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Introduction <p>Ciltacabtagene autoleucel (cilta-cel) was approved in February 2022 for adults with relapsed/refractory multiple myeloma (RRMM). This study evaluated US real-world outcomes among patients with RRMM treated with cilta-cel after ≥ 4 prior lines of therapy (4 + pLOT), overall and stratified by receipt of bridging therapy (BT).</p> Methods <p>Adults with RRMM receiving standard-of-care cilta-cel after 4 + pLOT were identified using claims data from the Komodo Research Database (01/01/2016–06/30/2024). Treatment-free interval (TFI; time between cilta-cel infusion and initiation of next treatment or death) and overall survival (OS) were evaluated using Kaplan–Meier (KM) analyses. Adjusted multivariate Cox regression was used to assess hazard ratios (HR) and 95% confidence intervals (CIs) for TFI/OS by receipt of BT.</p> Results <p>Among 242 patients receiving cilta-cel (mean age 63.4&#xa0;years, 45.5% were female patients, 54.5% were male patients), those with BT (75.2%) had a higher comorbidity burden (mean Quan-Charlson Comorbidity Index 5.3 vs. 4.7) and higher frailty index score (mild-to-severe 49.4% vs. 28.3%) than those without. The median follow-up was 11&#xa0;months. Using KM methods to account for variable follow-up, the estimated TFI at 18&#xa0;months post-infusion was 80.3%, while the KM estimate of OS at 18&#xa0;months post-infusion was 93.4%. Median TFI or OS was not reached. Patients with BT were numerically less likely to have a TFI event (HR 0.76, 95%&#xa0;CI 0.32–1.80) and more likely to remain alive (HR 0.48, 95%&#xa0;CI 0.13–1.70) relative to those without BT.</p> Conclusion <p>Consistent with pivotal trials, cilta-cel was effective in patients with RRMM and 4 + pLOT in US clinical practice. Findings align with previous results supporting BT effectiveness.</p> <p>Graphical abstract available for this article. </p> Graphical Abstract <p></p>

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FREEDOMM: Fifth-Line or Later Real-World Evaluation of Efficacy and Disease Outcomes in Multiple Myeloma with Ciltacabtagene Autoleucel: Treatment-Free Interval and Overall Survival in the USA

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月24日

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  • Sikander Ailawadhi,
  • Doris K. Hansen,
  • Binod Dhakal,
  • Leyla O. Shune,
  • Larry D. Anderson Jr.,
  • Kevin C. De Braganca,
  • Tamar Lengil,
  • Victoria Alegria,
  • Matthew Perciavalle,
  • Jack Hoang Lu,
  • Elizabeth Sacchi,
  • Seina Lee,
  • Bruno Emond,
  • Stephen Huo,
  • Todd Bixby,
  • Zaina P. Qureshi,
  • Douglas W. Sborov

摘要

Introduction

Ciltacabtagene autoleucel (cilta-cel) was approved in February 2022 for adults with relapsed/refractory multiple myeloma (RRMM). This study evaluated US real-world outcomes among patients with RRMM treated with cilta-cel after ≥ 4 prior lines of therapy (4 + pLOT), overall and stratified by receipt of bridging therapy (BT).

Methods

Adults with RRMM receiving standard-of-care cilta-cel after 4 + pLOT were identified using claims data from the Komodo Research Database (01/01/2016–06/30/2024). Treatment-free interval (TFI; time between cilta-cel infusion and initiation of next treatment or death) and overall survival (OS) were evaluated using Kaplan–Meier (KM) analyses. Adjusted multivariate Cox regression was used to assess hazard ratios (HR) and 95% confidence intervals (CIs) for TFI/OS by receipt of BT.

Results

Among 242 patients receiving cilta-cel (mean age 63.4 years, 45.5% were female patients, 54.5% were male patients), those with BT (75.2%) had a higher comorbidity burden (mean Quan-Charlson Comorbidity Index 5.3 vs. 4.7) and higher frailty index score (mild-to-severe 49.4% vs. 28.3%) than those without. The median follow-up was 11 months. Using KM methods to account for variable follow-up, the estimated TFI at 18 months post-infusion was 80.3%, while the KM estimate of OS at 18 months post-infusion was 93.4%. Median TFI or OS was not reached. Patients with BT were numerically less likely to have a TFI event (HR 0.76, 95% CI 0.32–1.80) and more likely to remain alive (HR 0.48, 95% CI 0.13–1.70) relative to those without BT.

Conclusion

Consistent with pivotal trials, cilta-cel was effective in patients with RRMM and 4 + pLOT in US clinical practice. Findings align with previous results supporting BT effectiveness.

Graphical abstract available for this article.

Graphical Abstract