Event Item #1
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Active

Clinical Trial

CMRG 013/EMN28

Summary

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.

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel (CAR-T) versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

Objective

To evaluate progression free survival is defined as the time from the date of randomization to the date of first documented PD, as defined in the IMWG criteria, or death due to any cause, whichever occurs first

Eligibility Criteria

Inclusion Criteria

  1. Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
  2. 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.
  3. ECOG performance status of grade 0 or 1
  4. Clinical laboratory values within prespecified range.

Exclusion Critera

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