2
Participants
Start Date
December 31, 2013
Primary Completion Date
September 30, 2015
Study Completion Date
September 30, 2015
Lenalidomide
"Phase I All Patients - Induction: Lenalidomide starting dose 25 mg by mouth 1 time every day on Day 1-21.~Phase II Group A: Lenalidomide starting dose: Dose tolerated prior to enrollment.~Maintenance Therapy: Phase I and Phase II Group A: Maintenance therapy lenalidomide at dose level tolerated at completion of cycle 3 for 21/28 days.~Phase II Group B: Lenalidomide will be given as a single oral dose at the level patient was on at the time of progression on single agent lenalidomide prior to study enrollment."
Dexamethasone
"Phase I All Patients - Induction: Dexamethasone starting dose 40 mg by mouth on Days 1,8,15,22.~Phase II Group A: Dexamethasone starting dose: Dose previously on when progressing prior to study entry.~Maintenance Therapy: Phase I and Phase II Group A: Dexamethasone at last tolerated dose on Days 1, 8, 15 and 22."
All-Trans Retinoic Acid (ATRA)
"Phase I All Patients - Induction: ATRA starting dose 25 mg/m2 by mouth 2 times each day on Days 1-21.~Phase II Group A: ATRA starting dose: MTD from Phase I.~Maintenance Therapy: Phase I and Phase II Group A: ATRA at dose determined in Phase I for 14/28 days.~Phase II Group B: All-Trans Retinoic Acid (ATRA) starting dose: MTD from Phase I.~Maintenance Therapy Group B: ATRA at the dose determined in the Phase I portion of the trial for 14/28 days."
University of Texas MD Anderson Cancer Center, Houston
Collaborators (1)
Celgene Corporation
INDUSTRY
M.D. Anderson Cancer Center
OTHER