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Sponsored by: |
Millennium Pharmaceuticals, Inc. |
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Information provided by: | Millennium Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00507416 |
This is a randomized, open label, multicenter clinical trial to compare the efficacy and safety of VELCADE dexamethasone versus VELCADE, thalidomide, and dexamethasone versus VELCADE, melphalan, and prednisone in patients with previously untreated multiple myeloma who are not considered candidates for high-dose chemotherapy and autologous stem cell transplantation. This study will consist of a Screening period (generally 4 weeks or less), an Induction Treatment period (approximately 6 months), a Maintenance Treatment period (approximately 6 months), and a Post-treatment period.
Condition | Intervention | Phase |
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Multiple Myeloma |
Drug: bortezomib, thalidomide, and dexamethasone (VTD) Drug: bortezomib and dexamethasone (VD) Drug: bortezomib, melphalan and prednisone (VMP) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Randomized Phase 3b Study of Three Treatment Regimens in Subjects With Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE,Thalidomide, and Dexamethasone Versus VELCADE and Dexamethasone Versus VELCADE, Melphalan, and Prednisone |
Estimated Enrollment: | 500 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Bortezomib, Thalidomide, and Dexamethasone (VTD)
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Drug: bortezomib, thalidomide, and dexamethasone (VTD)
VELCADE® (bortezomib): 1.3 mg/m2/dose administered as a 3- to 5-second IV bolus injection on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Thalidomide: 100 mg PO QD on Days 1-21 of a 21-day cycle during Cycles 1-8. Dexamethasone: 20 mg orally (PO) once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after VELCADE® administration), and then 20 mg PO QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8 Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive VELCADE® at 1.6 mg/m2/dose IV (as above) on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. |
2: Experimental
Bortezomib and Dexamethasone (VD)
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Drug: bortezomib and dexamethasone (VD)
VELCADE® (bortezomib): 1.3 mg/m2/dose administered as a 3- to 5-second IVbolus injection on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Dexamethasone: 20 mg orally (PO) once daily (QD) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle during Cycles 1-4 (ie, on the day of and day after VELCADE® administration), and then 20 mg PO QD on Days 1, 2, 4, and 5 of a 21-day cycle during Cycles 5-8. Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive VELCADE® at 1.6 mg/m2/dose IV (as above) on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. |
3: Experimental
Bortezomib, melphalan, and prednisone (VMP)
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Drug: bortezomib, melphalan and prednisone (VMP)
VELCADE® (bortezomib): 1.3 mg/m2/dose administered as a 3- to 5-second IVbolus injection on Days 1, 4, 8, and 11 of each 21-day cycle during Cycles 1-8. Melphalan: 9 mg/m2 PO QD on Days 1-4 every other cycle during Cycles 1-8. Prednisone: 60 mg/m2 PO QD on Days 1-4 every other cycle during Cycles 1-8. Dosing Schedule for the Maintenance Treatment Periods (Cycles 9 though 13) All subjects will receive VELCADE® at 1.6 mg/m2/does IV (as above) on Days 1, 8, 15, and 22 of a 35-day cycle during Cycles 9-13. |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christine Colby, Pharm.D. | 1-866-835-2233 | medical@mlnm.com |
Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
Study ID Numbers: | C05009 |
Study First Received: | July 25, 2007 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00507416 |
Health Authority: | United States: Institutional Review Board |
Dexamethasone Melphalan Prednisone Immunoproliferative Disorders Thalidomide 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 Anti-Infective Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Anti-Bacterial Agents Therapeutic Uses Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents |
Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents, Hormonal Growth Substances Gastrointestinal Agents Enzyme Inhibitors Angiogenesis Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Protease Inhibitors Neoplasms Autonomic Agents Myeloablative Agonists Peripheral Nervous System Agents |