Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens
An analysis of secondary outcomes from the KarMMA-3 trial (NCT03651128) have recently been published in the journal Lancet Hematology. Previously, the phase 3 KarMMa-3 trial showed that idecabtagene vicleucel (ide-cel) demonstrated a significant improvement in progression-free survival over standard regimens for adults with relapsed and refractory multiple myeloma who had undergone two to four previous therapies. This analysis, focusing on patient-reported outcomes (PROs) as a secondary endpoint, involved 386 patients randomized to receive either ide-cel or one of several standard regimens.
The evaluation of PROs was based on responses to the European Organisation for Research and Treatment of Cancer Quality of Life C30 Questionnaire, the Multiple Myeloma Module, and the EQ 5 dimensions, including a visual analogue scale, across nine prespecified domains. These included aspects like quality of life, physical and cognitive functioning, fatigue, pain, disease symptoms, side effects of treatment, and overall health status measured through EQ-5D-5L index score and visual analogue scale. The study assessed changes from baseline to month 20 and analyzed time to confirmed improvement or deterioration using a constrained longitudinal data analysis and Cox proportional hazard models, highlighting the patient-centered benefits of ide-cel in this setting.
Between May 6, 2019, and April 8, 2022, patients were enrolled in the study, with a median age of 63 years and a composition largely of White individuals (65%), followed by Black or African American (9%), Hispanic or Latino (5%), Asian (3%), and others (2%). The median follow-up period was 18.6 months, during which patient-reported outcome (PRO) compliance remained above 75%. The analysis revealed that overall changes from baseline significantly favored ide-cel in most domains, with effect sizes ranging from 0.3 to 0.7. Notably, patients treated with ide-cel experienced significant and clinically meaningful improvements in most primary PRO domains. However, improvements in QLQ-MY20 disease symptoms, side effects of treatment, and EQ-5D-5L index score, although present, did not meet the minimally important difference thresholds within the group. Additionally, the ide-cel group saw shorter times to clinically meaningful improvements across several domains, with few exceptions. The findings suggest that ide-cel significantly enhances health-related quality of life (QoL) for patients with relapsed and refractory multiple myeloma compared to standard regimens after previous therapies. This improvement in PROs underscores the value of ide-cel, particularly highlighting the benefits of a single infusion over ongoing treatment with standard regimens for patients who have been exposed to triple-class treatments. The data indicate not just a survival advantage but also a considerable uplift in QoL aspects, making ide-cel a compelling option for this patient group facing limited therapeutic options.
Reference:
Delforge M, Patel K, Eliason L, et al. Health-related quality of life in patients with triple-class exposed relapsed and refractory multiple myeloma treated with idecabtagene vicleucel or standard regimens: patient-reported outcomes from the phase 3, randomised, open-label KarMMa-3 clinical trial [published correction appears in Lancet Haematol. 2024 Mar 12;:]. Lancet Haematol. 2024;11(3):e216-e227.
https://doi.org/10.1016/S2352-3026(24)00005-X