Phase 1/2 Study of VELCADE® in Combination With Other Drugs to Treat Previously Untreated Multiple Myeloma Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

October 31, 2010

Study Completion Date

November 30, 2010

Conditions
Multiple Myeloma
Interventions
DRUG

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).

DRUG

dexamethasone

dexamethasone 40 mg orally on days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop

DRUG

cyclophosphamide

cyclophosphamide 500 mg/m\^2 orally on days 1 and 8 of a 3-week cycle for 8 cycles, then stop

DRUG

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)"

Trial Locations (2)

80218

Rocky Mountain Cancer Center, Denver

55904-0001

Mayo Clinic, Rochester

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Millennium Pharmaceuticals, Inc.

INDUSTRY