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Long-Term Progression-Free Survival Benefit with Ciltacabtagene Autoleucel in Standard-Risk relapsed/refractory Multiple Myeloma
Abstract   Peer reviewed

Long-Term Progression-Free Survival Benefit with Ciltacabtagene Autoleucel in Standard-Risk relapsed/refractory Multiple Myeloma

Luciano J. Costa, Albert Oriol, Dominik Dytfeld, Salomon Manier, Peter M. Voorhees, Yi Lin, Myo Htut, Wilfried Roeloffzen, Phoebe Joy Ho, Urvi A. Shah, …
Transplantation and cellular therapy, Vol.32(2), pp.S152-S152
02/2026
DOI: 10.1016/j.jtct.2025.12.208

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Abstract

Introduction Ciltacabtagene autoleucel (cilta-cel) showed a significant benefit versus standard of care (SOC) for patients with relapsed/refractory multiple myeloma (RRMM) after 1–3 prior lines of therapy in the CARTITUDE-4 study (NCT04181827). Here, we report outcomes for patients with standard-risk cytogenetics receiving cilta-cel in the intent-to-treat (ITT) and as-treated populations in CARTITUDE-4. Methods Patients randomized to cilta-cel underwent apheresis and bridging therapy with pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone, lymphodepletion therapy, and a single cilta-cel infusion. PFS in the as-treated population was evaluated from cilta-cel infusion. Minimal residual disease (MRD)-negative complete response (CR) at 12 months was defined per International Myeloma Working Group criteria as the proportion of patients achieving CR or better before and at 12 months (±3 months) and MRD negativity (next-generation sequencing [10-5]) at 12 months (+3 months) after cilta-cel infusion, before progressive disease or subsequent anti-myeloma therapy. The ITT population included 208 patients, of whom 32 progressed or died on bridging therapy, leaving 176 patients (85%) in the as-treated population. Patients with high-risk (ie, del[17p], t[14;16], t[4;14], gain/amp[1q]; n=105) or unknown (n=12) cytogenetics, were excluded from the as-treated analysis. Results At a median follow-up of 33.6 months, the 30-month PFS rate (95% confidence interval [CI]) for patients in the ITT population with standard-risk cytogenetics was 71.0% (58.8–80.2) in the cilta-cel arm (n=69) vs 43.2% (31.3–54.5) in the SOC arm (N=70; Table). In the as-treated population, patients with standard-risk cytogenetics (n=59) had a 30-month PFS rate of 80.5% (95% CI, 67.2–88.8); 8 PFS events occurred within 1 year, and 4 events occurred beyond 1 year of cilta-cel infusion. Twenty-six patients achieved MRD-negative CR at 12 months; all were progression free at 30 months. Fourteen patients were not evaluable for MRD (calibration failure [n=12], no testing sample available [n=1], or indeterminate post-baseline results [n=1]). Conclusions The PFS rate at 2.5 years for patients with RRMM and standard-risk cytogenetics observed here was higher than that observed in CARTITUDE-1, supporting the use of cilta-cel as second-line therapy. In the as-treated population in CARTITUDE-4, 80% of patients with standard-risk cytogenetics were progression and treatment free at 2.5 years, which increased to 100% in those who achieved MRD-negative CR at 1 year. The low rate of progression events in cilta-cel–treated patients with standard-risk cytogenetics demonstrates the profound benefit of a single cilta-cel infusion in this population.

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