45
Participants
Start Date
July 21, 2011
Primary Completion Date
July 10, 2016
Study Completion Date
September 24, 2020
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
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
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
Lenalidomide
After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles
Lenalidomide
After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda
Collaborators (2)
Celgene
INDUSTRY
Onyx Therapeutics, Inc.
INDUSTRY
National Cancer Institute (NCI)
NIH