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| Sponsors and Collaborators: |
Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00507442 |
Purpose
The purpose of this Phase 1/2 study is to evaluate the efficacy and safety of treatment with VELCADE, dexamethasone, and Revlimid® (VDR) as well as VELCADE, dexamethasone, cyclophosphamide, and Revlimid (VDCR) in patients with multiple myeloma who have received no prior treatment. This study will evaluate whether the addition of Revlimid to VELCADE and Dexamethasone will increase the CR/ very good partial response (VGPR) rate.
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Myeloma |
Drug: bortezomib + dexamethasone + lenalidomide Drug: bortezomib + dexamethasone + cyclophosphamide + lenalidomide Drug: bortezomib + dexamethasone + cyclophosphamide |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 1/2 Study of VELCADE®, Dexamethasone, and Revlimid® Versus VELCADE, Dexamethasone, Cyclophosphamide, and Revlimid Versus VELCADE, Dexamethasone and Cylophosphamide in Subjects With Previously Untreated Multiple Myeloma |
| Estimated Enrollment: | 156 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
VDR: Experimental
bortezomib, dexamethasone, and lenalidomide
|
Drug: bortezomib + dexamethasone + lenalidomide
bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. lenalidomide: 25 mg PO on days 1 to 14 of a 3-week cycle for 8 cycles then stop. bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. cyclophosphamide: MTD from the phase I part PO on days 1 and 8 of a 3-week cycle for 8 cycles, then stop. lenalidomide: 15 mg PO on days 1 to 14 of a 3-week cycle for 8 cycles then stop. Dose may be 20 mg or 25 mg if escalation of lenalidomide is performed in Phase 1, following dose escalation of cyclophosphamide to 500 mg/m2 bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. cyclophosphamide: 400 mg/m2, or MTD from the Phase 1 part if the MTD is higher, PO on days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
|
VDCR: Experimental
VELCADE, DEXAMETHASONE, CYCLOPHOSPHAMIDE, REVLIMID
|
Drug: bortezomib + dexamethasone + lenalidomide
bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. lenalidomide: 25 mg PO on days 1 to 14 of a 3-week cycle for 8 cycles then stop. bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. cyclophosphamide: MTD from the phase I part PO on days 1 and 8 of a 3-week cycle for 8 cycles, then stop. lenalidomide: 15 mg PO on days 1 to 14 of a 3-week cycle for 8 cycles then stop. Dose may be 20 mg or 25 mg if escalation of lenalidomide is performed in Phase 1, following dose escalation of cyclophosphamide to 500 mg/m2 bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. cyclophosphamide: 400 mg/m2, or MTD from the Phase 1 part if the MTD is higher, PO on days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
|
VDC: Experimental
VELCADE, DEXAMETHASONE, CYCLOPHOSPHAMIDE
|
Drug: bortezomib + dexamethasone + lenalidomide
bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. lenalidomide: 25 mg PO on days 1 to 14 of a 3-week cycle for 8 cycles then stop. bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. cyclophosphamide: MTD from the phase I part PO on days 1 and 8 of a 3-week cycle for 8 cycles, then stop. lenalidomide: 15 mg PO on days 1 to 14 of a 3-week cycle for 8 cycles then stop. Dose may be 20 mg or 25 mg if escalation of lenalidomide is performed in Phase 1, following dose escalation of cyclophosphamide to 500 mg/m2 bortezomib: 1.3mg/m2/dose IV on days 1,4,8,and 11 of a 3-week cycle for 8 cycles, then on days 1,8,15 and 22 of a 6-week cycle for 4 cycles (maintenance). dexamethasone: 40 mg oral on day 1,8, and 15 of a 3-week cycle for 8 cycles, then stop. cyclophosphamide: 400 mg/m2, or MTD from the Phase 1 part if the MTD is higher, PO on days 1 and 8 of a 3-week cycle for 8 cycles, then stop. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Multiple myeloma diagnosed according to the following standard criteria:
Major criteria
Minor criteria
Any of the following sets of criteria will confirm the diagnosis of multiple myeloma
Subjects must have measurable disease requiring systemic therapy. Measurable disease is defined by at least 1 of the following 3 measurements:
Exclusion Criteria:
Contacts and Locations| Contact: Christine Colby, Pharm.D. | 1-866-835-2233 | medical@mlnm.com |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55904-0001 | |
More Information
| Responsible Party: | Millennium Pharmaceuticals, Inc. ( Clinical Study Medical Monitor ) |
| Study ID Numbers: | C05008 |
| Study First Received: | July 25, 2007 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00507442 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Treatment for patients with multiple myeloma who have received no prior treatment |
|
Anti-Inflammatory Agents Dexamethasone Immunologic Factors Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Hemorrhagic Disorders Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders |
Antineoplastic Agents, Hormonal Hematologic Diseases Blood Coagulation Disorders Bortezomib Vascular Diseases Lenalidomide Immunosuppressive Agents Glucocorticoids Protease Inhibitors Multiple Myeloma Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Lymphoproliferative Disorders Antirheumatic Agents Neoplasms, Plasma Cell |
|
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Cyclophosphamide Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses |
Cardiovascular Diseases Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Bortezomib Gastrointestinal Agents Vascular Diseases Lenalidomide Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents |