Study to Determine the Maximum Tolerated Dose for the Combination of Pomalidomide, Bortezomib and Low-Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 15, 2012

Primary Completion Date

July 23, 2019

Study Completion Date

July 23, 2019

Conditions
Multiple Myeloma
Interventions
DRUG

Pomalidomide

Pomalidomide 1, 2, 3, or 4 mg will be taken orally on Days 1-14 of a 21-day cycle

DRUG

Bortezomib

Bortezomib 1 or 1.3 mg/m2 will be administered intravenously or subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression

DRUG

Dexamethasone

Dexamethasone 20 mg/day \[≤ 75 years old\] or 10 mg/day \[\> 75 years old\] will be taken orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression

Trial Locations (6)

30322

Winship Cancer Institute of Emory University, Atlanta

43210

Ohio State University Medical Center, Columbus

02114

Massachusetts General Hospital, Boston

02115-6084

Dana-Farber Cancer Institute, Boston

02215

Beth Israel Deaconess Medical Center, Boston

07601

Hackensack University Medical Center, Hackensack

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Multiple Myeloma Research Consortium

NETWORK

lead

Celgene

INDUSTRY