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Brief Title: A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
Official Title: An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in Millennium Protocol M34101-039
Study ID: NCT00063726
Brief Summary: The purpose of this study is to allow patients to receive VELCADE™ (bortezomib) for Injection who experienced progressive disease(PD) while receiving high-dose dexamethasone from the M34101-039 study.
Detailed Description: The rationale for Amendment 2 is 2-fold. First, it is intended that this study serve as a rollover protocol for patients who experience progressive disease (PD) after receiving the comparator treatment, high-dose dexamethasone, in MPI Study M34101-039, thereby ultimately providing all patients who participate in Study M34101-039 and require treatment for their disease access to VELCADE™ (bortezomib) for Injection, formerly known as MLN341, LDP-341 and PS-341.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arkansas Medical Sciences, Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
City of Hope, Duarte, California, United States
Scripps Clinic, Green Cancer Center, La Jolla, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Kaiser Permanente Medical Center, Vallejo, California, United States
Lombardi Cancer Center, Georgetown University Medical Center, Washington, District of Columbia, United States
Med Star Institute, 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, 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, Sheveport, Louisiana, United States
Tufts England Medical Center, Boston, Massachusetts, United States
Mass General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Center, Boston, Massachusetts, United States
Univ. of Michigan Comp. Cancer Center,, Ann Arbor, Michigan, United States
VA Medical Center, 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, New Hyde Park, New York, United States
St. Vincent's Comprehensive Cancer Center, New York, New York, United States
Weill Medical College of Cornell University, NY Presbyterian Hospital, New York, New York, United States
Rochester General Hospital, Rochester, New York, United States
University of Rochester Medical Center, James P. Wilmot Cancer Center, Rochester, New York, United States
Charlotte 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, 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
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
AZ St. Jan, Dept of Haematology, Brugge, , Belgium
CHU Erasme / ULB University, Brussels, , Belgium
Institue Jules Bordet, Unite Sterile, Bruxelles, , Belgium
C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie, Charleroi, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
London Health Sciences Center, London, Ontario, Canada
Toronto General Research Institute, Toronto, Ontario, Canada
McGill University Clinical Research Program, Montreal, Quebec, Canada
Hospital Claude Huriez, Lile, Cedex, France
Hoptial Hotel Dieu, Paris, Cedex, France
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique, Toulouse, Cedex, France
Hopital de Brabois, Vandoeuvre, Cedex, France
Centre Hospitalier Lyon Sud, Cedex, , France
Hopital Antoine Beclere, Clamart, , France
Hospital Saint-Louis, Paris, , France
Universitatsklinikum Charite Medizinische Klinik und Poliklinik, Berlin, , Germany
Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet, Bonn, , Germany
University of Erlangen-Nurenberg, Division of Hematology/Oncology, Erlangen, , Germany
Medical University Clinic (Oncology/Haematology), Hamburg, , Germany
Universitatsklinikum Heidelberg, Heidelberg, , Germany
Johannes-Gutenberg-University Medical School, Department of Medicine III, Mainz, , Germany
Uniklinikum Muenster, Medizinische Klinik und Poliklinik A, Muenster, , Germany
Belfast City Hospital, Haematology Department, Belfast, , Ireland
Hadassah University Hospital, Jerusalem, , Israel
Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1, Roma, , Italy
Azienda Ospedaliera, S. Giovanni Battista, Torino, , Italy
Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology, Rotterdam, , Netherlands
Hospital Clinico Universitario de Barcelona, Hematologia, Barcelona, , Spain
University Hospital of Salamanca, Hematology Dept, Salamanca, , Spain
Huddinge University Hospital M54, Department of Haematology, Stockholm, , Sweden
Adult Leukaemia Unit, Christie Hospital, Withington, Manchester, United Kingdom
Queen Elizabeth Hospital, Birmingham, , United Kingdom
Leeds General Infirmary, Department of Haematology, Leeds, , United Kingdom
Department of Haematology, ICSM, London, , United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom