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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00048230 |
This study will compare the efficacy of PS-341 versus high dose dexamethasone.
Condition | Intervention | Phase |
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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, Multi-Center, Randomized, Open-Label Study of PS-341 (VELCADE™) Versus High-Dose Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Study ID Numbers: | M34101-039 |
Study First Received: | October 28, 2002 |
Last Updated: | July 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00048230 |
Health Authority: | United States: Food and Drug Administration |
Relapsed Multiple Myeloma Refractory Multiple Myeloma |
Dexamethasone Immunoproliferative Disorders Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Paraproteinemias |
Hemostatic Disorders Multiple Myeloma Hemorrhagic Disorders Multiple myeloma Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Enzyme Inhibitors |
Hormones Glucocorticoids Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Therapeutic Uses Cardiovascular Diseases Peripheral Nervous System Agents Central Nervous System Agents |