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Brief Title: PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Official Title: An International, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study ID: NCT00048230
Brief Summary: This study will compare the efficacy of PS-341 versus high dose dexamethasone.
Detailed Description:
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
City of Hope, Duarte, California, United States
Scripps Clinic, La Jolla, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Kaiser Permanente Oncology Clinical Trials, Vallejo, California, United States
Lombardi Cancer Center, Georgetown University Medical Center, Washington, District of Columbia, United States
Med Star Institute, Washington Cancer Center, Washington, District of Columbia, United States
Hematology/Oncology Associates, PA, Jacksonville, Florida, United States
University of Miami, Miami, Florida, United States
H. Lee Moffitt Cancer Center, University of S. Florida, Tampa, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern University Medical School, Chicago, Illinois, United States
Loyola University Medical Center: Cardinal Bernardin Cancer Center, Maywood,, Illinois, United States
LSU HC, Shreveport, Louisiana, United States
Tufts New England Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Kirstein Room 135, Boston, Massachusetts, United States
Department of Internal Medicine, Univ. of Michigan Comp. Cancer Center, Ann Arbor, Michigan, United States
VA Medical Center, Sections of Hematology/Oncology, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine, St. Louis, Missouri, United States
Hackensack University Medical Center, David Jurist Research Building, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Long Island Jewish Medical Center, Division of Hematology/Oncology, New Hyde Park, New York, United States
St. Vincent's Comprehensive Cancer Center, Research Department, New York, New York, United States
NY Presbyterian Hospital, New York, New York, United States
Rochester General Hospital, Lipson Cancer Blood Center, Rochester, New York, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, New York, United States
Carolinas Hematology-Oncology Associates, Charlotte, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Dept. of Human Oncology, Pittsburgh, Pennsylvania, United States
Trident Palmetto Hematology/Oncology, Charleston, South Carolina, United States
Division of Hematology/Stem Cell Transplant, Nashville, Tennessee, United States
Texas Oncology at Medical City Dallas Hospital, Dallas, Texas, United States
Baylor Institute for Immunology Research, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie, Wien, , Austria
ACZA, Campus Stuivenberg, Antwerpen, , Belgium
CHU Erasme / ULB University, Hematology 7th Floor, Brussels, , Belgium
Institut Jules Bordet, Unite Sterile, Bruxelles, , Belgium
C.H. Notre Dame-Reine Fabiola, Charleroi, , Belgium
UZ Gasthuisberg, Department of Hematology, Leuven, , Belgium
AZ St. Jan, Dept. of Haematology, Rugge, , Belgium
Cliniques Universitaires U.C.L de Mont Godinne, Hopital de Jour, Yvoir, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
London Health Sciences Center, London, Ontario, Canada
Toronto General Research Institute, Princess Margaret Hospital, Toronto, Ontario, Canada
Royal Victoria Hospital, Montreal, Quebec, Canada
Hospital Claude Huriez, Service des Maladies du Sang, Lile, Cedex, France
Nantes Hotel Dieu Hospital, Nantes, Cedex, France
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique, Toulouse, Cedex, France
Institut Gustave-Roussy, Service d'Hematologie, Villejuif, Cedex, France
Hopital Antoine Beclere, Hopital de Jour de Medecine Interne, Clamart, , France
Hopital Hotel Dieu, Service d'hematologie et oncologie medicale, Paris, , France
Hopital Saint-Louis, Direction Financiere, Paris, , France
Hopital Cochin, Service de Hematologie, Paris, , France
Centre Hospitalier Lyon Sud, Pierre Benite Cedex, , France
Hopital de Brabois, Service Hematologie et Medecine Interne, Vandoeuvre, , France
Universitatsklinikum Charite, Abt. Fuer Haematologie/Onkologie, Berlin, , Germany
Medizinische Klinik und Poliklinik 1, Bonn, , Germany
Universitatsklinikum Carl Gustav Carus, Dresden, , Germany
University of Erlangen-Nurenberg, Division of Hematology/Oncology, Erlangen, , Germany
Freiburg University Medical Center, Dept. of Hemayology/Oncology, Freiburg, , Germany
Medical University Clinic (Oncology/Haematology), Hamburg, , Germany
St. Marien Hospital, Klinik fur Hamatologie und Onkologie, Hamm, , Germany
Universitatsklinikum Heidelberg, Abt. Fur Haematologie und Onkologie, Heidelberg, , Germany
University of Essen Medical School, Dept. of Internal Medicine, Hufelandstr, , Germany
Johannes Gutenberg-Universitat Mainz, III. Med Klinik und Poliknik, Mainz, , Germany
Uniklinikum Muenster, Muenster, , Germany
Eberhard-Karls Universitat, Medizinische Klinik, Tubingen, , Germany
Belfast City Hospital, Belfast, , Ireland
RAMBAM Medical Center, Department of Hematology and Bone, Haifa, , Israel
Hadassah University Hospital, Jerusalem, , Israel
Dipartmento Clinico esperimentale Di Oncologia et Ematolgia, Bergamo, , Italy
Instituto di Ematologia e Oncologia Medica, Lorenzo e Ariosto Seragnoli, Bologna, , Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia, Roma, , Italy
Azienda Ospedaliera, S. Giovanni Battista, Torino, , Italy
Dept. of Clinical Hematology, Academic Medical Center, Amsterdam, , Netherlands
Department of Hematology, Erasmus MC, 1a, Daniel Den Hoed, Rotterdam, , Netherlands
Dept. Hematology, University Medical Centre, Utrecht, , Netherlands
Hospital Clinico Universitario de Barcelona, Haematology Department, Barcelona, , Spain
University Hospital of Salamanca, Salamanca, , Spain
Department of Haematology, Huddinge University Hospital M54, Stockholm, , Sweden
Karolinska Hospital, Dept. of Hematology, Stockholm, , Sweden
Adult Leukaemia Unit, Christie Hospital, Withington, Manchester, United Kingdom
Department of Haematology, Queen Elizabeth Hospital, Birmingham, , United Kingdom
Leeds General Infirmary, Leeds, , United Kingdom
Department of Haematology, St. Bartholomew's Hospital, London, , United Kingdom
Department of Haematology, ICSM, Hammersmith Hospital, London, , United Kingdom
Royal Marsden Hospital, Leukaemia and Myeloma Units, Sutton, , United Kingdom