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OncoMatch/Clinical Trials/NCT05438043

A Study of Daratumumab

Is NCT05438043 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments for multiple myeloma.

Phase 3RecruitingJanssen Research & Development, LLCNCT05438043Data as of Jun 2026Location: International · 16 countries

Treatment: Daratumumab · Carfilzomib · Dexamethasone · Lenalidomide · PomalidomideThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Daratumumab

Targeted therapy

Carfilzomib

Endocrine / hormonal

LenalidomidePomalidomide

Other

Dexamethasone

Cancer type

Multiple Myeloma

Prior therapy

Must have received: daratumumab (daratumumab) — parent Janssen R&D daratumumab study

Participants must be actively receiving daratumumab (either as monotherapy or in combination with other study treatment) in certain Janssen research and development (R&D) studies or receiving other study treatment in a Janssen R&D daratumumab study for participants with multiple myeloma or smoldering multiple myeloma which has reached clinical cutoff for final analysis continue to benefit from study treatment, not have experienced disease progression or unmanageable toxicity while receiving daratumumab, not have met the withdrawal criteria set forth in the parent study, and have had the last dose of study treatment within the previous 3 months

Cannot have received: disallowed therapies or treatment for the disease under study

Has taken any disallowed therapies or treatment for the disease under study between the completion of the parent study and the planned first dose of study treatment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Miami Sylvester Cancer Center · Miami, Florida
  • Emory University · Atlanta, Georgia
  • University of Michigan Comprehensive Cancer Center · Ann Arbor, Michigan
  • Barnes-jewish Hospital · St Louis, Missouri
  • Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg · New York, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT05438043 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior disallowed therapies or treatment for the disease under study disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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