Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Myeloma
Interventions
DRUG

Pomalidomide

Pomalidomide at 4 mg by mouth (PO) as outlined in the treatment arms.

DRUG

Dexamethasone

Dexamethasone at 40 mg (20 mg) PO as outlined in the treatment arms.

DRUG

Cyclophosphamide

"The dose escalation uses a standard 3x3 design: Ex: If none of the first 3 participants have a DLT, enter 3 participants at the next higher dose level. Once the maximum tolerated dose (MTD) of oral weekly cyclophosphamide in combination with pomalidomide and dexamethasone was determined, investigators proceeded with the second phase of the trial, a randomized phase II study comparing pomalidomide and dexamethasone with pomalidomide, dexamethasone and oral weekly cyclophosphamide delivered at the MTD determined in the phase I study."

Trial Locations (3)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

94143

University of California San Francisco, San Francisco

10029-6574

Mount Sinai School of Medicine, The Tisch Cancer Institute, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER