Pegylated Liposomal Doxorubicin, Bortezomib, Dexamethasone and Lenalidomide for Relapsed/Refractory Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

December 31, 2011

Study Completion Date

September 30, 2012

Conditions
Multiple Myeloma
Interventions
DRUG

DVD-R

40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.

Trial Locations (8)

13326

Bassett Cancer Institute, Cooperstown

13790

Broome Oncology, Johnson City

33805

Watson Clinic, LLP, Center for Care and Research, Lakeland

90069

James R. Berenson, M.D., Inc., West Hollywood

92354

Loma Linda University, Loma Linda

93105

Santa Barbara Hematology Oncology, Santa Barbara

93309

Comprehensive Blood and Cancer Center, Bakersfield

93720

Hematology-Oncology Medical Group of Fresno, Inc., Fresno

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Oncotherapeutics

INDUSTRY