Conditions: Multiple Myeloma
Keywords: Treatment for patients with multiple myeloma who have received no prior treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
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 complete response (CR)/ very good partial response (VGPR) rate.

Detailed description:

Arms:
arm 1: VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) arm 2: VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) arm 3: VELCADE (bortezomib), dexamethasone, cyclophosphamide arm 4: Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide

Interventions: intervention 1: VELCADE (bortezomib) intervention 2: dexamethasone intervention 3: cyclophosphamide intervention 4: Revlimid (lenalidomide)
Intervention descriptions: intervention 1: bortezomib 1.3 mg/m\^2 given via 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). intervention 2: dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop intervention 3: cyclophosphamide 500 mg/m\^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop intervention 4: lenalidomide 25 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDR arm)

lenalidomide 15 mg orally on days 1 to 14 of a 3-week cycle for 8 cycles then stop (VDCR arm)

Protocol document: