NCT05438043

A Study of Daratumumab

A Phase 3b, Multicenter, Open-label, Daratumumab Long-term Extension Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Daratumumab	Daratumumab will be administered either intravenously or subcutaneously.
DRUG	Carfilzomib	Carfilzomib will be administered intravenously.
DRUG	Dexamethasone	Dexamethasone will be administered either orally or intravenously.
DRUG	Lenalidomide	Lenalidomide will be administered orally.
DRUG	Pomalidomide	Pomalidomide will be administered orally.

Timeline

• Start date: 2022-12-15
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2022-06-29
• Last updated: 2026-04-13

Locations

91 sites across 17 countries: United States, Belgium, Brazil, China, Czechia, Denmark, France, Germany, Greece, Italy, Poland, Russia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study