Teclistamab Improves Patient-Reported Symptoms and Health-Related Quality of Life in Relapsed or Refractory Multiple Myeloma: Results From the Phase II MajesTEC-1 Study

医学 生活质量(医疗保健) 物理疗法 析因分析 耐火材料(行星科学) 健康相关生活质量 临床试验 内科学 最小临床重要差异 多发性骨髓瘤 疾病 随机对照试验 物理 护理部 天体生物学
作者
Thomas G. Martin,Philippe Moreau,Saad Z. Usmani,Alfred L. Garfall,María‐Victoria Mateos,Jesús F. San Miguel,Albert Oriol,Ajay K. Nooka,Laura Rosiñol,Ajai Chari,Lionel Karlin,Amrita Krishnan,Nizar J. Bahlis,Rakesh Popat,Britta Besemer,Joaquín Martínez‐López,Michel Delforge,Danielle Trancucci,Lixia Pei,Rachel Kobos
出处
期刊:Clinical Lymphoma, Myeloma & Leukemia [Elsevier BV]
卷期号:24 (3): 194-202 被引量:7
标识
DOI:10.1016/j.clml.2023.11.001
摘要

Introduction 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. Patients and Methods In the phase 1/2 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 Five Dimension Five 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. Results 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. Conclusions These results complement previously reported clinical benefits and support teclistamab as a promising therapeutic option for patients with RRMM.
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