Celgene High Risk Multiple Myeloma (MM) Revlimid Induction and Maintenance Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

December 31, 2012

Study Completion Date

May 31, 2014

Conditions
Multiple Myeloma
Interventions
DRUG

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.

DRUG

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."

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Cristina Gasparetto

OTHER