Conditions: Multiple Myeloma
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 5
Healthy volunteers: no

Brief summary:
This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Detailed description:
A new drug (bortezomib \[VelcadeTM PS-341\]) has been shown in recent studies to be effective in subjects with advanced multiple myeloma. There is also research that shows this drug may be even more effective when used in combination with other drugs that have been used to treat myeloma for many years (melphalan, thalidomide, and dexamethasone). This study is being done to find out if the combination of VelcadeTM with melphalan and dexamethasone (VMD) will be as effective, or even more effective as it is in combination with thalidomide and dexamethasone (VTD).

Arms:
arm 1: VTD = Velcade, Thalidomide, and Dexamethasone arm 2: VMD = velcade, melphalan, and dexamethasone

Interventions: intervention 1: Velcade, Thalidomide, and Dexamethasone intervention 2: Velcade, Melphalan, and Dexamethasone
Intervention descriptions: intervention 1: Velcade - Into vein (IV) Days 1, 4, 8, 11

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles

Thalidomide - By Mouth Days 1-28

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles intervention 2: Velcade - Into vein (IV) Days 1, 4, 8, 11

Yr 1: Every 28-35 days-12 cycles

Yr 2: Every 8-10 weeks- 6 cycles

Protocol document: