Revlimid / All-Trans Retinoic Acid (ATRA) / Dexamethasone in Relapsed/Refractory Multiple Myeloma

PHASE1TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Myeloma
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER