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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Relapsed Multiple Myeloma Refractory Multiple Myeloma |
Anti-Inflammatory Agents Dexamethasone Immunoproliferative Disorders Antineoplastic Agents, Hormonal Blood Protein Disorders Hematologic Diseases Hormone Antagonists Blood Coagulation Disorders Bortezomib Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Antiemetics |
Paraproteinemias Hemostatic Disorders Hormones Glucocorticoids Protease Inhibitors Multiple Myeloma Hemorrhagic Disorders Peripheral Nervous System Agents Lymphoproliferative Disorders Dexamethasone acetate Neoplasms, Plasma Cell |
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 |