Clinical outcomes with ciltacabtagene autoleucel among patients with relapsed/refractory multiple myeloma after four or more prior lines of therapy overall and among subgroups based on age, frailty, and CRAB symptoms.

BACKGROUND: Ciltacabtagene autoleucel (cilta-cel), a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy, has shown deep and durable responses in clinical trials for relapsed/refractory multiple myeloma (RRMM). This study aimed to provide a descriptive evaluation of outcomes among patients who received cilta-cel in clinical practice, including among subgroups based on patient characteristics that could impact outcomes. METHODS: This retrospective study used Loopback Analytics electronic medical records (02/2021-06/2025) to identify adults with RRMM who received cilta-cel after ≥4 prior lines of therapy (LOT). The index date was defined as the cilta-cel infusion date. As a surrogate outcome for progression-free survival, treatment-free interval (TFI) was defined as the time from infusion to the earliest of initiation of next treatment or death. Overall survival (OS) was defined as the time from infusion to death. To more accurately identify patients with a next LOT, the date of next treatment was defined as the earliest fill or administration for an eligible agent ≥60 days post-infusion, provided that the patient had ≥2 fills or administrations of the same agent. Kaplan-Meier analyses assessed TFI and OS in all patients and by subgroups defined by age (≥75 years), frailty index score (mild-to-severe frailty) in the three months pre-infusion, and CRAB symptoms (hypercalcemia, renal impairment, anemia, or bone lesions; ≥1 symptom) in the one month pre-infusion. RESULTS: Among 203 patients, 8.4% were aged ≥75 years, 14.8% were mildly-to-severely frail, and 38.4% had ≥1 CRAB symptom. Median (interquartile range) follow-up was 17.6 (12.0-24.2) months. For TFI, the estimated Kaplan-Meier rates (95% confidence interval) at 12 and 18 months post-infusion were 85.5% (79.6%-89.8%) and 76.5% (69.0%-82.4%), respectively, while the OS rates were 95.1% (90.8%-97.4%) and 93.0% (87.8%-96.0%). Across subgroups, TFI remained generally consistent with the overall population and OS remained high. CONCLUSIONS: This study demonstrated favorable outcomes among patients with RRMM who received cilta-cel after ≥4 prior LOT in clinical practice, including among patients with older age, higher frailty index score, and recent presence of CRAB symptoms.