41
Participants
Start Date
July 2, 2018
Primary Completion Date
July 31, 2026
Study Completion Date
July 31, 2026
Carfilzomib
Dara-CRd Induction Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 1 and 2; Carfilzomib 27 mg/m2 per dose, days 8, 9, 15, and 16 Cycles 2-4: Carfilzomib 27 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16 Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Carfilzomib 27 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
Lenalidomide
Dara-CRd Induction Cycles 1-4: Lenalidomide 25 mg/day, days 1-21 every 28 days Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
Dexamethasone
Dara-CRd Induction Cycles 1-4: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, 23 Dara-CRd Consolidation (60-90 days post HCT) Cycles 5-8: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, 23
Daratumumab
"Dara-CRd Induction Cycles 1 and 2: Daratumumab 16 mg/kg weekly (days 1,8, 15, 22) Dara-CRd Consolidation (60-90 days post HCT)~Cycles 3 and 4: Daratumumab 16 mg/kg every other week, days 1 and 15.~Cycles 5-6:Daratumumab 16 mg/kg every other week, days 1 and 15. Schedule together with Carfilzomib and use scheduled dexamethasone as premed.~Cycles 7-8: Daratumumab 16 mg/kg days 1 of each cycle."
autologous hematopoietic cell transplantation
High Dose Melphalan and Autologous Hematopoietic Cell Transplantation Patients will receive Melphalan 200 mg/m2 per institutional guidelines, or if over 70 years of age or creatinine \>2mg/dL, they will receive 140 mg/m2.
New York University, New York
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
Northwell Health, Manhasset
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack
Wake Forest University (Data Collection Only), Winston-Salem
University of Alabama Comprehensive Cancer Center, Birmingham
Medical College of Wisconsin (Data Collection Only), Milwaukee
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Collaborators (1)
Janssen Pharmaceuticals
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER