587
Participants
Start Date
November 30, 2006
Primary Completion Date
October 31, 2009
Study Completion Date
November 30, 2009
Lenalidomide
Oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days. Treatment as tolerated until disease progression, drug became commercially available or limited to 6 treatment cycles.
Dexamethasone
Oral pulse dexamethasone at a dose of 40 mg daily on days 1-4, 9-12, and 17-20 for each 28-day-cycle for cycles 1 through 4. Beginning cycle 5, a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Wilhelminenspital, Vienna
The Mater Private Centre for Haematology & Oncology, South Brisbane
St James's Hospital, Dublin
H. Clínico de Salamanca, Salamanca
Royal Free Hospital & Medical School, London
Lead Sponsor
Celgene Corporation
INDUSTRY