A Study of Daratumumab in Patients With Newly Diagnosed Multiple Myeloma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

September 25, 2017

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Multiple Myeloma
Interventions
DRUG

daratumumab

Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.

DRUG

carfilzomib

Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16

DRUG

lenalidomide

Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days

DRUG

dexamethasone

Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16

DRUG

dexamethasone

Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11553

Memorial Sloan Kettering Nassau, Uniondale

11725

Memorial Sloan Kettering Commack, Commack

07920

Memorial Sloan Kettering Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

07645

Memorial Sloan Kettering Bergen, Montvale

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Pharmaceuticals

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER