Spots Global Cancer Trial Database for Safety and Efficacy of Pomalidomide, Bortezomib and Low-dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: 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 ID: NCT01734928
Conditions
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Southern Cancer Center, Mobile, Alabama, United States
Arizona Oncology, Tucson, Arizona, United States
University of Arizona Cancer Center, Tucson, Arizona, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
University of California San Francisco Fresno Campus, Fresno, California, United States
Marin Oncology Associates, Greenbrae, California, United States
Moore UCSD Cancer Center, La Jolla, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Sutter Pacific Medical Foundation, Santa Rosa, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Cancer Center of Central Connecticut, Southington, Connecticut, United States
Local Institution - 153, Southington, Connecticut, United States
George Washington Medical Center, Washington, District of Columbia, United States
Lynn Cancer Institute, Boca Raton, Florida, United States
University Cancer Institute, Boynton Beach, Florida, United States
Broward Oncology Associates PA, Fort Lauderdale, Florida, United States
Broward Oncology Assoc., Fort Lauderdale, Florida, United States
University of Florida, Gainesville, Florida, United States
Alves Domenech Oncology and Hematology Clinic, Hollywood, Florida, United States
Palm Beach Cancer Institute, LLC, West Palm Beach, Florida, United States
Local Institution - 135, Marietta, Georgia, United States
Northwest Georgia Oncology Centers, PCWilliam S. Gibbons Center Research Institute, Marietta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States
University of Iowa, Iowa City, Iowa, United States
Western Kentucky Hematology and Oncology Group, PSC, Paducah, Kentucky, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
Cancer Care of Maine, Bangor, Maine, United States
Local Institution - 132, Bangor, Maine, United States
St. Agnes - Medical Center, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Local Institution - 125, Bethesda, Maryland, United States
Medstar Health Research Institute, Hyattsville, Maryland, United States
Local Institution - 299, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Local Institution - 100, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Local Institution - 298, Boston, Massachusetts, United States
Henry Ford Medical Center - New Center One, Detroit, Michigan, United States
Local Institution - 178, Detroit, Michigan, United States
Cancer and Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Detroit Clinical Research Center, Lansing, Michigan, United States
Beaumont Cancer Center, Royal Oak, Michigan, United States
Essentia Health Duluth CCOP, Duluth, Minnesota, United States
Metro MN CCOP, Saint Louis Park, Minnesota, United States
Columbia Comprehensive, Jefferson City, Missouri, United States
Kansas City VA Medical Center University of Kansas Medical Center, Kansas City, Missouri, United States
St John's Mercy Medical Center, Saint Louis, Missouri, United States
St. John's Clinic Cancerand Hematology - Springfield, Springfield, Missouri, United States
Billings Clinic, Billings, Montana, United States
Southeast Nebraska Cancer Center, Lincoln, Nebraska, United States
CarePoint Health Research Institute, Jersey City, New Jersey, United States
Hematology-Oncology Associates of NNJ, P, Morristown, New Jersey, United States
Somerset Hematology-Oncology Associates, Somerville, New Jersey, United States
Local Institution - 186, Bronx, New York, United States
Montefiore Medical Center, Bronx, New York, United States
Mount Sinai Hospital, New York, New York, United States
Stony Brook University, Stony Brook, New York, United States
New York Medical College, Valhalla, New York, United States
Eastern Institute of Medical Sciences, Greenville, North Carolina, United States
Boice-Willis Clinic P.A., Rocky Mount, North Carolina, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Local Institution - 111, Canton, Ohio, United States
MetroHealth Medical Systems, Cleveland, Ohio, United States
Mid Ohio Oncology Hematology Inc, Columbus, Ohio, United States
University of Toledo Medical Center, Toledo, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Med Univ of South Carolina, Charleston, South Carolina, United States
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute, Spartanburg, South Carolina, United States
Avera Research Institute, Sioux Falls, South Dakota, United States
Local Institution - 167, Watertown, South Dakota, United States
Prairie Lakes Health Care System, Watertown, South Dakota, United States
University of Tennessee Medical Center - Cancer Institute, Knoxville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Local Institution - 114, Dallas, Texas, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston, Texas, United States
Local Institution - 103, Fort Sam Houston, Texas, United States
Local Institution - 130, Houston, Texas, United States
Northwest Cancer Center, Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Utah Cancer Specialist, Salt Lake City, Utah, United States
Huntsman Cancer Institute at the University of Utah, Salt Lake City, Utah, United States
Swedish Cancer Inst, Seattle, Washington, United States
Medical Oncology Associates, Spokane, Washington, United States
Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States
Local Institution - 139, Morgantown, West Virginia, United States
West Virginia University CTRU, Morgantown, West Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Local Institution - 136, Milwaukee, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Hospital St. Polten, St. Pölten, , Austria
Local Institution - 523, St. Pölten, , Austria
Local Institution - 480, Vienna, , Austria
Medical University of Vienna, Vienna, , Austria
Local Institution - 481, Vienna, , Austria
Wilhelminenspital-Center for Hematology and Oncology, Vienna, , Austria
Local Institution - 308, Oshawa, Ontario, Canada
RSM Durham Regional Cancer Center - Lakeridge Health Oshawa, Oshawa, Ontario, Canada
CSSS Champlain Charles LeMoyne, Greenfield Park, Quebec, Canada
Local Institution - 301, Greenfield Park, Quebec, Canada
Centre De Sante Et De Services Sociaux De Rimouski-Neigette, Rimouski, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke-Hospital Fleurimont, Sherbrooke, Quebec, Canada
Local Institution - 307, Sherbrooke, Quebec, Canada
Local Institution - 304, Halifax, , Canada
Queen Elizabeth II Health Sciences Centre, Halifax, , Canada
Aarhus University Hospital, Aarhus, , Denmark
Local Institution - 447, Aarhus, , Denmark
Copenhagen University Hospital Rigshosptalet, Copenhagen, , Denmark
Local Institution - 506, Copenhagen, , Denmark
Local Institution - 400, Odense, , Denmark
Odense University Hospital, Odense, , Denmark
Local Institution - 499, Vejle, , Denmark
Vejle Hospital, Vejle, , Denmark
Helsinki University Central Hospital, Helsinki, , Finland
Local Institution - 455, Helsinki, , Finland
Hyvinkaa Hospital, Hyvinkaa, , Finland
Local Institution - 510, Hyvinkaa, , Finland
Centre Hospitalier de la cote basque, Bayonne, , France
Local Institution - 469, Bayonne, , France
Centre Hospitalier William Morey, Chalon sur Saone, , France
Local Institution - 498, Chalon sur Saone, , France
CHU Hotel, Grenoble Cedex 09, , France
Local Institution - 483, Grenoble Cedex 09, , France
GH Institut Catholique St Vincent, Lille, , France
CHRU de Lille-Hopital Claude Huriez, Lille, , France
Local Institution - 476, Lille, , France
CHRU Hotel Dieu, Nantes, , France
Local Institution - 486, Nantes, , France
Groupement Hospitalier Universitaire Est - Hopital Saint-Antoine, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite Cedex, , France
Local Institution - 497, Pierre-Bénite Cedex, , France
CHU La Miletrie, Poitiers Cedex, , France
Local Institution - 516, Poitiers Cedex, , France
CHRU Rennes, Rennes, , France
Local Institution - 504, Rennes, , France
Institut Universitaire du Cancer de Toulouse (IUCT) - Oncopole, Toulouse Cedex, , France
CHRU Hopital Bretonneau, Tours cedex, , France
Local Institution - 468, Tours cedex, , France
ChariteUniversitatsmedizinCampus Benjamin Franklin, Berlin, , Germany
Local Institution - 442, Berlin, , Germany
Local Institution - 417, Dresden, , Germany
Universitaetsklinikum Carl Gustav Carus, Dresden, , Germany
Local Institution - 475, Essen, , Germany
Universitaetsklinikum EssenInnere Klinik und Poliklinik, Essen, , Germany
Local Institution - 496, Freiburg, , Germany
Universitatsklinikum Freiburg, Freiburg, , Germany
Local Institution - 430, Heidelberg, , Germany
University of Heidelberg, Heidelberg, , Germany
Local Institution - 410, Tuebingen, , Germany
UKT Universitaetsklinikum Tuebingen, Tuebingen, , Germany
General Hospital of Athens Evangelismos, Athens, , Greece
Local Institution - 484, Athens, , Greece
Local Institution - 422, Athens, , Greece
University of Athens Medical school - Regional General Hospital, Athens, , Greece
Local Institution - 487, Mezourlo, , Greece
University General Hospital of Larissa, Mezourlo, , Greece
George Papanikolaou General Hospital of Thessaloniki, Thessloniki, , Greece
Local Institution - 465, Thessloniki, , Greece
Local Institution - 462, Dublin, , Ireland
Mater Misericordiae University Hospital, Dublin, , Ireland
Local Institution - 431, Dublin, , Ireland
St James Hospital, Dublin, , Ireland
Local Institution - 413, Galway, , Ireland
University College Hospital Galway, Galway, , Ireland
Rambam Health Care Campus, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Local Institution - 457, Jerusalem, , Israel
Local Institution - 433, Kfar-Saba, , Israel
Meir Medical Center, Kfar-Saba, , Israel
Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center Department of Hematology, Tel Aviv, , Israel
Local Institution - 449, Bergamo, , Italy
USC Ematologia, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Local Institution - 456, Bologna, , Italy
Policlinico S. Orsola - Malpighi, Bologna, , Italy
Local Institution - 415, Catania, , Italy
Ospedale Ferrarotto, Catania, , Italy
Local Institution - 403, Modena, , Italy
University of Modena, Modena, , Italy
IRCCS Policlinico San Matteo, Pavia, , Italy
Local Institution - 451, Pavia, , Italy
Azienda Unita Sanitaria Locale (Ausl) Pescara - Presidio Ospedaliero Di Pescara, Pescara, , Italy
Local Institution - 441, Pescara, , Italy
Azienda Ospedaliera di Reggio Emilia - Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Local Institution - 414, Reggio Emilia, , Italy
La Sapienza, University of Rome, Rome, , Italy
Local Institution - 460, Rome, , Italy
A.O.U.S. Giovanni e Ruggi d'Aragona UOC UTIC, Salerno, , Italy
Local Institution - 459, Salerno, , Italy
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
Local Institution - 453, San Giovanni Rotondo, , Italy
Azienda Ospedaliera S Maria di Terni, Terni, , Italy
Local Institution - 402, Terni, , Italy
Azienda Ospedaliera San Giovanni Battista, Torino, , Italy
Local Institution - 401, Torino, , Italy
Hitachi General Hospital, Hitachi, Ibaraki, , Japan
Local Institution - 620, Hitachi, Ibaraki, , Japan
Kameda Medical Center, Kamogawa, , Japan
Local Institution - 625, Kamogawa, , Japan
Local Institution - 626, Okayama, , Japan
Okayama Medical Center, Okayama, , Japan
Japan Red Cross Medical Center, Shibuya-ku, , Japan
Local Institution - 623, Shibuya-ku, , Japan
Local Institution - 622, Tachikawa, , Japan
National Hospital Organization Disaster Medical Center, Tachikawa, , Japan
Local Institution - 514, Groningen, , Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Local Institution - 494, Rotterdam, , Netherlands
Local Institution - 412, Oslo, , Norway
Oslo universitetssykehus, Rikshospitalet, Oslo, , Norway
St Olavs Hospital, Trondheim, , Norway
Local Institution - 411, Brzozow, , Poland
Szpital Specjalistyczny w Brzozowie, Brzozow, , Poland
Szpital Uniwersytecki nr 2 im dr. Jana Biziela, Bydgoszcz, , Poland
Local Institution - 407, Chorzow, , Poland
Zespol Szpitali Miejskich, Chorzow, , Poland
Klinika Hematologii Akademii Medycznej w Gdansku, Gdansk, , Poland
Local Institution - 463, Gdansk, , Poland
Local Institution - 440, Krakow, , Poland
Oddzial Kliniczny Kliniki Hematologii, Krakow, , Poland
Kopernik Memorial Hospital, Lodz, , Poland
Local Institution - 418, Lodz, , Poland
Klinika Hematoonkologii i Transplantacji Szpiku, Lublin, , Poland
Local Institution - 439, Lublin, , Poland
Local Institution - 437, Poznan, , Poland
Oddzial Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Poznan, , Poland
Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie, Warszawa, , Poland
Local Institution - 448, Warszawa, , Poland
Hospital de Braga, Braga, , Portugal
Local Institution - 450, Braga, , Portugal
Instituto Portugues de Oncologia de Lisboa, Francisco Gentil, Lisboa, , Portugal
Local Institution - 454, Lisboa, , Portugal
Hospital de Santa Maria, Lisboa, , Portugal
Local Institution - 466, Lisboa, , Portugal
Fundacao Champalimaud, Lisbon, , Portugal
Local Institution - 473, Lisbon, , Portugal
Local Institution - 464, Porto, , Portugal
Instituto Portugues de Oncologia do Porto, Francisco Gentil, Porto, , Portugal
Local Institution - 425, Porto, , Portugal
Hospital de Santo Antonio- Porto, Porto, , Portugal
Ad-Vance Medical Research, LLC, Ponce, , Puerto Rico
City Clinical Hospital 52, Moscow, , Russian Federation
Local Institution - 521, Moscow, , Russian Federation
Local Institution - 517, Moscow, , Russian Federation
Moscow State Healthcare Institution City clinical hospital n.a. S.P.Botkin, Moscow, , Russian Federation
Local Institution - 520, Nizhny Novgorod, , Russian Federation
State Budgetary Healthcare Institution of Nizhniy Novgorod Region, Nizhny Novgorod, , Russian Federation
Russian Research Institute of Hematology and Transfusiology of the Federal Biomedical Agency, Saint Petersburg, , Russian Federation
Hospital Universitari Germans Trias i Pujol Can Ruti, Badalona (Barcelona), , Spain
Local Institution - 423, Badalona (Barcelona), , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Local Institution - 424, Barcelona, , Spain
Hospital de Basurto-Osakidetza, Bilbao, , Spain
Hospital 12 de Octubre, Madrid, , Spain
Local Institution - 452, Madrid, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Local Institution - 502, Murcia, , Spain
Complejo Hospitalario De Orense, Orense, , Spain
Local Institution - 526, Orense, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Local Institution - 434, Pamplona, , Spain
Complejo Hospitalario Nuestra Senora de Valme, Sevilla, , Spain
Local Institution - 492, Sevilla, , Spain
Hospital Universitario y Politecnico La Fe, Valencia, , Spain
Falu lasarett, Falun, , Sweden
Local Institution - 426, Falun, , Sweden
Local Institution - 478, Gothenburg, , Sweden
Sahlgrenska University Hospital, Gothenburg, , Sweden
Local Institution - 429, Luleå, , Sweden
Sunderby Sjukhus, Luleå, , Sweden
Karolinska University, Stockholm, , Sweden
Local Institution - 471, Stockholm, , Sweden
Sundsvalls sjukhus- Medicinkliniken, Sundsvall, , Sweden
Ankara University Medical Faculty Cebeci Hospital, Ankara, , Turkey
Local Institution - 428, Ankara, , Turkey
Gazi Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Local Institution - 409, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi, Ankara, , Turkey
Local Institution - 408, Ankara, , Turkey
Local Institution - 488, Antalya, , Turkey
Medstar Antalya Hospital, Antalya, , Turkey
Eskisehir Osmangazi University, Eskisehir, , Turkey
Local Institution - 420, Eskisehir, , Turkey
Local Institution - 421, Gaziantep, , Turkey
Gaziantep University, Gaziantep, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi, Istanbul, , Turkey
Local Institution - 445, Istanbul, , Turkey
Istanbul University Faculty of Medicine, Istanbul, , Turkey
Local Institution - 474, Istanbul, , Turkey
Ege University Medical School, Izmir, , Turkey
Local Institution - 419, Izmir, , Turkey
Karadeniz Teknik Universitesi Tip Fakultesi Farabi Hastanesi, Trabzon, , Turkey
Local Institution - 404, Trabzon, , Turkey
The Royal Bournemouth Hospital, Bournemouth, , United Kingdom
Kent and Canterbury Hospital, Canterbury Kent, , United Kingdom
Local Institution - 479, Canterbury Kent, , United Kingdom
Local Institution - 406, Edinburgh Scotland, , United Kingdom
Western General Hospital, Edinburgh Scotland, , United Kingdom
Local Institution - 490, London, , United Kingdom
University College London Hospitals, London, , United Kingdom
Kings College Hospital, London, , United Kingdom
Local Institution - 461, London, , United Kingdom
Local Institution - 512, Oxford, , United Kingdom
University of Oxford, Oxford, , United Kingdom
Derriford Hospital Plymouth Oncology Centre Clinical Trials Unit, Plymouth, , United Kingdom
Local Institution - 515, Plymouth, , United Kingdom
Local Institution - 500, Sheffield, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust - Royal Hallamshire Hospital, Sheffield, , United Kingdom
Local Institution - 493, Southampton, , United Kingdom
Southampton General Hospital, Southampton, , United Kingdom
University Hospital of North Staffordshire Nhs Trust - City General Hospital, Stoke-On-Trent, , United Kingdom
Local Institution - 405, Swansea, , United Kingdom
Singleton Hospital, Swansea, , United Kingdom
Local Institution - 482, Wolverhampton, , United Kingdom
New Cross Hospital, Wolverhampton, , United Kingdom
Local Institution - 436, Worcester, , United Kingdom
Worcestershire Acute Hospitals NHS Trust, Worcester, , United Kingdom
Contact Details
Name: Bristol Myers-Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Name: Amine Bensmaine, MD
Affiliation: Celgene Corporation
Role: STUDY_DIRECTOR
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