Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

559

Study ID:

NCT01734928

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 197 Locations for this study

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Southern Cancer Center
Mobile Alabama, 36608, United States
Arizona Oncology
Tucson Arizona, 85710, United States
University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Alta Bates Comprehensive Cancer Center
Berkeley California, 94704, United States
University of California San Francisco Fresno Campus
Fresno California, 93701, United States
Marin Oncology Associates
Greenbrae California, 94904, United States
Moore UCSD Cancer Center
La Jolla California, 92083, United States
USC Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Sutter Pacific Medical Foundation
Santa Rosa California, 95403, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Cancer Center of Central Connecticut
Southington Connecticut, 06489, United States
Local Institution - 153
Southington Connecticut, 06489, United States
George Washington Medical Center
Washington District of Columbia, 20037, United States
Lynn Cancer Institute
Boca Raton Florida, 33486, United States
University Cancer Institute
Boynton Beach Florida, 33426, United States
Broward Oncology Associates PA
Fort Lauderdale Florida, 33308, United States
Broward Oncology Assoc.
Fort Lauderdale Florida, 33316, United States
University of Florida
Gainesville Florida, 32610, United States
Alves Domenech Oncology and Hematology Clinic
Hollywood Florida, 33021, United States
Palm Beach Cancer Institute, LLC
West Palm Beach Florida, 33401, United States
Local Institution - 135
Marietta Georgia, 30060, United States
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute
Marietta Georgia, 30060, United States
University of Chicago
Chicago Illinois, 60637, United States
Investigative Clinical Research of Indiana, LLC
Indianapolis Indiana, 46254, United States
University of Iowa
Iowa City Iowa, 52242, United States
Western Kentucky Hematology and Oncology Group, PSC
Paducah Kentucky, 42003, United States
Tulane University Medical Center
New Orleans Louisiana, 70112, United States
Cancer Care of Maine
Bangor Maine, 04401, United States
Local Institution - 132
Bangor Maine, 04401, United States
St. Agnes - Medical Center
Baltimore Maryland, 21229, United States
Center for Cancer and Blood Disorders
Bethesda Maryland, 20817, United States
Local Institution - 125
Bethesda Maryland, 20817, United States
Medstar Health Research Institute
Hyattsville Maryland, 20782, United States
Local Institution - 299
Boston Massachusetts, 02114, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Local Institution - 100
Boston Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Local Institution - 298
Boston Massachusetts, 02215, United States
Henry Ford Medical Center - New Center One
Detroit Michigan, 48202, United States
Local Institution - 178
Detroit Michigan, 48202, United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids Michigan, 49546, United States
Detroit Clinical Research Center
Lansing Michigan, 48912, United States
Beaumont Cancer Center
Royal Oak Michigan, 48073, United States
Essentia Health Duluth CCOP
Duluth Minnesota, 55805, United States
Metro MN CCOP
Saint Louis Park Minnesota, 55416, United States
Columbia Comprehensive
Jefferson City Missouri, 65203, United States
Kansas City VA Medical Center University of Kansas Medical Center
Kansas City Missouri, 64128, United States
St John's Mercy Medical Center
Saint Louis Missouri, 63141, United States
St. John's Clinic Cancerand Hematology - Springfield
Springfield Missouri, 65804, United States
Billings Clinic
Billings Montana, 59102, United States
Southeast Nebraska Cancer Center
Lincoln Nebraska, 68510, United States
CarePoint Health Research Institute
Jersey City New Jersey, 07306, United States
Hematology-Oncology Associates of NNJ, P
Morristown New Jersey, 07960, United States
Somerset Hematology-Oncology Associates
Somerville New Jersey, 08876, United States
Local Institution - 186
Bronx New York, 10467, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Mount Sinai Hospital
New York New York, 10029, United States
Stony Brook University
Stony Brook New York, 11794, United States
New York Medical College
Valhalla New York, 10595, United States
Eastern Institute of Medical Sciences
Greenville North Carolina, 27834, United States
Boice-Willis Clinic P.A.
Rocky Mount North Carolina, 27804, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Local Institution - 111
Canton Ohio, 44718, United States
MetroHealth Medical Systems
Cleveland Ohio, 44109, United States
Mid Ohio Oncology Hematology Inc
Columbus Ohio, 43219, United States
University of Toledo Medical Center
Toledo Ohio, 43614, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Med Univ of South Carolina
Charleston South Carolina, 29425, United States
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Spartanburg South Carolina, 29303, United States
Avera Research Institute
Sioux Falls South Dakota, 57105, United States
Local Institution - 167
Watertown South Dakota, 57201, United States
Prairie Lakes Health Care System
Watertown South Dakota, 57201, United States
University of Tennessee Medical Center - Cancer Institute
Knoxville Tennessee, 37885, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Local Institution - 114
Dallas Texas, 75390, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
Brooke Army Medical Center Francis Street Medical Center
Fort Sam Houston Texas, 78235, United States
Local Institution - 103
Fort Sam Houston Texas, 78235, United States
Local Institution - 130
Houston Texas, 77090, United States
Northwest Cancer Center
Houston Texas, 77090, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock Texas, 79410, United States
Utah Cancer Specialist
Salt Lake City Utah, 84106, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City Utah, 84112, United States
Swedish Cancer Inst
Seattle Washington, 98104, United States
Medical Oncology Associates
Spokane Washington, 99208, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States
Local Institution - 139
Morgantown West Virginia, 25606, United States
West Virginia University CTRU
Morgantown West Virginia, 25606, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Local Institution - 136
Milwaukee Wisconsin, 53226, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Hospital St. Polten
St. Pölten , 3100, Austria
Local Institution - 523
St. Pölten , 3100, Austria
Local Institution - 480
Vienna , 1090, Austria
Medical University of Vienna
Vienna , 1090, Austria
Local Institution - 481
Vienna , 1160, Austria
Wilhelminenspital-Center for Hematology and Oncology
Vienna , 1160, Austria
RSM Durham Regional Cancer Center - Lakeridge Health Oshawa
Oshawa Ontario, L1G 2, Canada
CSSS Champlain Charles LeMoyne
Greenfield Park Quebec, J4V 2, Canada
Local Institution - 301
Greenfield Park Quebec, J4V 2, Canada
Centre De Sante Et De Services Sociaux De Rimouski-Neigette
Rimouski Quebec, G5L5T, Canada
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont
Sherbrooke Quebec, J1H5N, Canada
Local Institution - 307
Sherbrooke Quebec, J1H5N, Canada
Local Institution - 304
Halifax , B3H 2, Canada
Queen Elizabeth II Health Sciences Centre
Halifax , B3H 2, Canada
Aarhus University Hospital
Aarhus , 8000, Denmark
Copenhagen University Hospital Rigshosptalet
Copenhagen , 2100, Denmark
Odense University Hospital
Odense , DK-50, Denmark
Local Institution - 499
Vejle , 7100, Denmark
Vejle Hospital
Vejle , 7100, Denmark
Helsinki University Central Hospital
Helsinki , 290, Finland
Local Institution - 455
Helsinki , 290, Finland
Hyvinkaa Hospital
Hyvinkaa , 05850, Finland
Centre Hospitalier de la cote basque
Bayonne , 64109, France
Centre Hospitalier William Morey
Chalon sur Saone , 71100, France
CHU Hotel
Grenoble Cedex 09 , 38043, France
GH Institut Catholique St Vincent
Lille , 59000, France
CHRU de Lille-Hopital Claude Huriez
Lille , 59037, France
Local Institution - 476
Lille , 59037, France
CHRU Hotel Dieu
Nantes , 44035, France
Local Institution - 486
Nantes , 44035, France
Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine
Paris , 75012, France
Centre Hospitalier Lyon Sud
Pierre-Bénite Cedex , 69495, France
CHU La Miletrie
Poitiers Cedex , 86021, France
Local Institution - 516
Poitiers Cedex , 86021, France
CHRU Rennes
Rennes , 35033, France
Local Institution - 504
Rennes , 35033, France
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole
Toulouse Cedex , 31052, France
CHRU Hopital Bretonneau
Tours cedex , 37044, France
Local Institution - 468
Tours cedex , 37044, France
ChariteUniversitatsmedizinCampus Benjamin Franklin
Berlin , D-133, Germany
Local Institution - 442
Berlin , D-133, Germany
Local Institution - 417
Dresden , 01307, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Local Institution - 475
Essen , 45147, Germany
Universitaetsklinikum EssenInnere Klinik und Poliklinik
Essen , 45147, Germany
Local Institution - 496
Freiburg , 79106, Germany
Universitatsklinikum Freiburg
Freiburg , 79106, Germany
University of Heidelberg
Heidelberg , 69120, Germany
Local Institution - 410
Tuebingen , 72076, Germany
UKT Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
General Hospital of Athens Evangelismos
Athens , 10676, Greece
Local Institution - 422
Athens , 11528, Greece
University of Athens Medical school - Regional General Hospital
Athens , 11528, Greece
Local Institution - 487
Mezourlo , 41110, Greece
University General Hospital of Larissa
Mezourlo , 41110, Greece
George Papanikolaou General Hospital of Thessaloniki
Thessloniki , 57010, Greece
Local Institution - 465
Thessloniki , 57010, Greece
Local Institution - 462
Dublin , Dubli, Ireland
Mater Misericordiae University Hospital
Dublin , Dubli, Ireland
Local Institution - 431
Dublin , Dubli, Ireland
St James Hospital
Dublin , Dubli, Ireland
Local Institution - 413
Galway , ST46Q, Ireland
University College Hospital Galway
Galway , ST46Q, Ireland
Rambam Health Care Campus
Haifa , 31096, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Local Institution - 457
Jerusalem , 91120, Israel
Meir Medical Center
Kfar-Saba , 44281, Israel
Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
Tel Aviv Sourasky Medical Center Department of Hematology
Tel Aviv , 64239, Israel
Local Institution - 449
Bergamo , 24127, Italy
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII
Bergamo , 24127, Italy
Local Institution - 456
Bologna , 40138, Italy
Policlinico S. Orsola - Malpighi
Bologna , 40138, Italy
Ospedale Ferrarotto
Catania , 95124, Italy
University of Modena
Modena , 41100, Italy
IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Local Institution - 451
Pavia , 27100, Italy
Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara
Pescara , 65124, Italy
Local Institution - 441
Pescara , 65124, Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia , 42100, Italy
Local Institution - 414
Reggio Emilia , 42100, Italy
La Sapienza, University of Rome
Rome , 00161, Italy
Local Institution - 460
Rome , 00161, Italy
A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC
Salerno , 84131, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo , 71013, Italy
Azienda Ospedaliera S Maria di Terni
Terni , 05100, Italy
Local Institution - 402
Terni , 05100, Italy
Azienda Ospedaliera San Giovanni Battista
Torino , 10126, Italy
Local Institution - 401
Torino , 10126, Italy
Hitachi General Hospital
Hitachi, Ibaraki , 317-0, Japan
Kameda Medical Center
Kamogawa , 296-8, Japan
Local Institution - 625
Kamogawa , 296-8, Japan
Local Institution - 626
Okayama , 701-1, Japan
Okayama Medical Center
Okayama , 701-1, Japan
Japan Red Cross Medical Center
Shibuya-ku , 150-8, Japan
Local Institution - 623
Shibuya-ku , 150-8, Japan
National Hospital Organization Disaster Medical Center
Tachikawa , 190-0, Japan
Universitair Medisch Centrum Groningen
Groningen , 9713 , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden , 8934 , Netherlands
Erasmus Medical Center
Rotterdam , 3015 , Netherlands
Local Institution - 494
Rotterdam , 3015 , Netherlands
Local Institution - 412
Oslo , 0372, Norway
Oslo universitetssykehus, Rikshospitalet
Oslo , 0372, Norway
St Olavs Hospital
Trondheim , 7006, Norway
Szpital Specjalistyczny w Brzozowie
Brzozow , 36-20, Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela
Bydgoszcz , 85-16, Poland
Zespol Szpitali Miejskich
Chorzow , 41-50, Poland
Klinika Hematologii Akademii Medycznej w Gdansku
Gdansk , 80-95, Poland
Oddzial Kliniczny Kliniki Hematologii
Krakow , 31-50, Poland
Kopernik Memorial Hospital
Lodz , 93-51, Poland
Local Institution - 418
Lodz , 93-51, Poland
Klinika Hematoonkologii i Transplantacji Szpiku
Lublin , 20-08, Poland
Local Institution - 439
Lublin , 20-08, Poland
Local Institution - 437
Poznan , 60-56, Poland
Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
Poznan , 60-56, Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie
Warszawa , 02-78, Poland
Local Institution - 448
Warszawa , 02-78, Poland
Hospital de Braga
Braga , 4710-, Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil
Lisboa , 1099-, Portugal
Hospital de Santa Maria
Lisboa , 1649-, Portugal
Fundacao Champalimaud
Lisbon , 1400-, Portugal
Local Institution - 473
Lisbon , 1400-, Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil
Porto , 4200-, Portugal
Hospital de Santo Antonio- Porto
Porto , , Portugal
Ad-Vance Medical Research, LLC
Ponce , 00717, Puerto Rico
City Clinical Hospital 52
Moscow , 12318, Russian Federation
Local Institution - 517
Moscow , 12528, Russian Federation
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin
Moscow , 12528, Russian Federation
State Budgetary Healthcare Institution of Nizhniy Novgorod Region
Nizhny Novgorod , 60312, Russian Federation
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency
Saint Petersburg , 19102, Russian Federation
Hospital Universitari Germans Trias i Pujol Can Ruti
Badalona (Barcelona) , 08916, Spain
Local Institution - 423
Badalona (Barcelona) , 08916, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Local Institution - 424
Barcelona , 08036, Spain
Hospital de Basurto-Osakidetza
Bilbao , 48013, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Morales Meseguer
Murcia , 30008, Spain
Local Institution - 502
Murcia , 30008, Spain
Complejo Hospitalario De Orense
Orense , 32005, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Complejo Hospitalario Nuestra Senora de Valme
Sevilla , 41014, Spain
Hospital Universitario y Politecnico La Fe
Valencia , 46026, Spain
Falu lasarett
Falun , 79182, Sweden
Local Institution - 426
Falun , 79182, Sweden
Sahlgrenska University Hospital
Gothenburg , 60 Go, Sweden
Local Institution - 429
Luleå , SE-97, Sweden
Sunderby Sjukhus
Luleå , SE-97, Sweden
Karolinska University
Stockholm , 14186, Sweden
Local Institution - 471
Stockholm , 14186, Sweden
Sundsvalls sjukhus- Medicinkliniken
Sundsvall , S-856, Sweden
Ankara University Medical Faculty Cebeci Hospital
Ankara , 06590, Turkey
Local Institution - 428
Ankara , 06590, Turkey
Gazi Universitesi Tip Fakultesi Hastanesi
Ankara , 6500, Turkey
Local Institution - 409
Ankara , 6500, Turkey
Ankara Universitesi Tip Fakultesi
Ankara , Dikim, Turkey
Local Institution - 408
Ankara , Dikim, Turkey
Medstar Antalya Hospital
Antalya , 07050, Turkey
Eskisehir Osmangazi University
Eskisehir , 26480, Turkey
Local Institution - 421
Gaziantep , 0, Turkey
Gaziantep University
Gaziantep , , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul , 34098, Turkey
Istanbul University Faculty of Medicine
Istanbul , 34390, Turkey
Local Institution - 474
Istanbul , 34390, Turkey
Ege University Medical School
Izmir , 35100, Turkey
Local Institution - 419
Izmir , 35100, Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi
Trabzon , 61080, Turkey
The Royal Bournemouth Hospital
Bournemouth , BH7 7, United Kingdom
Kent and Canterbury Hospital
Canterbury Kent , CT1 3, United Kingdom
Local Institution - 479
Canterbury Kent , CT1 3, United Kingdom
Local Institution - 406
Edinburgh Scotland , EH4 2, United Kingdom
Western General Hospital
Edinburgh Scotland , EH4 2, United Kingdom
Local Institution - 490
London , NW1 2, United Kingdom
University College London Hospitals
London , NW1 2, United Kingdom
Kings College Hospital
London , SE5 9, United Kingdom
Local Institution - 512
Oxford , OX3 7, United Kingdom
University of Oxford
Oxford , OX3 7, United Kingdom
Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit
Plymouth , PL6 8, United Kingdom
Local Institution - 515
Plymouth , PL6 8, United Kingdom
Local Institution - 500
Sheffield , S10 2, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital
Sheffield , S10 2, United Kingdom
Local Institution - 493
Southampton , SO16 , United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom
University Hospital of North Staffordshire Nhs Trust - City General Hospital
Stoke-On-Trent , ST4 6, United Kingdom
Singleton Hospital
Swansea , SA2 8, United Kingdom
Local Institution - 482
Wolverhampton , WV10 , United Kingdom
New Cross Hospital
Wolverhampton , WV10 , United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester , WR5 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 3

Estimated Enrollment:

559

Study ID:

NCT01734928

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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