Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (OPTIMISMM)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Pomalidomide
Eligibility Criteria
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.
Sites / Locations
- Southern Cancer Center
- Arizona Oncology
- University of Arizona Cancer Center
- Alta Bates Comprehensive Cancer Center
- University of California San Francisco Fresno Campus
- Marin Oncology Associates
- Moore UCSD Cancer Center
- USC Norris Comprehensive Cancer Center
- Sutter Pacific Medical Foundation
- University of Colorado Cancer Center
- Cancer Center of Central Connecticut
- Local Institution - 153
- George Washington Medical Center
- Lynn Cancer Institute
- University Cancer Institute
- Broward Oncology Associates PA
- Broward Oncology Assoc.
- University of Florida
- Alves Domenech Oncology and Hematology Clinic
- Palm Beach Cancer Institute, LLC
- Local Institution - 135
- Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
- University of Chicago
- Investigative Clinical Research of Indiana, LLC
- University of Iowa
- Western Kentucky Hematology and Oncology Group, PSC
- Tulane University Medical Center
- Cancer Care of Maine
- Local Institution - 132
- St. Agnes - Medical Center
- Center for Cancer and Blood Disorders
- Local Institution - 125
- Medstar Health Research Institute
- Local Institution - 299
- Massachusetts General Hospital
- Dana Farber Cancer Institute
- Local Institution - 100
- Beth Israel Deaconess Medical Center
- Local Institution - 298
- Henry Ford Medical Center - New Center One
- Local Institution - 178
- Cancer and Hematology Centers of Western Michigan
- Detroit Clinical Research Center
- Beaumont Cancer Center
- Essentia Health Duluth CCOP
- Metro MN CCOP
- Columbia Comprehensive
- Kansas City VA Medical Center University of Kansas Medical Center
- St John's Mercy Medical Center
- St. John's Clinic Cancerand Hematology - Springfield
- Billings Clinic
- Southeast Nebraska Cancer Center
- CarePoint Health Research Institute
- Hematology-Oncology Associates of NNJ, P
- Somerset Hematology-Oncology Associates
- Local Institution - 186
- Montefiore Medical Center
- Mount Sinai Hospital
- Stony Brook University
- New York Medical College
- Eastern Institute of Medical Sciences
- Boice-Willis Clinic P.A.
- Gabrail Cancer Center Research
- Local Institution - 111
- MetroHealth Medical Systems
- Mid Ohio Oncology Hematology Inc
- University of Toledo Medical Center
- Providence Portland Medical Center
- Med Univ of South Carolina
- Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
- Avera Research Institute
- Local Institution - 167
- Prairie Lakes Health Care System
- University of Tennessee Medical Center - Cancer Institute
- Vanderbilt University Medical Center
- Local Institution - 114
- UT Southwestern Medical Center
- Brooke Army Medical Center Francis Street Medical Center
- Local Institution - 103
- Local Institution - 130
- Northwest Cancer Center
- Joe Arrington Cancer Research and Treatment Center
- Utah Cancer Specialist
- Huntsman Cancer Institute at the University of Utah
- Swedish Cancer Inst
- Medical Oncology Associates
- Wenatchee Valley Hospital and Clinics
- Local Institution - 139
- West Virginia University CTRU
- University of Wisconsin
- Local Institution - 136
- Medical College of Wisconsin
- Hospital St. Polten
- Local Institution - 523
- Local Institution - 480
- Medical University of Vienna
- Local Institution - 481
- Wilhelminenspital-Center for Hematology and Oncology
- Local Institution - 308
- RSM Durham Regional Cancer Center - Lakeridge Health Oshawa
- CSSS Champlain Charles LeMoyne
- Local Institution - 301
- Centre De Sante Et De Services Sociaux De Rimouski-Neigette
- Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
- Local Institution - 307
- Local Institution - 304
- Queen Elizabeth II Health Sciences Centre
- Aarhus University Hospital
- Local Institution - 447
- Copenhagen University Hospital Rigshosptalet
- Local Institution - 506
- Local Institution - 400
- Odense University Hospital
- Local Institution - 499
- Vejle Hospital
- Helsinki University Central Hospital
- Local Institution - 455
- Hyvinkaa Hospital
- Local Institution - 510
- Centre Hospitalier de la cote basque
- Local Institution - 469
- Centre Hospitalier William Morey
- Local Institution - 498
- CHU Hotel
- Local Institution - 483
- GH Institut Catholique St Vincent
- CHRU de Lille-Hopital Claude Huriez
- Local Institution - 476
- CHRU Hotel Dieu
- Local Institution - 486
- Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine
- Centre Hospitalier Lyon Sud
- Local Institution - 497
- CHU La Miletrie
- Local Institution - 516
- CHRU Rennes
- Local Institution - 504
- Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
- CHRU Hopital Bretonneau
- Local Institution - 468
- ChariteUniversitatsmedizinCampus Benjamin Franklin
- Local Institution - 442
- Local Institution - 417
- Universitaetsklinikum Carl Gustav Carus
- Local Institution - 475
- Universitaetsklinikum EssenInnere Klinik und Poliklinik
- Local Institution - 496
- Universitatsklinikum Freiburg
- Local Institution - 430
- University of Heidelberg
- Local Institution - 410
- UKT Universitaetsklinikum Tuebingen
- General Hospital of Athens Evangelismos
- Local Institution - 484
- Local Institution - 422
- University of Athens Medical school - Regional General Hospital
- Local Institution - 487
- University General Hospital of Larissa
- George Papanikolaou General Hospital of Thessaloniki
- Local Institution - 465
- Local Institution - 462
- Mater Misericordiae University Hospital
- Local Institution - 431
- St James Hospital
- Local Institution - 413
- University College Hospital Galway
- Rambam Health Care Campus
- Hadassah Medical Center
- Local Institution - 457
- Local Institution - 433
- Meir Medical Center
- Chaim Sheba Medical Center
- Tel Aviv Sourasky Medical Center Department of Hematology
- Local Institution - 449
- USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
- Local Institution - 456
- Policlinico S. Orsola - Malpighi
- Local Institution - 415
- Ospedale Ferrarotto
- Local Institution - 403
- University of Modena
- IRCCS Policlinico San Matteo
- Local Institution - 451
- Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara
- Local Institution - 441
- Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
- Local Institution - 414
- La Sapienza, University of Rome
- Local Institution - 460
- A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
- Local Institution - 459
- IRCCS Casa Sollievo della Sofferenza
- Local Institution - 453
- Azienda Ospedaliera S Maria di Terni
- Local Institution - 402
- Azienda Ospedaliera San Giovanni Battista
- Local Institution - 401
- Hitachi General Hospital
- Local Institution - 620
- Kameda Medical Center
- Local Institution - 625
- Local Institution - 626
- Okayama Medical Center
- Japan Red Cross Medical Center
- Local Institution - 623
- Local Institution - 622
- National Hospital Organization Disaster Medical Center
- Local Institution - 514
- Universitair Medisch Centrum Groningen
- Medisch Centrum Leeuwarden
- Erasmus Medical Center
- Local Institution - 494
- Local Institution - 412
- Oslo universitetssykehus, Rikshospitalet
- St Olavs Hospital
- Local Institution - 411
- Szpital Specjalistyczny w Brzozowie
- Szpital Uniwersytecki nr 2 im dr. Jana Biziela
- Local Institution - 407
- Zespol Szpitali Miejskich
- Klinika Hematologii Akademii Medycznej w Gdansku
- Local Institution - 463
- Local Institution - 440
- Oddzial Kliniczny Kliniki Hematologii
- Kopernik Memorial Hospital
- Local Institution - 418
- Klinika Hematoonkologii i Transplantacji Szpiku
- Local Institution - 439
- Local Institution - 437
- Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
- Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
- Local Institution - 448
- Hospital de Braga
- Local Institution - 450
- Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
- Local Institution - 454
- Hospital de Santa Maria
- Local Institution - 466
- Fundacao Champalimaud
- Local Institution - 473
- Local Institution - 464
- Instituto Portugues de Oncologia do Porto, Francisco Gentil
- Local Institution - 425
- Hospital de Santo Antonio- Porto
- Ad-Vance Medical Research, LLC
- City Clinical Hospital 52
- Local Institution - 521
- Local Institution - 517
- Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
- Local Institution - 520
- State Budgetary Healthcare Institution of Nizhniy Novgorod Region
- Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
- Hospital Universitari Germans Trias i Pujol Can Ruti
- Local Institution - 423
- Hospital Clinic de Barcelona
- Local Institution - 424
- Hospital de Basurto-Osakidetza
- Hospital 12 de Octubre
- Local Institution - 452
- Hospital Morales Meseguer
- Local Institution - 502
- Complejo Hospitalario De Orense
- Local Institution - 526
- Clinica Universidad de Navarra
- Local Institution - 434
- Complejo Hospitalario Nuestra Senora de Valme
- Local Institution - 492
- Hospital Universitario y Politecnico La Fe
- Falu lasarett
- Local Institution - 426
- Local Institution - 478
- Sahlgrenska University Hospital
- Local Institution - 429
- Sunderby Sjukhus
- Karolinska University
- Local Institution - 471
- Sundsvalls sjukhus- Medicinkliniken
- Ankara University Medical Faculty Cebeci Hospital
- Local Institution - 428
- Gazi Universitesi Tip Fakultesi Hastanesi
- Local Institution - 409
- Ankara Universitesi Tip Fakultesi
- Local Institution - 408
- Local Institution - 488
- Medstar Antalya Hospital
- Eskisehir Osmangazi University
- Local Institution - 420
- Local Institution - 421
- Gaziantep University
- Istanbul Universitesi Cerrahpasa Tip Fakultesi
- Local Institution - 445
- Istanbul University Faculty of Medicine
- Local Institution - 474
- Ege University Medical School
- Local Institution - 419
- Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
- Local Institution - 404
- The Royal Bournemouth Hospital
- Kent and Canterbury Hospital
- Local Institution - 479
- Local Institution - 406
- Western General Hospital
- Local Institution - 490
- University College London Hospitals
- Kings College Hospital
- Local Institution - 461
- Local Institution - 512
- University of Oxford
- Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit
- Local Institution - 515
- Local Institution - 500
- Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
- Local Institution - 493
- Southampton General Hospital
- University Hospital of North Staffordshire Nhs Trust - City General Hospital
- Local Institution - 405
- Singleton Hospital
- Local Institution - 482
- New Cross Hospital
- Local Institution - 436
- Worcestershire Acute Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Pomalidomide, Bortezomib and Low Dose Dexamethasone
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.
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.