Phase 3 Myeloma Trial, Recruiting NCT05438043 Sponsor: Janssen Research & Development, LLC Condition: Myeloma
Back to Myeloma

Phase 3 Myeloma Trial, Recruiting

NCT05438043
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are currently taking daratumumab (either alone or combined with other study treatments) or other study treatments in a qualifying Janssen research study for multiple myeloma or smoldering multiple myeloma, where that study has reached its final analysis stage, and who are still benefiting from the treatment
  • People who have not had their disease get worse, have not had unmanageable side effects, and have received their last dose of study treatment within the past 3 months
  • People whose doctor believes the benefits of continuing the study treatment outweigh the risks
  • Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to further pregnancy tests during the study
  • Men must agree not to donate sperm for reproduction during the study and for at least 3 months after the last dose of study treatment
  • People who have signed a consent form (or had their legal representative sign) showing they understand the study and are willing to take part
  • People who are willing and able to follow the lifestyle requirements set out in the study plan

Who may not be able to join:

  • People who received any treatments not allowed by the study, or treatments for their disease, between finishing the original (parent) study and the planned start of study treatment
  • People with any condition that, in the treating doctor's opinion, would make participation unsafe or not in their best interest, or that could interfere with the study assessments
  • People with known allergies or sensitivities to any of the study treatments or their ingredients, including daratumumab, dexamethasone, carfilzomib, pomalidomide, or lenalidomide
  • People who received a non-COVID-19 investigational vaccine, or a live or replicating viral vaccine, within 4 weeks before enrolling in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
15 December 2022
Est. completion
31 January 2029

Where this trial is recruiting

🇧🇪 Belgium 🇧🇷 Brazil 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇺🇦 Ukraine 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of Participants with Serious Adverse Events (SAEs); Number of Participants with AEs of Special Interest (AESI); Number of Participants with Pregnancies or Partner Pregnancies; Number of Participants with Abnormal Pregnancies as SAE

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov