Phase I/II Study of Lenalidomide (Revlimid), Thalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
The goal of the Phase I portion of this clinical research study is to find the highest tolerated dose of the combination of thalidomide, lenalidomide, and dexamethasone that can be given to patients with relapsed or refractory MM. The goal of the Phase II portion of this study is to learn if the drug combination can help to control the disease. The safety of the drug combination will be studied in both phases.
Treatment Location: N/A
Phase 1: Primary Objectives 1. To determine the maximum tolerated dose (MTD) of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM). Secondary Objectives 1. To determine the Overall response rate (ORR) 2. To determine the Time to progression (TTP) 3. To determine the Progression free survival (PFS) 4. To determine the Time to best response Phase 2: Primary objective: 1. To determine the overall (complete remission (CR) + very good partial response (VGPR)+ partial response (PR)) response rate of the combination after 4 cycles of therapy. Secondary Objectives 1. To determine the CR, VGPR 2. To determine the Time to progression (TTP) 3. To determine the Progression free survival (PFS) 4. To determine the Time to best response 5. To assess the safety of the combination of LTD in patients with RRMM. 6. Time to next therapy 7. Symptom measurement - Multiple-symptom assessment tool
IRB Review and Approval Date: 05/14/2009
Recruitment Status: Closed
Projected Accrual: N/A