
Cilta-Cel Outcomes in R/R Multiple Myeloma: Omar Castaneda Puglianini, MD
Therapy Status
Carvykti (ciltacabtagene autoleucel)
Johnson & Johnson / Legend Biotech
Approved for relapsed/refractory multiple myeloma after at least 1 prior line of therapy (lenalidomide-refractory). Boxed warnings cover CRS, ICANS, Parkinsonism/GBS, HLH/MAS, prolonged cytopenias, immune effector cell-associated enterocolitis (added October 2025), and secondary hematologic malignancies. The CAR-T REMS program was eliminated in June 2025.
- February 28, 2022 · FDA approval for r/r multiple myeloma after ≥4 prior lines
- April 19, 2024 · Class-wide boxed warning added: secondary T-cell malignancy
- June 26, 2025 · FDA eliminates REMS for approved CAR-T therapies
- October 10, 2025 · Boxed warning added: immune effector cell-associated enterocolitis Latest
The hematology and medical oncologist at Moffitt Cancer Center discussed results from the phase 1b/2 CARTITUDE-1 trial of cita-cel in R/R MM.
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OncLive spoke with Omar Castaneda Puglianini, MD, hematology and medical oncologist, Moffitt Cancer Center, to learn more about findings from the phase 1b/2 CARTITUDE-1 trial (NCT03548207) evaluating ciltacabtagene autoleucel (cilta-cel) in patients with relapsed/refractory multiple myeloma.
Investigators found that the overall response rate (ORR) was 97.9%. With longer follow-up, responses to the CAR T-cell therapy deepened. Castaneda Puglianini noted that the stringent complete response (sCR) rate increased from 67% at a median follow-up of 8 to 9 months, to 80.4% at 18 months.
The median duration of response with the agent was 21.8 months, and the median progression-free survival (PFS) was 22.8 months, Castaneda Puglianini adds. Notably, for patients who achieved a sCR, the median PFS was not reached. Response rates were also comparable across patient subgroups, including those who received previous lines of therapy and extramedullary disease. Overall, the efficacy demonstrated by cilta-cel on this study was impressive, Castaneda Puglianini concludes.















