CARTITUDE-10
Multiple myeloma
A Phase 2, open-label study of cilta-cel (anti-BCMA CAR T-cell therapy) in participants with MM
Phase
Compound
Cilta-cel (anti-BCMA CAR T-cell therapy) + cyclophosphamide + induction therapy
NCT identifier
NCT07149857
Enrollment
N=~60
For more information, including
contact details, please visit
the J&J Clinical Trial Finder
contact details, please visit
the J&J Clinical Trial Finder
Study overview & design
Key eligibility criteria*:
- ND MM according to IMWG and measurable disease at diagnosis
- Not considered a candidate for high-dose chemotherapy with stem cell transplantation
- ≥3 cycles and ≤5 cycles of induction therapy
- ECOG PS 0 or 1
Study
design
Primary outcomes:
- MRD-negative CR
Secondary outcomes†:
- Overall MRD-negative CR
- ≥CR
- PFS
- OS
- Safety
- Anti-cilta-cel antibodies
*Not a complete list of inclusion criteria. †Bortezomib, lenalidomide, and dexamethasone (VRd) or
daratumumab, lenalidomide, and dexamethasone (DRd) or daratumumab, bortezomib, lenalidomide, and dexamethasone
(DVRd), will be administered. †Not a complete list of outcomes.
BCMA, B-cell maturation antigen;
cilta-cel, ciltacabtagene autoleucel; CAR, chimeric antigen receptor; CR, complete response; ECOG PS, Eastern
Cooperative Oncology Group performance status; IMWG, International Myeloma Working Group; IV, intravenous; MM,
multiple myeloma; MRD, minimal residual disease; NDMM, newly diagnosed multiple myeloma; OS, overall survival; PFS,
progression-free survival.