Early daratumumab-based therapy demonstrates significant effectiveness in patients with relapsed and refractory multiple myeloma: a real-world retrospective investigation

This research aimed to assess the effectiveness of daratumumab in the treatment of relapsed and refractory multiple myeloma (RRMM) within a real - world setting. We conducted a retrospective analysis of the clinical features and treatment outcomes of patients diagnosed with RRMM at the Union Hospital of Fujian Medical University from 2018 to 2024. The study cohort consisted of 62 patients, with a median age of 62 years. 80.6% of patients received one line therapy before administration of daratumumab. The median follow - up duration was 16.1 (1.9 - 69.6) months, and the median number of daratumumab treatment cycles was 7.5 (1 - 72) courses. Among the 56 evaluable cases, the overall response rate (ORR) was 89.3%, which included 11 cases (19.6%) attaining a stringent complete response (sCR) and 13 cases (23.2%) achieving a complete response (CR). The median progression free survival (PFS) of the entire cohort was 25.2 months. The 1 - year and 3 - year PFS rates were 75.2% and 25.4% respectively. The median overall survival (OS) was 42.7 months. The 1 - year and 3 - year OS rates were 84.2% and 62.8% respectively. Multivariate analysis indicated that poor performance status was independent unfavorable prognostic factors for PFS and OS. In conclusions, an early daratumumab - based treatment regimen has demonstrated promising therapeutic potential for treating RRMM and warrants further validation and exploration in future clinical practice.

本研究旨在评估真实世界环境中达雷妥尤单抗（daratumumab）治疗复发难治性多发性骨髓瘤（relapsed and refractory multiple myeloma, RRMM）的疗效。我们对2018年至2024年于福建医科大学附属协和医院确诊为RRMM的患者的临床特征与治疗结局开展回顾性分析。本研究队列共纳入62例患者，中位年龄为62岁。其中80.6%的患者在接受达雷妥尤单抗治疗前已接受过一线治疗。中位随访时长为16.1（1.9~69.6）个月，达雷妥尤单抗的中位治疗疗程数为7.5（1~72）个疗程。在56例可评估病例中，总缓解率（overall response rate, ORR）为89.3%，其中11例（19.6%）达到严格意义完全缓解（stringent complete response, sCR），13例（23.2%）达到完全缓解（complete response, CR）。全队列的中位无进展生存期（progression free survival, PFS）为25.2个月，1年和3年PFS率分别为75.2%和25.4%；中位总生存期（overall survival, OS）为42.7个月，1年和3年OS率分别为84.2%和62.8%。多因素分析显示，体力状况不佳是PFS与OS的独立不良预后因素。综上，基于达雷妥尤单抗的早期治疗方案在RRMM治疗中展现出良好的应用潜力，值得在未来临床实践中进一步验证与探索。