search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pomalidomide
Bortezomib
Dexamethasone
Sponsored by
Celgene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Pomalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Active Comparator

Arm Label

Pomalidomide, Bortezomib and Low Dose Dexamethasone

Bortezomib and Low Dose Dexamethasone

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)
Overall survival (OS) is calculated as the time from randomization to death from any cause.
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
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
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.
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.

Full Information

First Posted
November 23, 2012
Last Updated
June 5, 2023
Sponsor
Celgene
search

1. Study Identification

Unique Protocol Identification Number
NCT01734928
Brief Title
Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
Acronym
OPTIMISMM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celgene

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Pomalidomide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
559 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomalidomide, Bortezomib and Low Dose Dexamethasone
Arm Type
Experimental
Arm Description
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.
Arm Title
Bortezomib and Low Dose Dexamethasone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pomalidomide
Other Intervention Name(s)
Oral Pomalidomide, CC-4047
Intervention Description
Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
Velcade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival by Independent Response Adjudication Committee (IRAC)
Description
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.
Time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS) is calculated as the time from randomization to death from any cause.
Time Frame
From randomization to date of death, up to approximately 65 months
Title
Overall Response Rate by Independent Response Adjudication Committee (IRAC)
Description
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
Time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Title
Duration of Response by Independent Response Adjudication Committee (IRAC)
Description
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
Time Frame
From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Title
Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)
Description
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.
Time Frame
From first dose to 28 days after the last dose (up to approximately 44 months
Title
Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)
Description
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.
Time Frame
From first dose to 28 days after the last dose (up to approximately 44 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol Myers-Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amine Bensmaine, MD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Southern Cancer Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Oncology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
University of California San Francisco Fresno Campus
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Marin Oncology Associates
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904-2007
Country
United States
Facility Name
Moore UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92083
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Sutter Pacific Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Cancer Center of Central Connecticut
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
Local Institution - 153
City
Southington
State/Province
Connecticut
ZIP/Postal Code
06489
Country
United States
Facility Name
George Washington Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University Cancer Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Broward Oncology Associates PA
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Broward Oncology Assoc.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Alves Domenech Oncology and Hematology Clinic
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Palm Beach Cancer Institute, LLC
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Local Institution - 135
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Western Kentucky Hematology and Oncology Group, PSC
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Tulane University Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Cancer Care of Maine
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Local Institution - 132
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
St. Agnes - Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229-5299
Country
United States
Facility Name
Center for Cancer and Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Local Institution - 125
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Medstar Health Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Local Institution - 299
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Local Institution - 100
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 298
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Medical Center - New Center One
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-268
Country
United States
Facility Name
Local Institution - 178
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-268
Country
United States
Facility Name
Cancer and Hematology Centers of Western Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Detroit Clinical Research Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Beaumont Cancer Center
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Essentia Health Duluth CCOP
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Metro MN CCOP
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Columbia Comprehensive
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Kansas City VA Medical Center University of Kansas Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
St John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
St. John's Clinic Cancerand Hematology - Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Southeast Nebraska Cancer Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
CarePoint Health Research Institute
City
Jersey City
State/Province
New Jersey
ZIP/Postal Code
07306
Country
United States
Facility Name
Hematology-Oncology Associates of NNJ, P
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Somerset Hematology-Oncology Associates
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Local Institution - 186
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-7300
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Eastern Institute of Medical Sciences
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Boice-Willis Clinic P.A.
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Local Institution - 111
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
MetroHealth Medical Systems
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Mid Ohio Oncology Hematology Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43219
Country
United States
Facility Name
University of Toledo Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Local Institution - 167
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Prairie Lakes Health Care System
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
University of Tennessee Medical Center - Cancer Institute
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37885
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5505
Country
United States
Facility Name
Local Institution - 114
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Brooke Army Medical Center Francis Street Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78235-8200
Country
United States
Facility Name
Local Institution - 103
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78235-8200
Country
United States
Facility Name
Local Institution - 130
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Northwest Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Utah Cancer Specialist
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Swedish Cancer Inst
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Medical Oncology Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Wenatchee Valley Hospital and Clinics
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Local Institution - 139
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
25606
Country
United States
Facility Name
West Virginia University CTRU
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
25606
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Local Institution - 136
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Hospital St. Polten
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Local Institution - 523
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Local Institution - 480
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 481
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Wilhelminenspital-Center for Hematology and Oncology
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Name
Local Institution - 308
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
RSM Durham Regional Cancer Center - Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
CSSS Champlain Charles LeMoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Local Institution - 301
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre De Sante Et De Services Sociaux De Rimouski-Neigette
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L5T1
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Local Institution - 307
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H5N4
Country
Canada
Facility Name
Local Institution - 304
City
Halifax
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution - 447
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Copenhagen University Hospital Rigshosptalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution - 506
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution - 400
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
DK-5000
Country
Denmark
Facility Name
Local Institution - 499
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
290
Country
Finland
Facility Name
Local Institution - 455
City
Helsinki
ZIP/Postal Code
290
Country
Finland
Facility Name
Hyvinkaa Hospital
City
Hyvinkaa
ZIP/Postal Code
05850
Country
Finland
Facility Name
Local Institution - 510
City
Hyvinkaa
ZIP/Postal Code
05850
Country
Finland
Facility Name
Centre Hospitalier de la cote basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Local Institution - 469
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Centre Hospitalier William Morey
City
Chalon sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
Local Institution - 498
City
Chalon sur Saone
ZIP/Postal Code
71100
Country
France
Facility Name
CHU Hotel
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution - 483
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
GH Institut Catholique St Vincent
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHRU de Lille-Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 476
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU Hotel Dieu
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Local Institution - 486
City
Nantes
ZIP/Postal Code
44035
Country
France
Facility Name
Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution - 497
City
Pierre-Bénite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
CHU La Miletrie
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution - 516
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
CHRU Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution - 504
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
City
Toulouse Cedex
ZIP/Postal Code
31052
Country
France
Facility Name
CHRU Hopital Bretonneau
City
Tours cedex
ZIP/Postal Code
37044
Country
France
Facility Name
Local Institution - 468
City
Tours cedex
ZIP/Postal Code
37044
Country
France
Facility Name
ChariteUniversitatsmedizinCampus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Local Institution - 442
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Local Institution - 417
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 475
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitaetsklinikum EssenInnere Klinik und Poliklinik
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 496
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Local Institution - 430
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution - 410
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
UKT Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
General Hospital of Athens Evangelismos
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Local Institution - 484
City
Athens
ZIP/Postal Code
10676
Country
Greece
Facility Name
Local Institution - 422
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
University of Athens Medical school - Regional General Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Local Institution - 487
City
Mezourlo
ZIP/Postal Code
41110
Country
Greece
Facility Name
University General Hospital of Larissa
City
Mezourlo
ZIP/Postal Code
41110
Country
Greece
Facility Name
George Papanikolaou General Hospital of Thessaloniki
City
Thessloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Local Institution - 465
City
Thessloniki
ZIP/Postal Code
57010
Country
Greece
Facility Name
Local Institution - 462
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
Local Institution - 431
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
St James Hospital
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
Local Institution - 413
City
Galway
ZIP/Postal Code
ST46QG
Country
Ireland
Facility Name
University College Hospital Galway
City
Galway
ZIP/Postal Code
ST46QG
Country
Ireland
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 457
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution - 433
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center Department of Hematology
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution - 449
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution - 456
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Policlinico S. Orsola - Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution - 415
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Ospedale Ferrarotto
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Local Institution - 403
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
University of Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution - 451
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Local Institution - 441
City
Pescara
ZIP/Postal Code
65124
Country
Italy
Facility Name
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution - 414
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
La Sapienza, University of Rome
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 460
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
Local Institution - 459
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Local Institution - 453
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Azienda Ospedaliera S Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution - 402
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Azienda Ospedaliera San Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 401
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Hitachi General Hospital
City
Hitachi, Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Local Institution - 620
City
Hitachi, Ibaraki
ZIP/Postal Code
317-0077
Country
Japan
Facility Name
Kameda Medical Center
City
Kamogawa
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Local Institution - 625
City
Kamogawa
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
Local Institution - 626
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Okayama Medical Center
City
Okayama
ZIP/Postal Code
701-1192
Country
Japan
Facility Name
Japan Red Cross Medical Center
City
Shibuya-ku
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Local Institution - 623
City
Shibuya-ku
ZIP/Postal Code
150-8935
Country
Japan
Facility Name
Local Institution - 622
City
Tachikawa
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
National Hospital Organization Disaster Medical Center
City
Tachikawa
ZIP/Postal Code
190-0014
Country
Japan
Facility Name
Local Institution - 514
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
Local Institution - 494
City
Rotterdam
ZIP/Postal Code
3015 CN
Country
Netherlands
Facility Name
Local Institution - 412
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
Oslo universitetssykehus, Rikshospitalet
City
Oslo
ZIP/Postal Code
0372
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Local Institution - 411
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Szpital Specjalistyczny w Brzozowie
City
Brzozow
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 407
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Zespol Szpitali Miejskich
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Klinika Hematologii Akademii Medycznej w Gdansku
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution - 463
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Local Institution - 440
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Oddzial Kliniczny Kliniki Hematologii
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Kopernik Memorial Hospital
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Local Institution - 418
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Klinika Hematoonkologii i Transplantacji Szpiku
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Local Institution - 439
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Local Institution - 437
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 448
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Local Institution - 450
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Local Institution - 454
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Local Institution - 466
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Fundacao Champalimaud
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Local Institution - 473
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Local Institution - 464
City
Porto
ZIP/Postal Code
0
Country
Portugal
Facility Name
Instituto Portugues de Oncologia do Porto, Francisco Gentil
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Local Institution - 425
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Hospital de Santo Antonio- Porto
City
Porto
Country
Portugal
Facility Name
Ad-Vance Medical Research, LLC
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
City Clinical Hospital 52
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Local Institution - 521
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Local Institution - 517
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Local Institution - 520
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Nizhniy Novgorod Region
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias i Pujol Can Ruti
City
Badalona (Barcelona)
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution - 423
City
Badalona (Barcelona)
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution - 424
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de Basurto-Osakidetza
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 452
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Local Institution - 502
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Complejo Hospitalario De Orense
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Local Institution - 526
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 434
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario Nuestra Senora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Local Institution - 492
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Falu lasarett
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Local Institution - 426
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Local Institution - 478
City
Gothenburg
ZIP/Postal Code
60 Gothenburg
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
60 Gothenburg
Country
Sweden
Facility Name
Local Institution - 429
City
Luleå
ZIP/Postal Code
SE-971 80
Country
Sweden
Facility Name
Sunderby Sjukhus
City
Luleå
ZIP/Postal Code
SE-971 80
Country
Sweden
Facility Name
Karolinska University
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Local Institution - 471
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Sundsvalls sjukhus- Medicinkliniken
City
Sundsvall
ZIP/Postal Code
S-85643
Country
Sweden
Facility Name
Ankara University Medical Faculty Cebeci Hospital
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Local Institution - 428
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Gazi Universitesi Tip Fakultesi Hastanesi
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Facility Name
Local Institution - 409
City
Ankara
ZIP/Postal Code
6500
Country
Turkey
Facility Name
Ankara Universitesi Tip Fakultesi
City
Ankara
ZIP/Postal Code
Dikimevi Cebeci
Country
Turkey
Facility Name
Local Institution - 408
City
Ankara
ZIP/Postal Code
Dikimevi Cebeci
Country
Turkey
Facility Name
Local Institution - 488
City
Antalya
ZIP/Postal Code
07050
Country
Turkey
Facility Name
Medstar Antalya Hospital
City
Antalya
ZIP/Postal Code
07050
Country
Turkey
Facility Name
Eskisehir Osmangazi University
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Local Institution - 420
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Facility Name
Local Institution - 421
City
Gaziantep
ZIP/Postal Code
0
Country
Turkey
Facility Name
Gaziantep University
City
Gaziantep
Country
Turkey
Facility Name
Istanbul Universitesi Cerrahpasa Tip Fakultesi
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Local Institution - 445
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul University Faculty of Medicine
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Local Institution - 474
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Ege University Medical School
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution - 419
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Local Institution - 404
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
The Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Kent and Canterbury Hospital
City
Canterbury Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Local Institution - 479
City
Canterbury Kent
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Local Institution - 406
City
Edinburgh Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Local Institution - 490
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution - 461
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution - 512
City
Oxford
ZIP/Postal Code
OX3 7DQ
Country
United Kingdom
Facility Name
University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7DQ
Country
United Kingdom
Facility Name
Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Local Institution - 515
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Local Institution - 500
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Local Institution - 493
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire Nhs Trust - City General Hospital
City
Stoke-On-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Local Institution - 405
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom
Facility Name
Local Institution - 482
City
Wolverhampton
ZIP/Postal Code
WV10 OPQ
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
ZIP/Postal Code
WV10 OPQ
Country
United Kingdom
Facility Name
Local Institution - 436
City
Worcester
ZIP/Postal Code
WR5 1DD
Country
United Kingdom
Facility Name
Worcestershire Acute Hospitals NHS Trust
City
Worcester
ZIP/Postal Code
WR5 1DD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31097405
Citation
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.
Results Reference
derived
PubMed Identifier
28642620
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

We'll reach out to this number within 24 hrs