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

Part of paid clinical trials in Chicago, Illinois.

Sponsor: University of Chicago
Study ID: NCT03500445
Phase: PHASE2
Status: Active Not Recruiting

Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Daratumumab — DRUG
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
Carfilzomib — DRUG
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
Lenalidomide — DRUG
Lenalidomide will be taken orally as follows: • Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21
Dexamethasone — DRUG
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

Study Details

The purpose of this study is to determine response rate after 8 cycles of D-KRd (daratumumab, carfilzomib, lenalidomide (Revlimid) and dexamethasone in patients with multiple myeloma.