MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

259

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

April 30, 2011

Study Completion Date

September 30, 2015

Conditions
Multiple Myeloma
Interventions
DRUG

Pomalidomide

1 mg, 2 mg, and 5 mg capsules for oral administration packaged in bottles containing a 21-day supply

DRUG

Dexamethasone

oral dexamethasone

DRUG

Aspirin

As prophylactic anti-thrombotic treatment, all participants were given aspirin 81-100 mg daily (commercial supply) unless contraindicated. If aspirin was contraindicated, participants were given another form of anti-thrombotic therapy according to hospital guidelines or physician preference.

Trial Locations (19)

10029

Mt. Sinai Hospital, New York

14263

Roswell Park Cancer Institute Department of Medicine, Buffalo

15232

University of Pittsburgh, Pittsburgh

30322

Winship Cancer Institute of Emory University, Atlanta

33612

Moffitt Cancer Center, Tampa

48109

University of Michigan Comprehensive Cancer CenterDivision of Hematology/Oncology, Ann Arbor

55905

Mayo Clinic - Arizona, Rochester

63110

Washington University School of Medicine, St Louis

80218

Colorado Blood Cancer Institute, Denver

85259

Mayo Clinic Arizona, Scottsdale

02114

Mass General Hospital, Boston

02115

Dana-Farber Cancer Institute, Boston

07601

The Cancer Center at Hackensack University Medical Center, Hackensack

43210-1240

Ohio State University Arthur G. James Cancer Hospital, Columbus

T2N 2T9

Tom Baker Cancer Center, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

V5Z 1M9

Vancouver General Hospital, Vancouver

M5G 2M9

Princess Margaret Hospital and University of Toronto, Toronto

H3A 1A1

Royal Victoria Hosptial, Montreal

Sponsors
All Listed Sponsors
lead

Celgene Corporation

INDUSTRY