Health-related quality of life improved in patients with relapsed or refractory multiple myeloma (MM) following treatment with ciltacabtagene autoleucel, according to an analysis of the CARTITUDE-1 trial.
The results were published in the Lancet Haematology by Thomas Martin, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, and colleagues.
The improvement in health-related quality of life was a secondary outcome evaluated using patient-reported outcomes in the CARTITUDE-1 trial, a single-arm, open-label, phase Ib/II study done at 16 centers in the United States.
Patients were aged 18 years or older with diagnosis of MM and an Eastern Cooperative Oncology Group performance status score of one or less with three or more previous lines of therapy or were double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) and had received a PI, IMiD, and anti-CD38 antibody. Patients were treated with a single infusion of ciltacabtagene autoleucel (target dose, 0.75 x 10⁶ CAR+ T cells/kg) administered five to seven days after lymphodepletion.
Of the 78 enrolled patients who underwent apheresis in phase II of the study, 68 were treated, and their patient-reported outcomes were assessed (median follow-up, 16.9 months). After infusion, a transient decline was observed, followed by improvements in global health status (mean change from baseline to day 464, +8.0 points), as well as physical (+4.6 points) and emotional functional scales (+1.9 points) over time and declines for symptom-based scores (–14.1 pain and –15.4 fatigue), indicating improvement in health-related quality of life.
“These durable [health-related quality of life] improvements are consistent with clinical findings, in which a single [ciltacabtagene autoleucel] infusion led to substantial and durable responses in heavily pre-treated patients with relapsed or refractory [MM],” Dr. Martin and colleagues wrote. “These results support the use of [ciltacabtagene autoleucel] in patients with relapsed or refractory [MM].”
Funded by Janssen Research and Development and Legend Biotech USA.
Martin T, Lin Y, Agha M, et al. Health-related quality of life in patients given ciltacabtagene autoleucel for relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b-2, open-label study. Lancet Haematol. 2022;S2352-3026(22)00284-8. doi:10.1016/S2352-3026(22)00284-8