NCT04176718

Daratumumab, Carfilzomib, Pomalidomide, Dexamethasone In MM

A Phase II Study of Daratumumab With Weekly Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed and Refractory Multiple Myeloma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Andrew Yee, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying the combination of daratumumab with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma. Relapsed and Refractory Multiple Myeloma is the condition of returned or previous treatment resistant Multiple Myeloma. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: * Carfilzomib * Daratumumab * The names of the standard of care drugs involved in this study are: * Dexamethasone * Pomalidomide

Detailed description

This phase II, multicenter, open-label study is studying daratumumab in combination with weekly carfilzomib, pomalidomide, and dexamethasone in people with relapsed and refractory multiple myeloma who have received at least one prior therapy and who have had previous treatment with both lenalidomide and a proteasome inhibitor. * The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. This research study involves two study drugs and two standard of care drugs. * The names of the study drugs involved in this study are: * Carfilzomib * Daratumumab * The names of the standard of care drugs involved in this study are: * Dexamethasone * Pomalidomide * A total of 43 participants will be enrolled to this trial * The U.S. Food and Drug Administration (FDA) has not approved Daratumumab, and Carfilzomib for use in treatment of Multiple Myeloma.

Conditions

• Multiple Myeloma
• Refractory Multiple Myeloma
• Multiple Myeloma in Relapse
• Relapse

Interventions

Type	Name	Description
DRUG	Daratumumab	predetermined dose, intravenously, at predetermined times per cycle
DRUG	Carfilzomib	predetermined dose, intravenously, give 3 times per cycle
DRUG	Pomalidomide	predetermined dose, orally, daily per cycle
DRUG	Dexamethasone	predetermined dose, orally, given 8 times per cycle

Timeline

• Start date: 2020-05-18
• Primary completion: 2027-05-01
• Completion: 2028-05-01
• First posted: 2019-11-25
• Last updated: 2025-10-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study