80
Participants
Start Date
November 30, 2011
Primary Completion Date
August 31, 2016
Study Completion Date
August 31, 2016
Pomalidomide
Pomalidomide at 4 mg by mouth (PO) as outlined in the treatment arms.
Dexamethasone
Dexamethasone at 40 mg (20 mg) PO as outlined in the treatment arms.
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."
H. Lee Moffitt Cancer Center and Research Institute, Tampa
University of California San Francisco, San Francisco
Mount Sinai School of Medicine, The Tisch Cancer Institute, New York
Collaborators (1)
Celgene
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER