Carfilzomib, Lenalidomide, and Dexamethasone in New Multiple Myeloma Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 21, 2011

Primary Completion Date

July 10, 2016

Study Completion Date

September 24, 2020

Conditions
Multiple Myeloma
Interventions
DRUG

Carfilzomib

Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16

DRUG

Lenalidomide

Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year

DRUG

Dexamethasone

Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22, and 23 Cycle 2-4: 20 mg oral or IV on days 1, 2, 8, 9, 15, 16, 22, and 23 Cycle 5-8: 10 mg oral or IV on days 1, 2, 8, 9, 15, 16, 22, and 23

DRUG

Lenalidomide

After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles

DRUG

Lenalidomide

After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year

Trial Locations (1)

20892

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda

Sponsors
All Listed Sponsors
collaborator

Celgene

INDUSTRY

collaborator

Onyx Therapeutics, Inc.

INDUSTRY

lead

National Cancer Institute (NCI)

NIH