Results of the CARTITUDE-4 trial assessing patient-reported outcomes in those with multiple myeloma receiving the chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel (cilta-cel) showed improved health-related quality of life and delayed symptom worsening.
The study was led by Roberto Mina, MD, of the Università degli Studi di Torino, and published in The Lancet Haematology.
The ongoing, open-label, phase 3 trial recruited from 81 sites in the United States, Europe, Asia, and Australia and randomized patients 1:1 to receive cilta-cel (0.75 × 106 CAR T cells/kg; n=208) or standard of care (n=211), which consisted of daratumumab, pomalidomide, and dexamethasone or pomalidomide, bortezomib, and dexamethasone. All patients were lenalidomide-refractory and received one to three prior therapies, including a proteasome inhibitor and an immunomodulatory drug.
Most patients (92% cilta-cel and 91% standard of care) completed baseline assessments. According to results from the Multiple Myeloma Symptom and Impact Questionnaire, median time to sustained symptom worsening was 23.7 months with cilta-cel versus 18.9 months with standard of care (hazard ratio, 0.42; 95% CI, 0.26-0.68).
The 12-month mean change in European Organisation for Research and Treatment of Cancer global health status was +10.1 points with cilta-cel (95% CI, 7.0-13.1) and –1.5 points with standard of care (95% CI, –5.3-2.3). The 12-month mean change in EuroQol 5-Dimension 5-Level visual analogue scale was +8.0 points with cilta-cel (95% CI, 5.2-10.7) and +1.4 points with standard of care (95% CI, –1.9-4.7).
“Health-related [quality of life] improvements and delayed symptom worsening support cilta-cel’s clinical efficacy in lenalidomide-refractory disease,” the authors concluded.
The study was funded by Janssen Research & Development and Legend Biotech USA.
Reference
Mina R, Mylin AK, Yokoyama H, et al. Patient-reported outcomes following ciltacabtagene autoleucel or standard of care in patients with lenalidomide-refractory multiple myeloma (CARTITUDE-4): results from a randomised, open-label, phase 3 trial. Lancet Haematol. 2025;12(1):e45-e56. doi:10.1016/S2352-3026(24)00320-X
