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| Sponsor: | Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00063726 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 600 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Arkansas | |
| University of Arkansas Medical Sciences | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Alta Bates Comprehensive Cancer Center | |
| Berkeley, California, United States, 94704 | |
| City of Hope | |
| Duarte, California, United States, 91010 | |
| Loma Linda University Medical Center | |
| Loma Linda, California, United States, 92354 | |
| Kaiser Permanente Medical Center | |
| Vallejo, California, United States, 94589 | |
| Scripps Clinic, Green Cancer Center | |
| La Jolla, California, United States, 92307 | |
| United States, District of Columbia | |
| Lombardi Cancer Center, Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Med Star Institute | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 33612 | |
| Hematology/Oncology Associates, PA | |
| Jacksonville, Florida, United States, 32207 | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| Loyola University Medical Center: Cardinal Bernardin Cancer Center | |
| Maywood, Illinois, United States, 60153 | |
| Northwestern University Medical School | |
| Chicago,, Illinois, United States, 60611 | |
| United States, Louisiana | |
| LSU HC | |
| Sheveport, Louisiana, United States, 71130 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Center | |
| Boston, Massachusetts, United States, 02115 | |
| Mass General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Tufts England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Michigan | |
| Univ. of Michigan Comp. Cancer Center, | |
| Ann Arbor, Michigan, United States, 48109-0922 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| VA Medical Center | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Hackensack University Medical Center, David Jurist Research Building | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| University of Rochester Medical Center, James P. Wilmot Cancer Center | |
| Rochester, New York, United States, 14642 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
| St. Vincent's Comprehensive Cancer Center | |
| New York, New York, United States, 10011 | |
| Weill Medical College of Cornell University, NY Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
| Rochester General Hospital | |
| Rochester, New York, United States, 14621 | |
| United States, North Carolina | |
| Charlotte Hematology Oncology Associates | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| University of Pennsylvania Cancer Center | |
| Philadelphia,, Pennsylvania, United States, 19104 | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Carolina | |
| Trident Palmetto Hematology/Oncology | |
| Charleston, South Carolina, United States, 29406 | |
| United States, Tennessee | |
| Division of Hematology/Stem Cell Transplant | |
| Nashville, Tennessee, United States, 37232-5505 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Texas Oncology at Medical City Dallas Hospital | |
| Dallas, Texas, United States, 75225 | |
| United States, Washington | |
| Fred Hutchinson Cancer Center | |
| Seattle, Washington, United States, 98109 | |
| United States, Wisconsin | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Austria | |
| Wilhelminenspital Wien, Abt. Fur Med. und Medizinische Onkologie | |
| Wien, Austria, 1171 | |
| Belgium | |
| CHU Erasme / ULB University | |
| Brussels, Belgium, 1070 | |
| AZ St. Jan, Dept of Haematology | |
| Brugge, Belgium, 8000 | |
| ACZA, Campus Stuivenberg | |
| Antwerpen, Belgium, 2060 | |
| C.H. Notre Dame-Reine Fabiola, Department d'Oncologie et Hematolgie | |
| Charleroi, Belgium, 6000 | |
| Institue Jules Bordet, Unite Sterile | |
| Bruxelles, Belgium, 1000 | |
| Canada, Alberta | |
| Cross Cancer Institute | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Canada, Ontario | |
| London Health Sciences Center | |
| London, Ontario, Canada, N6A 4G5 | |
| Toronto General Research Institute | |
| Toronto, Ontario, Canada, M5G2M9 | |
| Canada, Quebec | |
| McGill University Clinical Research Program | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| France | |
| Centre Hospitalier Lyon Sud | |
| Cedex, France, 69495 | |
| Hopital Antoine Beclere | |
| Clamart, France, 92140 | |
| Hospital Saint-Louis | |
| Paris, France, 75010 | |
| France, Cedex | |
| Hopital Purpan, Pavillon Dieulafoy, Service d'Hematologie Clinique | |
| Toulouse, Cedex, France, 31059 | |
| Hopital de Brabois | |
| Vandoeuvre, Cedex, France, 54511 | |
| Hospital Claude Huriez | |
| Lile, Cedex, France, 59037 | |
| Hoptial Hotel Dieu | |
| Paris, Cedex, France, 75181 | |
| Germany | |
| Johannes-Gutenberg-University Medical School, Department of Medicine III | |
| Mainz, Germany, 55101 | |
| Universitatsklinikum Charite Medizinische Klinik und Poliklinik | |
| Berlin, Germany, 10098 | |
| Universitatsklinikum Heidelberg | |
| Heidelberg, Germany, 69115 | |
| University of Erlangen-Nurenberg, Division of Hematology/Oncology | |
| Erlangen, Germany, 91054 | |
| Medical University Clinic (Oncology/Haematology) | |
| Hamburg, Germany, 20246 | |
| Medizinsche Klinik und Poliklinik 1, Rheinische Friedrich-Wilhelms-Universitaet | |
| Bonn, Germany, 53127 | |
| Uniklinikum Muenster, Medizinische Klinik und Poliklinik A | |
| Muenster, Germany, 48129 | |
| Ireland | |
| Belfast City Hospital, Haematology Department | |
| Belfast, Ireland, BT9 7AB | |
| Israel | |
| Hadassah University Hospital | |
| Jerusalem, Israel, 91120 | |
| Italy | |
| Azienda Ospedaliera, S. Giovanni Battista | |
| Torino, Italy, 10126 | |
| Dipartimento di Biotecnologie Cellulari ed Ematologia, Az. Policlinico Umberto 1 | |
| Roma, Italy, 00161 | |
| Netherlands | |
| Erasmus MC, 1a, Daniel Den Hoed, Department of Hematology | |
| Rotterdam, Netherlands, 3075 | |
| Spain | |
| Hospital Clinico Universitario de Barcelona, Hematologia | |
| Barcelona, Spain, 08036 | |
| University Hospital of Salamanca, Hematology Dept | |
| Salamanca, Spain, 37007 | |
| Sweden | |
| Huddinge University Hospital M54, Department of Haematology | |
| Stockholm, Sweden, 14186 | |
| United Kingdom | |
| Department of Haematology, ICSM | |
| London, United Kingdom, W12 0NN | |
| Leeds General Infirmary, Department of Haematology | |
| Leeds, United Kingdom, LS1 3EX | |
| Queen Elizabeth Hospital | |
| Birmingham, United Kingdom, B15 2TH | |
| Royal Marsden Hospital | |
| Sutton, United Kingdom, SM2 5PT | |
| United Kingdom, Manchester | |
| Adult Leukaemia Unit, Christie Hospital | |
| Withington, Manchester, United Kingdom, M20 4BX | |
More Information
| Study ID Numbers: | M34101-040 |
| Study First Received: | July 2, 2003 |
| Last Updated: | July 12, 2007 |
| ClinicalTrials.gov Identifier: | NCT00063726 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Relapsed Multiple Myeloma Refractory Multiple Myeloma |
|
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Immunoproliferative Disorders |
Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Vascular Diseases Gastrointestinal Agents Enzyme Inhibitors Glucocorticoids Pharmacologic Actions Protease Inhibitors Multiple Myeloma Neoplasms Autonomic Agents Peripheral Nervous System Agents |