CARTITUDE-10
Multiple myeloma
A Phase 2 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 0–1
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 will be administered.
Cilta-cel, ciltacabtagene autoleucel; 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; ND, newly diagnosed; OS, overall survival; PFS, progression-free survival.