Clinical trial NCT01734928: Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Pomalidomide
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 559
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression Free Survival by Independent Response Adjudication Committee (IRAC)
timeFrame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization to date of death, up to approximately 65 months
measure: Overall Response Rate by Independent Response Adjudication Committee (IRAC)
timeFrame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
measure: Duration of Response by Independent Response Adjudication Committee (IRAC)
timeFrame: From randomization to progressive disease or death during the IRAC assessment period, up to approximately 42 months
measure: Number of Participants With Grade 3-4 Treatment Emergent Adverse Events (TEAE)
timeFrame: From first dose to 28 days after the last dose (up to approximately 44 months
measure: Number of Participants With Grade 5 Treatment Emergent Adverse Events (TEAE)
timeFrame: From first dose to 28 days after the last dose (up to approximately 44 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Fresno
country: United States
facility: University of California San Francisco Fresno Campus
state: California
city: Greenbrae
country: United States
facility: Marin Oncology Associates
state: California
city: La Jolla
country: United States
facility: Moore UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: Santa Rosa
country: United States
facility: Sutter Pacific Medical Foundation
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Southington
country: United States
facility: Local Institution - 153
state: Connecticut
city: Washington
country: United States
facility: George Washington Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: Lynn Cancer Institute
state: Florida
city: Boynton Beach
country: United States
facility: University Cancer Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates PA
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Oncology Assoc.
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Alves Domenech Oncology and Hematology Clinic
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute, LLC
state: Florida
city: Marietta
country: United States
facility: Local Institution - 135
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Investigative Clinical Research of Indiana, LLC
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Paducah
country: United States
facility: Western Kentucky Hematology and Oncology Group, PSC
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
city: Bangor
country: United States
facility: Cancer Care of Maine
state: Maine
city: Bangor
country: United States
facility: Local Institution - 132
state: Maine
city: Baltimore
country: United States
facility: St. Agnes - Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders
state: Maryland
city: Bethesda
country: United States
facility: Local Institution - 125
state: Maryland
city: Hyattsville
country: United States
facility: Medstar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Local Institution - 299
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 100
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Local Institution - 298
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Medical Center - New Center One
state: Michigan
city: Detroit
country: United States
facility: Local Institution - 178
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Lansing
country: United States
facility: Detroit Clinical Research Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Cancer Center
state: Michigan
city: Duluth
country: United States
facility: Essentia Health Duluth CCOP
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro MN CCOP
state: Minnesota
city: Jefferson City
country: United States
facility: Columbia Comprehensive
state: Missouri
city: Kansas City
country: United States
facility: Kansas City VA Medical Center University of Kansas Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: St John's Mercy Medical Center
state: Missouri
city: Springfield
country: United States
facility: St. John's Clinic Cancerand Hematology - Springfield
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Jersey City
country: United States
facility: CarePoint Health Research Institute
state: New Jersey
city: Morristown
country: United States
facility: Hematology-Oncology Associates of NNJ, P
state: New Jersey
city: Somerville
country: United States
facility: Somerset Hematology-Oncology Associates
state: New Jersey
city: Bronx
country: United States
facility: Local Institution - 186
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Greenville
country: United States
facility: Eastern Institute of Medical Sciences
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic P.A.
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Canton
country: United States
facility: Local Institution - 111
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Systems
state: Ohio
city: Columbus
country: United States
facility: Mid Ohio Oncology Hematology Inc
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Charleston
country: United States
facility: Med Univ of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Watertown
country: United States
facility: Local Institution - 167
state: South Dakota
city: Watertown
country: United States
facility: Prairie Lakes Health Care System
state: South Dakota
city: Knoxville
country: United States
facility: University of Tennessee Medical Center - Cancer Institute
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Local Institution - 114
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center Francis Street Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Local Institution - 103
state: Texas
city: Houston
country: United States
facility: Local Institution - 130
state: Texas
city: Houston
country: United States
facility: Northwest Cancer Center
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialist
state: Utah
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Seattle
country: United States
facility: Swedish Cancer Inst
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital and Clinics
state: Washington
city: Morgantown
country: United States
facility: Local Institution - 139
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University CTRU
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Local Institution - 136
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: St. Pölten
country: Austria
facility: Hospital St. Polten
city: St. Pölten
country: Austria
facility: Local Institution - 523
city: Vienna
country: Austria
facility: Local Institution - 480
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Local Institution - 481
city: Vienna
country: Austria
facility: Wilhelminenspital-Center for Hematology and Oncology
city: Oshawa
country: Canada
facility: Local Institution - 308
state: Ontario
city: Oshawa
country: Canada
facility: RSM Durham Regional Cancer Center - Lakeridge Health Oshawa
state: Ontario
city: Greenfield Park
country: Canada
facility: CSSS Champlain Charles LeMoyne
state: Quebec
city: Greenfield Park
country: Canada
facility: Local Institution - 301
state: Quebec
city: Rimouski
country: Canada
facility: Centre De Sante Et De Services Sociaux De Rimouski-Neigette
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
state: Quebec
city: Sherbrooke
country: Canada
facility: Local Institution - 307
state: Quebec
city: Halifax
country: Canada
facility: Local Institution - 304
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Local Institution - 447
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshosptalet
city: Copenhagen
country: Denmark
facility: Local Institution - 506
city: Odense
country: Denmark
facility: Local Institution - 400
city: Odense
country: Denmark
facility: Odense University Hospital
city: Vejle
country: Denmark
facility: Local Institution - 499
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Helsinki
country: Finland
facility: Local Institution - 455
city: Hyvinkaa
country: Finland
facility: Hyvinkaa Hospital
city: Hyvinkaa
country: Finland
facility: Local Institution - 510
city: Bayonne
country: France
facility: Centre Hospitalier de la cote basque
city: Bayonne
country: France
facility: Local Institution - 469
city: Chalon sur Saone
country: France
facility: Centre Hospitalier William Morey
city: Chalon sur Saone
country: France
facility: Local Institution - 498
city: Grenoble Cedex 09
country: France
facility: CHU Hotel
city: Grenoble Cedex 09
country: France
facility: Local Institution - 483
city: Lille
country: France
facility: GH Institut Catholique St Vincent
city: Lille
country: France
facility: CHRU de Lille-Hopital Claude Huriez
city: Lille
country: France
facility: Local Institution - 476
city: Nantes
country: France
facility: CHRU Hotel Dieu
city: Nantes
country: France
facility: Local Institution - 486
city: Paris
country: France
facility: Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine
city: Pierre-Bénite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Pierre-Bénite Cedex
country: France
facility: Local Institution - 497
city: Poitiers Cedex
country: France
facility: CHU La Miletrie
city: Poitiers Cedex
country: France
facility: Local Institution - 516
city: Rennes
country: France
facility: CHRU Rennes
city: Rennes
country: France
facility: Local Institution - 504
city: Toulouse Cedex
country: France
facility: Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
city: Tours cedex
country: France
facility: CHRU Hopital Bretonneau
city: Tours cedex
country: France
facility: Local Institution - 468
city: Berlin
country: Germany
facility: ChariteUniversitatsmedizinCampus Benjamin Franklin
city: Berlin
country: Germany
facility: Local Institution - 442
city: Dresden
country: Germany
facility: Local Institution - 417
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Local Institution - 475
city: Essen
country: Germany
facility: Universitaetsklinikum EssenInnere Klinik und Poliklinik
city: Freiburg
country: Germany
facility: Local Institution - 496
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Heidelberg
country: Germany
facility: Local Institution - 430
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Tuebingen
country: Germany
facility: Local Institution - 410
city: Tuebingen
country: Germany
facility: UKT Universitaetsklinikum Tuebingen
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos
city: Athens
country: Greece
facility: Local Institution - 484
city: Athens
country: Greece
facility: Local Institution - 422
city: Athens
country: Greece
facility: University of Athens Medical school - Regional General Hospital
city: Mezourlo
country: Greece
facility: Local Institution - 487
city: Mezourlo
country: Greece
facility: University General Hospital of Larissa
city: Thessloniki
country: Greece
facility: George Papanikolaou General Hospital of Thessaloniki
city: Thessloniki
country: Greece
facility: Local Institution - 465
city: Dublin
country: Ireland
facility: Local Institution - 462
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Dublin
country: Ireland
facility: Local Institution - 431
city: Dublin
country: Ireland
facility: St James Hospital
city: Galway
country: Ireland
facility: Local Institution - 413
city: Galway
country: Ireland
facility: University College Hospital Galway
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Jerusalem
country: Israel
facility: Local Institution - 457
city: Kfar-Saba
country: Israel
facility: Local Institution - 433
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center Department of Hematology
city: Bergamo
country: Italy
facility: Local Institution - 449
city: Bergamo
country: Italy
facility: USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
city: Bologna
country: Italy
facility: Local Institution - 456
city: Bologna
country: Italy
facility: Policlinico S. Orsola - Malpighi
city: Catania
country: Italy
facility: Local Institution - 415
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Modena
country: Italy
facility: Local Institution - 403
city: Modena
country: Italy
facility: University of Modena
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
city: Pavia
country: Italy
facility: Local Institution - 451
city: Pescara
country: Italy
facility: Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara
city: Pescara
country: Italy
facility: Local Institution - 441
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
city: Reggio Emilia
country: Italy
facility: Local Institution - 414
city: Rome
country: Italy
facility: La Sapienza, University of Rome
city: Rome
country: Italy
facility: Local Institution - 460
city: Salerno
country: Italy
facility: A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
city: Salerno
country: Italy
facility: Local Institution - 459
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
city: San Giovanni Rotondo
country: Italy
facility: Local Institution - 453
city: Terni
country: Italy
facility: Azienda Ospedaliera S Maria di Terni
city: Terni
country: Italy
facility: Local Institution - 402
city: Torino
country: Italy
facility: Azienda Ospedaliera San Giovanni Battista
city: Torino
country: Italy
facility: Local Institution - 401
city: Hitachi, Ibaraki
country: Japan
facility: Hitachi General Hospital
city: Hitachi, Ibaraki
country: Japan
facility: Local Institution - 620
city: Kamogawa
country: Japan
facility: Kameda Medical Center
city: Kamogawa
country: Japan
facility: Local Institution - 625
city: Okayama
country: Japan
facility: Local Institution - 626
city: Okayama
country: Japan
facility: Okayama Medical Center
city: Shibuya-ku
country: Japan
facility: Japan Red Cross Medical Center
city: Shibuya-ku
country: Japan
facility: Local Institution - 623
city: Tachikawa
country: Japan
facility: Local Institution - 622
city: Tachikawa
country: Japan
facility: National Hospital Organization Disaster Medical Center
city: Groningen
country: Netherlands
facility: Local Institution - 514
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Rotterdam
country: Netherlands
facility: Local Institution - 494
city: Oslo
country: Norway
facility: Local Institution - 412
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Rikshospitalet
city: Trondheim
country: Norway
facility: St Olavs Hospital
city: Brzozow
country: Poland
facility: Local Institution - 411
city: Brzozow
country: Poland
facility: Szpital Specjalistyczny w Brzozowie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr. Jana Biziela
city: Chorzow
country: Poland
facility: Local Institution - 407
city: Chorzow
country: Poland
facility: Zespol Szpitali Miejskich
city: Gdansk
country: Poland
facility: Klinika Hematologii Akademii Medycznej w Gdansku
city: Gdansk
country: Poland
facility: Local Institution - 463
city: Krakow
country: Poland
facility: Local Institution - 440
city: Krakow
country: Poland
facility: Oddzial Kliniczny Kliniki Hematologii
city: Lodz
country: Poland
facility: Kopernik Memorial Hospital
city: Lodz
country: Poland
facility: Local Institution - 418
city: Lublin
country: Poland
facility: Klinika Hematoonkologii i Transplantacji Szpiku
city: Lublin
country: Poland
facility: Local Institution - 439
city: Poznan
country: Poland
facility: Local Institution - 437
city: Poznan
country: Poland
facility: Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
city: Warszawa
country: Poland
facility: Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
city: Warszawa
country: Poland
facility: Local Institution - 448
city: Braga
country: Portugal
facility: Hospital de Braga
city: Braga
country: Portugal
facility: Local Institution - 450
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
city: Lisboa
country: Portugal
facility: Local Institution - 454
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Local Institution - 466
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud
city: Lisbon
country: Portugal
facility: Local Institution - 473
city: Porto
country: Portugal
facility: Local Institution - 464
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto, Francisco Gentil
city: Porto
country: Portugal
facility: Local Institution - 425
city: Porto
country: Portugal
facility: Hospital de Santo Antonio- Porto
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research, LLC
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 52
city: Moscow
country: Russian Federation
facility: Local Institution - 521
city: Moscow
country: Russian Federation
facility: Local Institution - 517
city: Moscow
country: Russian Federation
facility: Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
city: Nizhny Novgorod
country: Russian Federation
facility: Local Institution - 520
city: Nizhny Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution of Nizhniy Novgorod Region
city: Saint Petersburg
country: Russian Federation
facility: Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
city: Badalona (Barcelona)
country: Spain
facility: Hospital Universitari Germans Trias i Pujol Can Ruti
city: Badalona (Barcelona)
country: Spain
facility: Local Institution - 423
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Local Institution - 424
city: Bilbao
country: Spain
facility: Hospital de Basurto-Osakidetza
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Local Institution - 452
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
city: Murcia
country: Spain
facility: Local Institution - 502
city: Orense
country: Spain
facility: Complejo Hospitalario De Orense
city: Orense
country: Spain
facility: Local Institution - 526
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Pamplona
country: Spain
facility: Local Institution - 434
city: Sevilla
country: Spain
facility: Complejo Hospitalario Nuestra Senora de Valme
city: Sevilla
country: Spain
facility: Local Institution - 492
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Falun
country: Sweden
facility: Falu lasarett
city: Falun
country: Sweden
facility: Local Institution - 426
city: Gothenburg
country: Sweden
facility: Local Institution - 478
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Luleå
country: Sweden
facility: Local Institution - 429
city: Luleå
country: Sweden
facility: Sunderby Sjukhus
city: Stockholm
country: Sweden
facility: Karolinska University
city: Stockholm
country: Sweden
facility: Local Institution - 471
city: Sundsvall
country: Sweden
facility: Sundsvalls sjukhus- Medicinkliniken
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Cebeci Hospital
city: Ankara
country: Turkey
facility: Local Institution - 428
city: Ankara
country: Turkey
facility: Gazi Universitesi Tip Fakultesi Hastanesi
city: Ankara
country: Turkey
facility: Local Institution - 409
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi
city: Ankara
country: Turkey
facility: Local Institution - 408
city: Antalya
country: Turkey
facility: Local Institution - 488
city: Antalya
country: Turkey
facility: Medstar Antalya Hospital
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi University
city: Eskisehir
country: Turkey
facility: Local Institution - 420
city: Gaziantep
country: Turkey
facility: Local Institution - 421
city: Gaziantep
country: Turkey
facility: Gaziantep University
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Istanbul
country: Turkey
facility: Local Institution - 445
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Medicine
city: Istanbul
country: Turkey
facility: Local Institution - 474
city: Izmir
country: Turkey
facility: Ege University Medical School
city: Izmir
country: Turkey
facility: Local Institution - 419
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
city: Trabzon
country: Turkey
facility: Local Institution - 404
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
city: Canterbury Kent
country: United Kingdom
facility: Kent and Canterbury Hospital
city: Canterbury Kent
country: United Kingdom
facility: Local Institution - 479
city: Edinburgh Scotland
country: United Kingdom
facility: Local Institution - 406
city: Edinburgh Scotland
country: United Kingdom
facility: Western General Hospital
city: London
country: United Kingdom
facility: Local Institution - 490
city: London
country: United Kingdom
facility: University College London Hospitals
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Local Institution - 461
city: Oxford
country: United Kingdom
facility: Local Institution - 512
city: Oxford
country: United Kingdom
facility: University of Oxford
city: Plymouth
country: United Kingdom
facility: Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit
city: Plymouth
country: United Kingdom
facility: Local Institution - 515
city: Sheffield
country: United Kingdom
facility: Local Institution - 500
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
city: Southampton
country: United Kingdom
facility: Local Institution - 493
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Stoke-On-Trent
country: United Kingdom
facility: University Hospital of North Staffordshire Nhs Trust - City General Hospital
city: Swansea
country: United Kingdom
facility: Local Institution - 405
city: Swansea
country: United Kingdom
facility: Singleton Hospital
city: Wolverhampton
country: United Kingdom
facility: Local Institution - 482
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
city: Worcester
country: United Kingdom
facility: Local Institution - 436
city: Worcester
country: United Kingdom
facility: Worcestershire Acute Hospitals NHS Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers-Squibb
role: STUDY_DIRECTOR
affiliation: Celgene Corporation
name: Amine Bensmaine, MD
role: STUDY_DIRECTOR
References:
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.
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.