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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

February 29, 2012

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Multiple Myeloma
Interventions
DRUG

Pomalidomide

Pomalidomide administered to 3 cohorts of subjects at escalating doses of 2 (cohort 1), 3 (cohort 2) and 4 mg/dose (cohort 3) per orem (PO). Doses are to be administered once-a-day, for the first 21 days, as part of a 28-day treatment cycle, followed by a 7-day rest period.

DRUG

Pegylated Liposomal Doxorubicin (PLD)

"Dexamethasone will be given at a dose of 40 mg/dose IV. Doses are to be administered on days 1, 4, 8, and 11 of the 28-day cycle.~PLD will be given at a dose of 5.0 mg/m2 as a 60 minute IV 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."

DRUG

Dexamethasone

Dexamethasone will be given at a dose of 40 mg/dose IV. Doses are to be administered on days 1, 4, 8, and 11 of the 28-day cycle.

Trial Locations (8)

60714

Illinois Cancer Specialists, Niles

90069

James R Berenson, MD, Inc., West Hollywood

91505

Roy and Patricia Disney Family Cancer Center, Burbank

92024

California Cancer Associates for Research and Excellence, Encinitas

93105

Cancer Center of Santa Barbara, Santa Barbara

93454

Mission Hope Cancer Center, Santa Maria

93720

Hematology Oncology Medical Group, Fresno

93901

Pacific Cancer Care, Salinas

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

Oncotherapeutics

INDUSTRY