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Access to daratumumab treatment for multiple myeloma patients

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

Phase 3 Interventional Janssen Research & Development, LLC · NCT05438043

This study is testing whether patients with multiple myeloma can keep receiving the drug daratumumab if it's helping them, while also tracking how safe it is over time.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsdaratumumab
Locations91 sites (Miami, Florida and 90 other locations)
Trial IDNCT05438043 on ClinicalTrials.gov

What this trial studies

This study aims to provide ongoing access to daratumumab for participants with multiple myeloma or smoldering multiple myeloma who are benefiting from treatment in specific Janssen Research and Development studies. Participants will continue to receive daratumumab, either alone or in combination with other treatments, as long as they have not experienced disease progression or unmanageable toxicity. The study will also collect long-term safety data from participants receiving the treatment. This approach allows for continued care and monitoring of patients who have shown positive responses to daratumumab.

Who should consider this trial

Good fit: Ideal candidates are patients currently receiving daratumumab in related studies who have not experienced disease progression or severe side effects.

Not a fit: Patients who have not been treated with daratumumab or those who have experienced significant toxicity or disease progression while on treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could ensure continued access to effective treatment for patients with multiple myeloma.

How similar studies have performed: Other studies involving daratumumab have shown promising results in treating multiple myeloma, indicating a potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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
* Investigator's assessment that the benefit of continued study treatment will outweigh the risks
* A female participant of childbearing potential must have a negative pregnancy test at screening and must agree to further serum or urine pregnancy tests during the study
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 3 months after receiving the last dose of study treatment
* Must sign an informed consent form (ICF; or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* Willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion Criteria:

* 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
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
* Known allergies, hypersensitivity, or intolerance to study treatments or their excipients (refer to the daratumumab investigator brochure (IB) and local country prescribing information for dexamethasone, carfilzomib, pomalidomide, and lenalidomide)
* Vaccinated with an investigational vaccine (except for Coronavirus disease \[COVID-19\])or live attenuated or replicating viral vector vaccines within 4 weeks prior to enrollment

Where this trial is running

Miami, Florida and 90 other locations

+41 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.