Health related QoL data of KarMMa-3
KarMMa-3 constitutes an open-label, phase 3 randomized clinical trial aimed at investigating the efficacy of a single infusion of the BCMA-targeting CAR-T cell product ide-cel in comparison to conventional standard-of-care drug-based regimens in patients with RRMM. The enrolled patient cohort was characterized by extensive prior treatments, with all participants having been heavily pretreated, and a notable proportion (2 out of 3 patients) demonstrating refractoriness to triple-class therapies.
The primary endpoint of this study was PFS, and the results indicated a statistically and clinically significant prolongation of PFS in patients treated with ide-cel. The main objective of the study is to establish durable responses but without compromising QoL for the patients. Consequently, an important sub-study within the KarMMa-3 trial focused on HRQoL. This investigation employed various standardized scales, including the EORTC QLQ-C30, EORTC QLQ-MY20, and the EuroQol utility index, assessing patients at different intervals over an observation period exceeding two years.
An initial decrease in global health status was observed, attributable to the fact that patients were precluded from receiving any new treatments during the CAR-T manufacturing process. Following the infusion of ide-cel, a prompt and statistically significant improvement in QoL parameters was observed, manifesting not only as statistical significance but also as clinical relevance. Overall health status enhanced, encompassing physical well-being, mental functionality, and mitigation of core side effects such as fatigue and pain. This improvement stood in marked contrast to the control group, wherein QoL either stabilized or exhibited deterioration. Notably, the reported HRQoL enhancement manifested earlier in treated patients than in those undergoing the standard regimen.
In conclusion, the singular administration of ide-cel not only yielded a markedly superior haematological response but also significantly enhanced the overall quality of life for the patients.
Reference:
Delforge M, ASH2023. #96
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