180
Participants
Start Date
April 26, 2016
Primary Completion Date
November 30, 2025
Study Completion Date
November 30, 2026
Lenalidomide
"* Cycle 1: 15 mg days 1-21~* Cycles 2-4: 25 mg days 1-21 if tolerated, otherwise continue at lower dose~* Cycles 5 and beyond: best tolerated dose days 1-21"
Carfilzomib
"* Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8,9 of cycle 1) will be al12,lowed at the treating physician's discretion.~* Cycle 2-4: 36 mg/m2 if tolerated Days 1, 2, 8, 9, 15, 16~* Cycles 5-8 (patients that are MRD- and have no risk factors at the end of cycle 6) and Cycle 5 - 36 (for MRD+ patients and high risk patients at the end of cycle 6): best tolerated dose Days 1, 2, 15, 16"
Dexamethasone
"* Cycles 1 - 4: 20 mg PO or IV per dose Days 1, 8, 15, 22~* Cycles 5+: 20 mg or best tolerated dose PO or IV per dose Days 1, 8, 15, 22"
Lenalidomide (Control)
"* Cycles 1-4: Days 1-28. Lenalidomide will begin at a dose of 10 mg PO daily (2 capsules per day). After three months, the dose will be increased, provided ANC ≥ 1,000/µL, platelet count ≥ 75,000/µL, and all nonhematologic toxicity is ≤ grade 1, to 15 mg PO daily (3 capsules per day).~* Cycles 5 and beyond: best tolerated dose days 1-28"
Wayne State University - Karmanos Cacner Institute, Detroit
University of Chicago, Chicago
Polish Myeloma Consortium, Poznan
University of Chicago
OTHER