Study of Carfilzomib for Multiple Myeloma Patients Who Are Relapsed/Refractory to Bortezomib-containing Treatments

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 2, 2011

Primary Completion Date

June 13, 2014

Study Completion Date

March 1, 2016

Conditions
Multiple Myeloma
Interventions
DRUG

Group A: Carfilzomib & Non-IMiD Regimen

"Carfilzomib will be administered intravenously starting at a dose of 20 mg/m\^2 over 30 minutes for the first cycle and will then be increased to 27, 36 and 45 mg/m2 during cycles 2-4, respectively. Doses will be administered IV once daily on days 1, 2, 8, 9, 15, and 16 of each cycle. Cycles will be 28 days in length.~Combination non-IMiD drug is dosed on the identical schedule and dosage as patient was in previous bortezomib containing regimen.~Maintenance regimen maybe administered if patient does not progress while on study."

DRUG

Group B: Carfilzomib & IMiD containing regimen.

"Carfilzomib will be administered intravenously starting at a dose of 20 mg/m\^2 over 30 minutes for the first cycle and will then be increased to 27, 36 and 45 mg/m2 during cycles 2-4, respectively. Doses will be administered IV once daily on days 1, 2, 8, 9, 15, and 16 of each cycle. Cycles will be 28 days in length.~Combination IMiD drug is dosed on the identical schedule and dosage as patient was in previous bortezomib containing regimen.~Maintenance regimen maybe administered if patient does not progress while on study."

Trial Locations (9)

20817

Center for Cancer and Blood Disorders, Bethesda

38119

Family Cancer Center Foundation, Inc., Memphis

46237

Franciscan St. Francis Health, Indianapolis

60099

Cancer Centers of America, Zion

90069

James R. Berenson, MD, Inc., West Hollywood

92024

Pacific Oncology and Hematology, Encinitas

93454

Central Coast Medical Oncology, Santa Maria

93901

Pacific Cancer Care, Salinas

233031

Virginia Cancer Specialists, Fairfax

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

Oncotherapeutics

INDUSTRY