CARTITUDE-6
A Study 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 Participants With Newly Diagnosed Multiple Myeloma (CARTITUDE-6)
What will happen during the trial?
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.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 3
- Enrollment
- 750 patients (estimated)
- Sponsors
- European Myeloma Network
- Collaborators
- Janssen Research & Development LLC
- Tags
- Autologous Stem Cell Transplant, CAR T Cell, B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- 1 week ago
- SparkCures ID
- 1303
- NCT Identifier
- NCT05257083
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