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
1 other identifier
interventional
559
22 countries
321
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Jan 2013
Longer than P75 for phase_3 multiple-myeloma
321 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2012
CompletedFirst Posted
Study publicly available on registry
November 28, 2012
CompletedStudy Start
First participant enrolled
January 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2022
CompletedResults Posted
Study results publicly available
June 6, 2023
CompletedJune 6, 2023
May 1, 2023
9.3 years
November 23, 2012
May 9, 2023
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Overall Survival (OS)
From randomization to date of death, up to approximately 65 months
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
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)
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)
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)
From first dose to 28 days after the last dose (up to approximately 44 months
Study Arms (2)
Pomalidomide, Bortezomib and Low Dose Dexamethasone
EXPERIMENTAL4 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.
Bortezomib and Low Dose Dexamethasone
ACTIVE COMPARATOR1.3 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.
Interventions
Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (321)
Southern Cancer Center
Mobile, Alabama, 36608, United States
Arizona Oncology
Tucson, Arizona, 85710, United States
University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Alta Bates Comprehensive Cancer Center
Berkeley, California, 94704, United States
University of California San Francisco Fresno Campus
Fresno, California, 93701, United States
Marin Oncology Associates
Greenbrae, California, 94904-2007, United States
Moore UCSD Cancer Center
La Jolla, California, 92083, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, 95403, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Cancer Center of Central Connecticut
Southington, Connecticut, 06489, United States
Local Institution - 153
Southington, Connecticut, 06489, United States
George Washington Medical Center
Washington D.C., District of Columbia, 20037, United States
Lynn Cancer Institute
Boca Raton, Florida, 33486, United States
University Cancer Institute
Boynton Beach, Florida, 33426, United States
Broward Oncology Associates PA
Fort Lauderdale, Florida, 33308, United States
Broward Oncology Assoc.
Fort Lauderdale, Florida, 33316, United States
University of Florida
Gainesville, Florida, 32610, United States
Alves Domenech Oncology and Hematology Clinic
Hollywood, Florida, 33021, United States
Palm Beach Cancer Institute, LLC
West Palm Beach, Florida, 33401, United States
Local Institution - 135
Marietta, Georgia, 30060, United States
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
Marietta, Georgia, 30060, United States
University of Chicago
Chicago, Illinois, 60637-1470, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis, Indiana, 46254, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Western Kentucky Hematology and Oncology Group, PSC
Paducah, Kentucky, 42003, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Cancer Care of Maine
Bangor, Maine, 04401, United States
Local Institution - 132
Bangor, Maine, 04401, United States
St. Agnes - Medical Center
Baltimore, Maryland, 21229-5299, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Local Institution - 125
Bethesda, Maryland, 20817, United States
Medstar Health Research Institute
Hyattsville, Maryland, 20782, United States
Local Institution - 299
Boston, Massachusetts, 02114, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Local Institution - 100
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Local Institution - 298
Boston, Massachusetts, 02215, United States
Henry Ford Medical Center - New Center One
Detroit, Michigan, 48202-268, United States
Local Institution - 178
Detroit, Michigan, 48202-268, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546, United States
Detroit Clinical Research Center
Lansing, Michigan, 48912, United States
Beaumont Cancer Center
Royal Oak, Michigan, 48073, United States
Essentia Health Duluth CCOP
Duluth, Minnesota, 55805, United States
Metro MN CCOP
Saint Louis Park, Minnesota, 55416, United States
Columbia Comprehensive
Jefferson City, Missouri, 65203, United States
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City, Missouri, 64128, United States
St. John's Clinic Cancerand Hematology - Springfield
Springfield, Missouri, 65804, United States
St John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Billings Clinic
Billings, Montana, 59102, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
CarePoint Health Research Institute
Jersey City, New Jersey, 07306, United States
Hematology-Oncology Associates of NNJ, P
Morristown, New Jersey, 07960, United States
Somerset Hematology-Oncology Associates
Somerville, New Jersey, 08876, United States
Mount Sinai Hospital
New York, New York, 10029, United States
Stony Brook University
Stony Brook, New York, 11794-7300, United States
Local Institution - 186
The Bronx, New York, 10467, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
New York Medical College
Valhalla, New York, 10595, United States
Eastern Institute of Medical Sciences
Greenville, North Carolina, 27834, United States
Boice-Willis Clinic P.A.
Rocky Mount, North Carolina, 27804, United States
Gabrail Cancer Center Research
Canton, Ohio, 44718, United States
Local Institution - 111
Canton, Ohio, 44718, United States
MetroHealth Medical Systems
Cleveland, Ohio, 44109, United States
Mid Ohio Oncology Hematology Inc
Columbus, Ohio, 43219, United States
University of Toledo Medical Center
Toledo, Ohio, 43614, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Med Univ of South Carolina
Charleston, South Carolina, 29425, United States
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Spartanburg, South Carolina, 29303, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Local Institution - 167
Watertown, South Dakota, 57201, United States
Prairie Lakes Health Care System
Watertown, South Dakota, 57201, United States
University of Tennessee Medical Center - Cancer Institute
Knoxville, Tennessee, 37885, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-5505, United States
Local Institution - 114
Dallas, Texas, 75390, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston, Texas, 78235-8200, United States
Local Institution - 103
Fort Sam Houston, Texas, 78235-8200, United States
Local Institution - 130
Houston, Texas, 77090, United States
Northwest Cancer Center
Houston, Texas, 77090, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410, United States
Utah Cancer Specialist
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
Swedish Cancer Inst
Seattle, Washington, 98104, United States
Medical Oncology Associates
Spokane, Washington, 99208, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Local Institution - 139
Morgantown, West Virginia, 25606, United States
West Virginia University CTRU
Morgantown, West Virginia, 25606, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
Local Institution - 136
Milwaukee, Wisconsin, 53226, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Hospital St. Polten
Sankt Pölten, 3100, Austria
Local Institution - 523
Sankt Pölten, 3100, Austria
Local Institution - 480
Vienna, 1090, Austria
Medical University of Vienna
Vienna, 1090, Austria
Local Institution - 481
Vienna, 1160, Austria
Wilhelminenspital-Center for Hematology and Oncology
Vienna, 1160, Austria
Local Institution - 308
Oshawa, Ontario, L1G 2B9, Canada
RSM Durham Regional Cancer Center - Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
CSSS Champlain Charles LeMoyne
Greenfield Park, Quebec, J4V 2H1, Canada
Local Institution - 301
Greenfield Park, Quebec, J4V 2H1, Canada
Centre De Sante Et De Services Sociaux De Rimouski-Neigette
Rimouski, Quebec, G5L5T1, Canada
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
Sherbrooke, Quebec, J1H5N4, Canada
Local Institution - 307
Sherbrooke, Quebec, J1H5N4, Canada
Local Institution - 304
Halifax, B3H 2Y9, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, B3H 2Y9, Canada
Aarhus University Hospital
Aarhus, 8000, Denmark
Local Institution - 447
Aarhus, 8000, Denmark
Copenhagen University Hospital Rigshosptalet
Copenhagen, 2100, Denmark
Local Institution - 506
Copenhagen, 2100, Denmark
Local Institution - 400
Odense, DK-5000, Denmark
Odense University Hospital
Odense, DK-5000, Denmark
Local Institution - 499
Vejle, 7100, Denmark
Vejle Hospital
Vejle, 7100, Denmark
Helsinki University Central Hospital
Helsinki, 290, Finland
Local Institution - 455
Helsinki, 290, Finland
Hyvinkaa Hospital
Hyvinkää, 05850, Finland
Local Institution - 510
Hyvinkää, 05850, Finland
Centre Hospitalier de la cote basque
Bayonne, 64109, France
Local Institution - 469
Bayonne, 64109, France
Centre Hospitalier William Morey
Chalon-sur-Saône, 71100, France
Local Institution - 498
Chalon-sur-Saône, 71100, France
CHU Hotel
Grenoble, 38043, France
Local Institution - 483
Grenoble, 38043, France
GH Institut Catholique St Vincent
Lille, 59000, France
CHRU de Lille-Hopital Claude Huriez
Lille, 59037, France
Local Institution - 476
Lille, 59037, France
CHRU Hotel Dieu
Nantes, 44035, France
Local Institution - 486
Nantes, 44035, France
Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine
Paris, 75012, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Local Institution - 497
Pierre-Bénite, 69495, France
CHU La Miletrie
Poitiers, 86021, France
Local Institution - 516
Poitiers, 86021, France
CHRU Rennes
Rennes, 35033, France
Local Institution - 504
Rennes, 35033, France
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse, 31052, France
CHRU Hopital Bretonneau
Tours, 37044, France
Local Institution - 468
Tours, 37044, France
ChariteUniversitatsmedizinCampus Benjamin Franklin
Berlin, D-13353, Germany
Local Institution - 442
Berlin, D-13353, Germany
Local Institution - 417
Dresden, 01307, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, 01307, Germany
Local Institution - 475
Essen, 45147, Germany
Universitaetsklinikum EssenInnere Klinik und Poliklinik
Essen, 45147, Germany
Local Institution - 496
Freiburg im Breisgau, 79106, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Local Institution - 430
Heidelberg, 69120, Germany
University of Heidelberg
Heidelberg, 69120, Germany
Local Institution - 410
Tübingen, 72076, Germany
UKT Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
General Hospital of Athens Evangelismos
Athens, 10676, Greece
Local Institution - 484
Athens, 10676, Greece
Local Institution - 422
Athens, 11528, Greece
University of Athens Medical school - Regional General Hospital
Athens, 11528, Greece
Local Institution - 487
Mezourlo, 41110, Greece
University General Hospital of Larissa
Mezourlo, 41110, Greece
George Papanikolaou General Hospital of Thessaloniki
Thessloniki, 57010, Greece
Local Institution - 465
Thessloniki, 57010, Greece
Local Institution - 462
Dublin, Dublin 7, Ireland
Mater Misericordiae University Hospital
Dublin, Dublin 7, Ireland
Local Institution - 431
Dublin, Dublin 8, Ireland
St James Hospital
Dublin, Dublin 8, Ireland
Local Institution - 413
Galway, ST46QG, Ireland
University College Hospital Galway
Galway, ST46QG, Ireland
Rambam Health Care Campus
Haifa, 31096, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Local Institution - 457
Jerusalem, 91120, Israel
Local Institution - 433
Kfar Saba, 44281, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv, 64239, Israel
Local Institution - 449
Bergamo, 24127, Italy
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Local Institution - 456
Bologna, 40138, Italy
Policlinico S. Orsola - Malpighi
Bologna, 40138, Italy
Local Institution - 415
Catania, 95124, Italy
Ospedale Ferrarotto
Catania, 95124, Italy
Local Institution - 403
Modena, 41100, Italy
University of Modena
Modena, 41100, Italy
IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Local Institution - 451
Pavia, 27100, Italy
Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara
Pescara, 65124, Italy
Local Institution - 441
Pescara, 65124, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia, 42100, Italy
Local Institution - 414
Reggio Emilia, 42100, Italy
La Sapienza, University of Rome
Rome, 00161, Italy
Local Institution - 460
Rome, 00161, Italy
A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
Salerno, 84131, Italy
Local Institution - 459
Salerno, 84131, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
Local Institution - 453
San Giovanni Rotondo, 71013, Italy
Azienda Ospedaliera S Maria di Terni
Terni, 05100, Italy
Local Institution - 402
Terni, 05100, Italy
Azienda Ospedaliera San Giovanni Battista
Torino, 10126, Italy
Local Institution - 401
Torino, 10126, Italy
Hitachi General Hospital
Hitachi, Ibaraki, 317-0077, Japan
Local Institution - 620
Hitachi, Ibaraki, 317-0077, Japan
Kameda Medical Center
Kamogawa, 296-8602, Japan
Local Institution - 625
Kamogawa, 296-8602, Japan
Local Institution - 626
Okayama, 701-1192, Japan
Okayama Medical Center
Okayama, 701-1192, Japan
Japan Red Cross Medical Center
Shibuya-ku, 150-8935, Japan
Local Institution - 623
Shibuya-ku, 150-8935, Japan
Local Institution - 622
Tachikawa, 190-0014, Japan
National Hospital Organization Disaster Medical Center
Tachikawa, 190-0014, Japan
Local Institution - 514
Groningen, 9713 GZ, Netherlands
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Erasmus Medical Center
Rotterdam, 3015 CN, Netherlands
Local Institution - 494
Rotterdam, 3015 CN, Netherlands
Local Institution - 412
Oslo, 0372, Norway
Oslo universitetssykehus, Rikshospitalet
Oslo, 0372, Norway
St Olavs Hospital
Trondheim, 7006, Norway
Local Institution - 411
Brzozów, 36-200, Poland
Szpital Specjalistyczny w Brzozowie
Brzozów, 36-200, Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz, 85-168, Poland
Local Institution - 407
Chorzów, 41-500, Poland
Zespol Szpitali Miejskich
Chorzów, 41-500, Poland
Klinika Hematologii Akademii Medycznej w Gdansku
Gdansk, 80-952, Poland
Local Institution - 463
Gdansk, 80-952, Poland
Local Institution - 440
Krakow, 31-501, Poland
Oddzial Kliniczny Kliniki Hematologii
Krakow, 31-501, Poland
Kopernik Memorial Hospital
Lodz, 93-510, Poland
Local Institution - 418
Lodz, 93-510, Poland
Klinika Hematoonkologii i Transplantacji Szpiku
Lublin, 20-081, Poland
Local Institution - 439
Lublin, 20-081, Poland
Local Institution - 437
Poznan, 60-569, Poland
Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
Poznan, 60-569, Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Local Institution - 448
Warsaw, 02-781, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Local Institution - 450
Braga, 4710-243, Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisbon, 1099-023, Portugal
Local Institution - 454
Lisbon, 1099-023, Portugal
Fundacao Champalimaud
Lisbon, 1400-038, Portugal
Local Institution - 473
Lisbon, 1400-038, Portugal
Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Local Institution - 466
Lisbon, 1649-035, Portugal
Local Institution - 464
Porto, 0, Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto, 4200-072, Portugal
Local Institution - 425
Porto, 4200-072, Portugal
Hospital de Santo Antonio- Porto
Porto, Portugal
Ad-Vance Medical Research, LLC
Ponce, 00717, Puerto Rico
City Clinical Hospital 52
Moscow, 123182, Russia
Local Institution - 521
Moscow, 123182, Russia
Local Institution - 517
Moscow, 125284, Russia
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow, 125284, Russia
Local Institution - 520
Nizhny Novgorod, 603126, Russia
State Budgetary Healthcare Institution of Nizhniy Novgorod Region
Nizhny Novgorod, 603126, Russia
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
Saint Petersburg, 191024, Russia
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona), 08916, Spain
Local Institution - 423
Badalona (Barcelona), 08916, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Local Institution - 424
Barcelona, 08036, Spain
Hospital de Basurto-Osakidetza
Bilbao, 48013, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Local Institution - 452
Madrid, 28041, Spain
Hospital Morales Meseguer
Murcia, 30008, Spain
Local Institution - 502
Murcia, 30008, Spain
Complejo Hospitalario De Orense
Ourense, 32005, Spain
Local Institution - 526
Ourense, 32005, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Local Institution - 434
Pamplona, 31008, Spain
Complejo Hospitalario Nuestra Senora de Valme
Seville, 41014, Spain
Local Institution - 492
Seville, 41014, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Falu lasarett
Falun, 79182, Sweden
Local Institution - 426
Falun, 79182, Sweden
Local Institution - 478
Gothenburg, 60 Gothenburg, Sweden
Sahlgrenska University Hospital
Gothenburg, 60 Gothenburg, Sweden
Local Institution - 429
Luleå, SE-971 80, Sweden
Sunderby Sjukhus
Luleå, SE-971 80, Sweden
Karolinska University
Stockholm, 14186, Sweden
Local Institution - 471
Stockholm, 14186, Sweden
Sundsvalls sjukhus- Medicinkliniken
Sundsvall, S-85643, Sweden
Ankara University Medical Faculty Cebeci Hospital
Ankara, 06590, Turkey (Türkiye)
Local Institution - 428
Ankara, 06590, Turkey (Türkiye)
Gazi Universitesi Tip Fakultesi Hastanesi
Ankara, 6500, Turkey (Türkiye)
Local Institution - 409
Ankara, 6500, Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi
Ankara, Dikimevi Cebeci, Turkey (Türkiye)
Local Institution - 408
Ankara, Dikimevi Cebeci, Turkey (Türkiye)
Local Institution - 488
Antalya, 07050, Turkey (Türkiye)
Medstar Antalya Hospital
Antalya, 07050, Turkey (Türkiye)
Eskisehir Osmangazi University
Eskişehir, 26480, Turkey (Türkiye)
Local Institution - 420
Eskişehir, 26480, Turkey (Türkiye)
Local Institution - 421
Gaziantep, 0, Turkey (Türkiye)
Gaziantep University
Gaziantep, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Local Institution - 445
Istanbul, 34098, Turkey (Türkiye)
Istanbul University Faculty of Medicine
Istanbul, 34390, Turkey (Türkiye)
Local Institution - 474
Istanbul, 34390, Turkey (Türkiye)
Ege University Medical School
Izmir, 35100, Turkey (Türkiye)
Local Institution - 419
Izmir, 35100, Turkey (Türkiye)
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon, 61080, Turkey (Türkiye)
Local Institution - 404
Trabzon, 61080, Turkey (Türkiye)
The Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Kent and Canterbury Hospital
Canterbury Kent, CT1 3NG, United Kingdom
Local Institution - 479
Canterbury Kent, CT1 3NG, United Kingdom
Local Institution - 406
Edinburgh Scotland, EH4 2XU, United Kingdom
Western General Hospital
Edinburgh Scotland, EH4 2XU, United Kingdom
Local Institution - 490
London, NW1 2PG, United Kingdom
University College London Hospitals
London, NW1 2PG, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Local Institution - 461
London, SE5 9RS, United Kingdom
Local Institution - 512
Oxford, OX3 7DQ, United Kingdom
University of Oxford
Oxford, OX3 7DQ, United Kingdom
Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit
Plymouth, PL6 8DH, United Kingdom
Local Institution - 515
Plymouth, PL6 8DH, United Kingdom
Local Institution - 500
Sheffield, S10 2JF, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Local Institution - 493
Southampton, SO16 6YD, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
University Hospital of North Staffordshire Nhs Trust - City General Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Local Institution - 405
Swansea, SA2 8QA, United Kingdom
Singleton Hospital
Swansea, SA2 8QA, United Kingdom
Local Institution - 482
Wolverhampton, WV10 OPQ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 OPQ, United Kingdom
Local Institution - 436
Worcester, WR5 1DD, United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, WR5 1DD, United Kingdom
Related Publications (2)
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.
PMID: 31097405DERIVEDRichardson 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.
PMID: 28642620DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol Myers-Squibb
Bristol-Myers Squibb
- STUDY DIRECTOR
Amine Bensmaine, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2012
First Posted
November 28, 2012
Study Start
January 7, 2013
Primary Completion
May 9, 2022
Study Completion
May 13, 2022
Last Updated
June 6, 2023
Results First Posted
June 6, 2023
Record last verified: 2023-05