CARTITUDE-4 Trial: Cilta-Cel Improves Quality of Life, Delays Symptom Worsening in MM

A study published in The Lancet Haematology outlined patient-reported outcomes of the CARTITUDE-4 trial of ciltacabtagene autoleucel (cilta-cel) versus standard of care in lenalidomide-refractory multiple myeloma (MM).

Investigators of the randomized, open-label, phase III trial previously reported that cilta-cel significantly improved progression-free survival (PFS) compared with standard of care.

A total of 419 patients from 81 sites in the United States, Europe, Asia, and Australia were randomly assigned 1:1 to receive either cilta-cel at a target dose of 0.75 × 10⁶ chimeric antigen receptor T cells/kg (n=208) or standard-of-care therapy (daratumumab, pomalidomide, and dexamethasone or pomalidomide, bortezomib, and dexamethasone; n= 211). Patients had one to three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, and an Eastern Cooperative Oncology Group performance status of 0 or 1. The median follow-up was 15.9 months.

The primary endpoint was PFS. Secondary endpoints included time to sustained worsening of symptoms as reported through the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) and change in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core C30 and EuroQol 5-Dimension 5-Level (EQ-5D-5L).

Baseline assessments were completed by 191 of 208 patients (92%) in the cilta-cel group and 190 of 209 evaluable patients (91%) in the standard- of-care group. After baseline, the MySIm-Q compliance was 70% to 81% for cilta-cel and 79% to 89% for standard of care. The median time to sustained worsening of symptoms, as reported through MySIm-Q, was 23.7 months with cilta-cel and 18.9 months with standard of care (hazard ratio, 0.42; 95% CI, 0.26-0.68).

The average change in EORTC global health status from baseline to 12 months was +10.1 points (95% CI, 7.0-13.1) for cilta-cel and –1.5 points (95% CI, –5.3 to 2.3) for standard of care. The average change in EQ-5D-5L visual analogue scale (VAS) from baseline to 12 months was +8.0 points (95% CI, 5.2-10.7) for cilta-cel and +1.4 points (95% CI, –1.9 to 4.7) for standard of care.

“Rates of clinically meaningful improvements in GHS and VAS were higher with cilta-cel than with standard of care,” the researchers wrote. “Health-related QoL improvements and delayed symptom worsening support cilta-cel’s clinical efficacy in lenalidomide-refractory disease.”

This research was funded by Janssen Research & Development, 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