NCT03500445

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

Open-label, Single-arm, Phase 2 Study of Initial Treatment With Daratumumab (Darzalex), Carfilzomib (Kyprolis), Lenalidomide (Revlimid) and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myeloma
• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-02-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2018-04-18
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study