University of California San Francisco, San Francisco, CA, USA.
University Hospital Leuven, Leuven, Belgium.
Leuk Res. 2022 Sep;120:106921. doi: 10.1016/j.leukres.2022.106921. Epub 2022 Jul 21.
To understand the experience of patients with relapsed and refractory multiple myeloma (RRMM) receiving idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor T cell therapy, in the pivotal, phase 2 KarMMa trial.
Optional semi-structured interviews before leukapheresis (pre-treatment) captured expectations and after ide-cel infusion (1, 2, and 3 months post-treatment), assessed treatment experience, ide-cel advantages/disadvantages, and health and well-being. In a mixed-method analysis, treatment experiences were categorized by clinical response status, health and well-being, and self-reported recovery after infusion.
Pre-treatment interviews indicated unmet treatment needs. In post-treatment interviews, most patients reported the positives of ide-cel outweighed negatives (69%, n = 27/39). Most common advantages of ide-cel were efficacy (18-64%), favorable side-effect profile (46-68%), and recovery time (13-18%); most common disadvantages were related to side effects (13-20%). When analyzed by clinical response, patients most often had stringent complete or very good partial response and improved health and well-being with mild or severe recovery from the infusion (27/58, 47%). Most patients with minimal clinical response reported mild infusion recovery (5/6, 83%).
Patient interviews before ide-cel treatment showed unmet needs in triple-class exposed RRMM. Post-treatment experiences generally favored ide-cel versus previously received treatments.
了解复发/难治性多发性骨髓瘤(RRMM)患者接受 idecabtagene vicleucel(ide-cel)治疗的体验,ide-cel 是一种 B 细胞成熟抗原导向的嵌合抗原受体 T 细胞疗法,该研究来自关键性、2 期 KarMMa 试验。
在白细胞分离(预处理)前进行可选的半结构化访谈,以了解治疗前的预期,在 ide-cel 输注后(治疗后 1、2 和 3 个月)进行访谈,评估治疗体验、ide-cel 的优缺点以及健康和幸福感。采用混合方法分析,根据临床反应状态、健康和幸福感以及输注后自我报告的恢复情况对治疗体验进行分类。
预处理访谈表明存在未满足的治疗需求。在治疗后访谈中,大多数患者报告 ide-cel 的积极影响超过消极影响(69%,39/57)。ide-cel 的最常见优点是疗效(18-64%)、有利的副作用谱(46-68%)和恢复时间(13-18%);最常见的缺点与副作用有关(13-20%)。根据临床反应进行分析时,患者通常具有严格的完全缓解或非常好的部分缓解,并且健康和幸福感得到改善,输注后的恢复从轻到重(27/58,47%)。少数患者的临床反应最小,报告输注后恢复较轻(5/6,83%)。
ide-cel 治疗前的患者访谈显示,三重暴露的 RRMM 存在未满足的需求。治疗后体验通常有利于 ide-cel 治疗,而不是之前接受的治疗。