Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

February 13, 2019

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
MyelomaMultiple Myeloma
Interventions
DRUG

Daratumumab

"Daratumumab (16 mg/kg) will be administered as an IV infusion:~* Cycle 1-2: 16 mg/kg weekly~* Cycles 3-8: 16 mg/kg IV infusion every 2 weeks~* Cycles 9-24: 16 mg/kg IV infusion Day 1"

DRUG

Carfilzomib

"Carfilzomib will be given as an IV infusion over 30 minutes:~* 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 allowed at the treating physician's discretion.~* Cycle 2-9: 36 mg/m2 (or best tolerated dose) Days 1, 2, 8, 9, 15 and 16~* Cycles 9-24: 36 mg/m2 (or best tolerated dose) Days 1, 2, 15 and 16"

DRUG

Lenalidomide

"Lenalidomide will be taken orally as follows:~• Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21"

DRUG

Dexamethasone

"Dexamethasone will be administered prior to carfilzomib (on days that they coincide), as follows:~* Cycles 1-9: 40 mg PO (subjects ≤ 75 years) or 20 mg PO (subjects ≥ 75 years) per week~* Cycles 9-24: 20 mg PO per week~During weeks when daratumumab is given: 40 mg dexamethasone weekly, 20 mg prior to daratumumab infusion and 20 mg PO the day after~During weeks with no daratumumab, single dose of 20 mg on day 1"

Trial Locations (1)

60637

The University of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Janssen Scientific Affairs, LLC

INDUSTRY

collaborator

Amgen

INDUSTRY

lead

University of Chicago

OTHER