Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to compare the efficacy of 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 newly diagnosed multiple myeloma patients.

Official Title

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

Details

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function.

JNJ-68284528 (ciltacabtagene autoleucel [cilta-cel]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT).

Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

Keywords

Multiple Myeloma, Cellular Therapy, CAR-T Therapy, BCMA CAR-T, Newly Diagnosed Multiple Myeloma, Plasma Cell Neoplasms, Dexamethasone, Cyclophosphamide, Fludarabine, Lenalidomide, Bortezomib, Daratumumab, Cilta-cel, DVRd followed by Ciltacabtagene Autoleucel

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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)

Locations

  • UCSF (UCSF) not yet accepting patients
    San Francisco California 94143 United States
  • Stanford University not yet accepting patients
    Stanford California 94305 United States
  • Oslo University Hospital Ullevål - Oncology accepting new patients
    Oslo Norway
  • VU Medisch Centrum accepting new patients
    Amsterdam Netherlands
  • University Medical Center Groningen accepting new patients
    Groningen Netherlands
  • Radboud UMC not yet accepting patients
    Nijmegen Netherlands
  • Erasmus MC accepting new patients
    Rotterdam Netherlands
  • UMC Utrecht not yet accepting patients
    Utrecht Netherlands

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Stichting European Myeloma Network
ID
NCT05257083
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 750 study participants
Last Updated