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Introduction <p>Ciltacabtagene autoleucel (cilta-cel) has demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma (RRMM), supporting the goal of sustained minimal residual disease (MRD) negativity as a marker for potential functional cure, characterized by prolonged treatment-free disease control. Initially, cilta-cel was approved in the US for RRMM after ≥ 4 prior lines of therapy (LOT), and after 1–3 prior LOT in April 2024. This study describes real-world clinical outcomes, including MRD negativity, of cilta-cel after 1–3 prior LOT.</p> Methods <p>Electronic medical records from Loopback Analytics (April 2024–May 2025) were used, supplemented with physician notes. Adults with RRMM treated with cilta-cel after 1–3 prior LOT were included. Post-infusion outcomes (cilta-cel response, MRD negativity, disease progression, and overall survival) were assessed overall and by bridging therapy (BT) regimen.</p> Results <p>Overall, 120 patients were included (median age 67&#xa0;years, 43.3% female). Prior to infusion, 87.5% received BT, including alkylator-based (28.6%), IMiD ± mAb-based (25.7%), PI-based (20.0%), talquetamab (14.3%), and other regimens (11.4%). Over a median follow-up of 5.8&#xa0;months, among patients with a response assessment (81.7%), the overall response rate (ORR) to cilta-cel was 98.0%, including 72.4% with complete response. Among 36 MRD-evaluable patients, MRD negativity (10<sup>–5</sup>) was achieved in 35 (97.2%), with a median time to MRD negativity of 80.0&#xa0;days. At last follow-up, 94.2% of patients remained progression-free, 95.8% had not initiated subsequent treatment, and 99.2% remained alive. Across BT regimens, ORR to cilta-cel was 95–100% and MRD negativity was achieved in 80–100%.</p> Conclusions <p>This real-world study demonstrates the effectiveness of cilta-cel in RRMM after 1–3 prior LOT. High rates of response and MRD negativity were reported overall and across BT regimens, including talquetamab. Longer follow-up with repeated MRD measurements may provide further insights into response durability and survival outcomes, helping to contextualize the potential for a functional cure.</p> Graphical Abstract <p></p>

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IMMPACT-MM: Insights into Multiple Myeloma Patient Outcomes following Early-Line Cilta-cel Treatment

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年6月28日

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  • Sridevi Rajeeve,
  • Saurabh P. Nagar,
  • Sabyasachi Ghosh,
  • Victoria Alegria,
  • Justin Hayne,
  • Bruno Emond,
  • Jessica Maitland,
  • Zaina P. Qureshi,
  • Larry D. Anderson Jr.

摘要

Introduction

Ciltacabtagene autoleucel (cilta-cel) has demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma (RRMM), supporting the goal of sustained minimal residual disease (MRD) negativity as a marker for potential functional cure, characterized by prolonged treatment-free disease control. Initially, cilta-cel was approved in the US for RRMM after ≥ 4 prior lines of therapy (LOT), and after 1–3 prior LOT in April 2024. This study describes real-world clinical outcomes, including MRD negativity, of cilta-cel after 1–3 prior LOT.

Methods

Electronic medical records from Loopback Analytics (April 2024–May 2025) were used, supplemented with physician notes. Adults with RRMM treated with cilta-cel after 1–3 prior LOT were included. Post-infusion outcomes (cilta-cel response, MRD negativity, disease progression, and overall survival) were assessed overall and by bridging therapy (BT) regimen.

Results

Overall, 120 patients were included (median age 67 years, 43.3% female). Prior to infusion, 87.5% received BT, including alkylator-based (28.6%), IMiD ± mAb-based (25.7%), PI-based (20.0%), talquetamab (14.3%), and other regimens (11.4%). Over a median follow-up of 5.8 months, among patients with a response assessment (81.7%), the overall response rate (ORR) to cilta-cel was 98.0%, including 72.4% with complete response. Among 36 MRD-evaluable patients, MRD negativity (10–5) was achieved in 35 (97.2%), with a median time to MRD negativity of 80.0 days. At last follow-up, 94.2% of patients remained progression-free, 95.8% had not initiated subsequent treatment, and 99.2% remained alive. Across BT regimens, ORR to cilta-cel was 95–100% and MRD negativity was achieved in 80–100%.

Conclusions

This real-world study demonstrates the effectiveness of cilta-cel in RRMM after 1–3 prior LOT. High rates of response and MRD negativity were reported overall and across BT regimens, including talquetamab. Longer follow-up with repeated MRD measurements may provide further insights into response durability and survival outcomes, helping to contextualize the potential for a functional cure.

Graphical Abstract