A Study of PS-341 Given to Patients With Multiple Myeloma Who Experienced Progressive Disease After Receiving Dexamethasone in M34101-039
- Conditions
- Multiple Myeloma
- Registration Number
- NCT00063726
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (76)
Emory University
🇺🇸Atlanta, Georgia, United States
Texas Oncology at Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Western Pennsylvania Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Toronto General Research Institute
🇨🇦Toronto, Ontario, Canada
Hadassah University Hospital
🇮🇱Jerusalem, Israel
Hospital Clinico Universitario de Barcelona, Hematologia
🇪🇸Barcelona, Spain
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie
🇧🇪Charleroi, Belgium
Hoptial Hotel Dieu
🇫🇷Paris, Cedex, France
Hopital Antoine Beclere
🇫🇷Clamart, France
University of Erlangen-Nurenberg, Division of Hematology/Oncology
🇩🇪Erlangen, Germany
Huddinge University Hospital M54, Department of Haematology
🇸🇪Stockholm, Sweden
Leeds General Infirmary, Department of Haematology
🇬🇧Leeds, United Kingdom
Universitatsklinikum Charite Medizinische Klinik und Poliklinik
🇩🇪Berlin, Germany
McGill University Clinical Research Program
🇨🇦Montreal, Quebec, Canada
Hospital Claude Huriez
🇫🇷Lile, Cedex, France
Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique
🇫🇷Toulouse, Cedex, France
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
University Hospital of Salamanca, Hematology Dept
🇪🇸Salamanca, Spain
Department of Haematology, ICSM
🇬🇧London, United Kingdom
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of Arkansas Medical Sciences
🇺🇸Little Rock, Arkansas, United States
City of Hope
🇺🇸Duarte, California, United States
Kaiser Permanente Medical Center
🇺🇸Vallejo, California, United States
Med Star Institute
🇺🇸Washington, District of Columbia, United States
Hematology/Oncology Associates, PA
🇺🇸Jacksonville, Florida, United States
Northwestern University Medical School
🇺🇸Chicago,, Illinois, United States
Alta Bates Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Scripps Clinic, Green Cancer Center
🇺🇸La Jolla, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Loyola University Medical Center: Cardinal Bernardin Cancer Center
🇺🇸Maywood, Illinois, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, 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
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
Charlotte Hematology Oncology Associates
🇺🇸Charlotte, North Carolina, United States
LSU HC
🇺🇸Sheveport, Louisiana, United States
University of Pennsylvania Cancer Center
🇺🇸Philadelphia,, Pennsylvania, United States
Tufts England Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Center
🇺🇸Boston, Massachusetts, United States
Mass General Hospital
🇺🇸Boston, Massachusetts, United States
Hackensack University Medical Center, David Jurist Research Building
🇺🇸Hackensack, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Fred Hutchinson Cancer Center
🇺🇸Seattle, Washington, 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
Adult Leukaemia Unit, Christie Hospital
🇬🇧Withington, Manchester, United Kingdom
VA Medical Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Miami
🇺🇸Miami, Florida, United States
Division of Hematology/Stem Cell Transplant
🇺🇸Nashville, Tennessee, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hospital Saint-Louis
🇫🇷Paris, France
Centre Hospitalier Lyon Sud
🇫🇷Cedex, France
Universitatsklinikum Heidelberg
🇩🇪Heidelberg, Germany
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Univ. of Michigan Comp. Cancer Center,
🇺🇸Ann Arbor, Michigan, United States
Lombardi Cancer Center, Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet
🇩🇪Bonn, Germany
Uniklinikum Muenster, Medizinische Klinik und Poliklinik A
🇩🇪Muenster, Germany
Belfast City Hospital, Haematology Department
🇮🇪Belfast, Ireland
Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1
🇮🇹Roma, Italy
Azienda Ospedaliera, S. Giovanni Battista
🇮🇹Torino, Italy
Medical University Clinic (Oncology/Haematology)
🇩🇪Hamburg, Germany
Hopital de Brabois
🇫🇷Vandoeuvre, Cedex, France
Johannes-Gutenberg-University Medical School, Department of Medicine III
🇩🇪Mainz, Germany
Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology
🇳🇱Rotterdam, Netherlands
Trident Palmetto Hematology/Oncology
🇺🇸Charleston, South Carolina, United States