Abstract：
Patients with relapsed or refractory multiple myeloma (RRMM) report significantly lower HRQoL compared with patients with newly diagnosed MM and experience further deterioration in HRQoL with each relapse and subsequent treatment. Therefore, consideration of the impact of treatment on HRQoL in addition to clinical outcomes is vital.
In the phase I/II MajesTEC-1 (NCT03145181, NCT04557098) study, patients with RRMM who received teclistamab, an off-the-shelf, T-cell redirecting BCMA × CD3 bispecific antibody, had deep and durable responses with manageable safety. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30-item and the EuroQol 5 Dimension 5 Level descriptive questionnaire. Changes over time from baseline were measured with a repeated measures mixed-effects model. Proportions of patients with clinically meaningful improvement after starting treatment and time to clinically meaningful worsening were assessed.
Compliance was maintained throughout the study. Compared with baseline, positive changes were observed for pain, global health status, and emotional functioning with treatment; other assessments were largely unchanged from baseline. Post hoc analysis showed patients with deeper clinical response generally reported improved HRQoL outcomes. Following an initial decline in HRQoL in some scales, the proportion of patients reporting clinically meaningful improvements increased, while the proportion reporting clinically meaningful worsening decreased over time. Clinically meaningful improvements in pain were reported in ≥40% of patients at most assessment time points.
These results complement previously reported clinical benefits and support teclistamab as a promising therapeutic option for patients with RRMM.
In the phase I/II MajesTEC-1 (NCT03145181, NCT04557098) study, patients with RRMM who received teclistamab, an off-the-shelf, T-cell redirecting BCMA × CD3 bispecific antibody, had deep and durable responses with manageable safety. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30-item and the EuroQol 5 Dimension 5 Level descriptive questionnaire. Changes over time from baseline were measured with a repeated measures mixed-effects model. Proportions of patients with clinically meaningful improvement after starting treatment and time to clinically meaningful worsening were assessed.
Compliance was maintained throughout the study. Compared with baseline, positive changes were observed for pain, global health status, and emotional functioning with treatment; other assessments were largely unchanged from baseline. Post hoc analysis showed patients with deeper clinical response generally reported improved HRQoL outcomes. Following an initial decline in HRQoL in some scales, the proportion of patients reporting clinically meaningful improvements increased, while the proportion reporting clinically meaningful worsening decreased over time. Clinically meaningful improvements in pain were reported in ≥40% of patients at most assessment time points.
These results complement previously reported clinical benefits and support teclistamab as a promising therapeutic option for patients with RRMM.
摘要：
背景：与新诊断的MM患者相比，复发或难治性多发性骨髓瘤（RRMM）患者的HRQoL显着降低，并且随着每次复发和后续治疗，HRQoL进一步恶化。因此,除临床结局外,考虑治疗对HRQoL的影响至关重要.
方法：在I/IIMajesTEC-1（NCT03145181，NCT04557098）研究中，接受泰利他单抗治疗的RRMM患者，一个现成的，T细胞重定向BCMA×CD3双特异性抗体，有深刻而持久的反应，安全可控。HRQoL使用欧洲癌症研究与治疗组织生活质量问卷核心30项和EuroQol5维度5级描述性问卷进行评估。使用重复测量混合效应模型测量相对于基线随时间的变化。评估了开始治疗后具有临床意义的改善的患者比例以及达到临床意义恶化的时间。
结果：在整个研究过程中保持依从性。与基线相比，观察到疼痛的积极变化，全球健康状况,和治疗后的情绪功能;其他评估与基线相比基本没有变化.事后分析显示，临床反应较深的患者通常报告HRQoL结果改善。在HRQoL在某些尺度上最初下降之后，报告有临床意义的改善的患者比例增加，而报告有临床意义的恶化的比例随着时间的推移而下降。在大多数评估时间点，≥40％的患者报告了有临床意义的疼痛改善。
结论：这些结果补充了先前报道的临床益处，并支持替列他单抗作为RRMM患者的一种有希望的治疗选择。
方法：在I/IIMajesTEC-1（NCT03145181，NCT04557098）研究中，接受泰利他单抗治疗的RRMM患者，一个现成的，T细胞重定向BCMA×CD3双特异性抗体，有深刻而持久的反应，安全可控。HRQoL使用欧洲癌症研究与治疗组织生活质量问卷核心30项和EuroQol5维度5级描述性问卷进行评估。使用重复测量混合效应模型测量相对于基线随时间的变化。评估了开始治疗后具有临床意义的改善的患者比例以及达到临床意义恶化的时间。
结果：在整个研究过程中保持依从性。与基线相比，观察到疼痛的积极变化，全球健康状况,和治疗后的情绪功能;其他评估与基线相比基本没有变化.事后分析显示，临床反应较深的患者通常报告HRQoL结果改善。在HRQoL在某些尺度上最初下降之后，报告有临床意义的改善的患者比例增加，而报告有临床意义的恶化的比例随着时间的推移而下降。在大多数评估时间点，≥40％的患者报告了有临床意义的疼痛改善。
结论：这些结果补充了先前报道的临床益处，并支持替列他单抗作为RRMM患者的一种有希望的治疗选择。
