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Comparing two treatments for newly diagnosed multiple myeloma

A Phase 3 Randomized Study Comparing Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible

PHASE3 · European Myeloma Network B.V. · NCT05257083

This study is testing if a new CAR-T therapy can help people with newly diagnosed multiple myeloma live longer without their disease getting worse compared to the traditional stem cell transplant method.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorEuropean Myeloma Network B.V. (network)
Drugs / interventionsCAR-T, Daratumumab, chimeric antigen receptor
Locations109 sites (Little Rock, Arkansas and 108 other locations)
Trial IDNCT05257083 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a treatment regimen combining Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel against the same regimen followed by Autologous Stem Cell Transplant (ASCT) in patients with newly diagnosed multiple myeloma. Approximately 750 participants will be randomly assigned to one of the two treatment arms to assess progression-free survival and the rate of sustained minimal residual disease-negative complete response. The study seeks to determine if the CAR-T therapy can provide better outcomes compared to traditional stem cell transplant methods.

Who should consider this trial

Good fit: Ideal candidates are individuals with newly diagnosed multiple myeloma who are eligible for high-dose therapy and ASCT.

Not a fit: Patients who have previously received CAR-T therapy or any BCMA-targeted therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes and longer progression-free survival for patients with newly diagnosed multiple myeloma.

How similar studies have performed: Other studies have shown promise with CAR-T therapies in treating multiple myeloma, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
* Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:

  1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
  2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
* ECOG performance status of grade 0 or 1
* Clinical laboratory values within prespecified range.

Exclusion Criteria:

* Prior treatment with CAR-T therapy directed at any target.
* Any prior BCMA target therapy.
* Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
* Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
* Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
* Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
* Stroke or seizure within 6 months of signing Informed Consent Form (ICF)

Where this trial is running

Little Rock, Arkansas and 108 other locations

+59 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 →

Conditions: Multiple Myeloma, Cellular Therapy, CAR-T Therapy, BCMA CAR-T, Newly Diagnosed Multiple Myeloma

Last reviewed 2026-05-15 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.