old]or 10 mg/day [> 75 years old] orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.	Drug: Bortezomib; Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.; Other Names: Velcade; Drug: Dexamethasone; Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival by Independent Response Adjudication Committee (IRAC)	Progression free survival (PFS) will be calculated as the time between the randomization and progressive disease (PD) or death. Progressive Disease is defined as an Increase of ≥ 25% from nadir in: Serum M-component and/or (the absolute increase must be ≥ 0.5 g/dL)g; Urine M-component and/or (the absolute increase must be ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved FLC levels, the absolute increase must be > 100 mg/dL.; Bone marrow plasma cell percentage, the absolute % must be ≥ 10%h; Definite development of new bone lesions or soft tissue plasmacytomas increase in the size of existing bone lesions or soft tissue plasmacytomas. -Development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival (OS) is calculated as the time from randomization to death from any cause.	From randomization to date of death, up to approximately 65 months
Overall Response Rate by Independent Response Adjudication Committee (IRAC)	The ORR together with the relative proportions in each response category (ie, stringent CR [sCR], CR, very good PR [VGPR], PR, SD, and PD) by treatment using the IMWG criteria will be examined. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Duration of Response by Independent Response Adjudication Committee (IRAC)	Duration of myeloma response is defined as the duration from the time when the IMWG response criteria are first met for sCR or CR or VGPR or PR until the first date the response criteria are met for PD or until the subject died from any cause, whichever occurs first. Complete Response: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow SCR: CR+ Normal FLC ratio and Absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine Mprotein level < 100 mg per 24 hours PR: ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours Progressive Disease: Please refer to Primary outcome measure for definition SD: Not meeting criteria for CR, VGPR, PR, or progressive disease	From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)	Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.	From first dose to 28 days after the last dose (up to approximately 44 months
Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)	Treatment-emergent adverse events (TEAEs) are defined as any AE occurring or worsening on or after the first dose date of the study treatment and within 28 days after the last dose date.	From first dose to 28 days after the last dose (up to approximately 44 months

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Amine Bensmaine, MD, Celgene Corporation; Study Director: Bristol Myers-Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Richardson PG, Oriol A, Beksac M, Liberati AM, Galli M, Schjesvold F, Lindsay J, Weisel K, White D, Facon T, San Miguel J, Sunami K, O'Gorman P, Sonneveld P, Robak P, Semochkin S, Schey S, Yu X, Doerr T, Bensmaine A, Biyukov T, Peluso T, Zaki M, Anderson K, Dimopoulos M; OPTIMISMM trial investigators. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):781-794. doi: 10.1016/S1470-2045(19)30152-4. Epub 2019 May 13.
• Richardson PG, Hofmeister CC, Raje NS, Siegel DS, Lonial S, Laubach J, Efebera YA, Vesole DH, Nooka AK, Rosenblatt J, Doss D, Zaki MH, Bensmaine A, Herring J, Li Y, Watkins L, Chen MS, Anderson KC. Pomalidomide, bortezomib and low-dose dexamethasone in lenalidomide-refractory and proteasome inhibitor-exposed myeloma. Leukemia. 2017 Dec;31(12):2695-2701. doi: 10.1038/leu.2017.173. Epub 2017 Jun 2. Erratum In: Leukemia. 2018 Oct;32(10):2305.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2013
• Primary Completion (Actual): May 9, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: November 23, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimated): November 28, 2012

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Pomalidomide; Multiple Myeloma
• 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; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Dexamethasone; Thalidomide; Pomalidomide; Bortezomib
• Other Study ID Numbers: CC-4047-MM-007