A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

July 2, 2018

Primary Completion Date

July 31, 2026

Study Completion Date

July 31, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

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

DRUG

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

DRUG

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

DRUG

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."

PROCEDURE

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.

Trial Locations (12)

10010

New York University, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11030

Northwell Health, Manhasset

11553

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack

27109

Wake Forest University (Data Collection Only), Winston-Salem

35294

University of Alabama Comprehensive Cancer Center, Birmingham

53226

Medical College of Wisconsin (Data Collection Only), Milwaukee

07920

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER