A Multicenter, Open-label, Phase 1b Study of Carfilzomib, Cyclophosphamide and Dexamethasone in Newly Diagnosed Multiple Myeloma Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Multiple Myeloma
Interventions
DRUG

Carfilzomib

Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².

DRUG

Cyclophosphamide

Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.

DRUG

Dexamethasone

Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.

Trial Locations (9)

Unknown

California Cancer Associates for Research and Excellence, Encinitas

James R. Berenson, MD, West Hollywood

The Oncology Institute of Hope and Innovation, Whittier

Horizon Oncology Research, Lafayette

Center for Cancer and Blood Disorders, Bethesda

Clinical Research Alliance, New York

Tennessee Oncology, Nashville

Texas Oncology, Austin

Virginia Oncology Associates, Norfolk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY