Conditions: Multiple Myeloma
Keywords: newly diagnosed multiple myeloma Lenalidomide Revlimid phase III
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1623
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the safety and efficacy of Lenalidomide plus low dose dexamethasone to that of the combination of melphalan, prednisone and thalidomide.

Detailed description:
CC-5013-MM020/IFM 07-01 is a Phase III, multicenter, randomized, open-label, 3-arm study that will compare the efficacy and safety of two Lenalidomide plus low-dose dexamethasone regimens given for two different durations of time (i.e., until progressive disease \[PD\] or for up to a maximum of 18 four-week cycles) to that of MPT given for a maximum of 12 six-week cycles.

Arms:
arm 1: Lenalidomide plus low-dose dexamethasone given until disease progression arm 2: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles arm 3: Combination of Melphalan, Prednisone and Thalidomide given for 12 six-week cycles

Interventions: intervention 1: Lenalidomide and low-dose dexamethasone intervention 2: Lenalidomide plus low-dose dexamethasone given for 18 four-week cycles intervention 3: Melphalan, Prednisone and Thalidomide
Intervention descriptions: intervention 1: Lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg 20mg, or 25 mg capsules, given either days 1-21 of each 28 day cycles or given every other day for 21 days until documentation of PD.

Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle up to disease progression intervention 2: lenalidomide - oral, 2.5mg, 5mg, 10mg, 15mg, 20 mg or 25 mg capsules given on days 1-21 of each 28 day cycle or every other day for 21 days for 18 cycles.

Dexamethasone - oral 4mg tablets for a total dose of 20mg or 40 mg given days 1,8,15 and 22 of each 28 day cycle for 18 cycles intervention 3: Melphalan - oral, 2mg tablets dosed at either 0.25mg/kg, 0.125 mg/kg, 0.20mg/kg or 0.10mg/kg on days 1-4 of each 42 day cycle up to 12 cycles Prednisone - oral, 5mg, 10mg, 20 mg and 50 mg tablets dosed at 2mg/kg daily days 1-4 of each 42 day cycle for up to 12 cycles Thalidomide - oral, 50mg, 100mg and 200 mg capsules dosed at either 100mg or 200 mg daily on days 1-41 of each 42 day cycle for up to 12 cycles

Protocol document: