18
Participants
Start Date
August 31, 2008
Primary Completion Date
December 31, 2012
Study Completion Date
May 31, 2014
Lenalidomide Induction
Induction: Lenalidomide 25 mg daily on Days 1-21 followed by 7 day rest and Dexamethasone 40 mg by mouth (po) daily on Days 1, 8, 15 and 22 every 28 days for 4 cycles.
Sequential Maintenance Therapy
"Subjects who achieve \>partial response (PR) following induction therapy will receive repeating triplet cycles of alternating low dose therapy until progression, poor tolerance or toxicity. Subjects who complete 24 months of maintenance will be removed from study unless they achieved \> stable disease (SD) from maintenance (per discussion with physician):~* 325 mg aspirin for deep vein thrombosis (DVT) prophylaxis~* Cycle 1, 4, 7, etc. - bortezomib 1.3 mg/m2 on day 1 and 8 of a 28-day cycle~* Cycle 2, 5, 8 etc. - Melphalan 6 mg/m2 by mouth (po) daily on Days 1-7~* Prednisone 60 mg /m2 po daily on Days 1-7 of a 28-day cycle~* Cycle 3, 6, 9, etc. Lenalidomide 10 mg po daily on Days 1-21 of a 28 day cycle."
Duke University Medical Center, Durham
Collaborators (1)
Celgene Corporation
INDUSTRY
Cristina Gasparetto
OTHER