Clinical Trial

A Study of Daratumumab

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 changes
minor Completion pushed: 2029-01-31 -> 2029-12-31 2026-06-06
notable Trial sites expanded: 88 -> 91 locations 2026-04-14
Trial Details
NCT Number NCT05438043
Lead Sponsor Janssen Research & Development, LLC
Conditions Multiple Myeloma
Enrollment 500 participants
Start Date 2022-12-15
Primary Completion 2029-01-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-05