158
Participants
Start Date
August 31, 2007
Primary Completion Date
October 31, 2010
Study Completion Date
November 30, 2010
VELCADE (bortezomib)
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).
dexamethasone
dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop
cyclophosphamide
cyclophosphamide 500 mg/m\^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop
Revlimid (lenalidomide)
"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)"
Rocky Mountain Cancer Center, Denver
Mayo Clinic, Rochester
Lead Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Millennium Pharmaceuticals, Inc.
INDUSTRY