目的·探讨剂量减低的来那度胺/美法仑/醋酸泼尼松（lenalidomide/melphalan/prednisone acetate，RMP）全口服方案在老年虚弱新诊断多发性骨髓瘤（newly diagnosed multiple myeloma，NDMM）患者中的疗效和安全性。方法·回顾性纳入2018年4月—2024年3月在上海交通大学医学院附属瑞金医院及昆山市第三人民医院血液科就诊的老年虚弱NDMM患者，收集临床资料及实验室检查指标，采用RMP方案治疗。运用SPSS 27.0和R软件，对正态分布定量资料用独立样本t检验、非正态分布定量资料用Mann-Whitney U检验、定性资料用χ²检验及Fisher确切概率法进行统计学分析，生存分析采用Kaplan-Meier生存曲线法及Log-rank检验。结果·22例接受RMP治疗的老年虚弱NDMM患者，中位年龄76.3（68.4，95.0）岁，中位随访25.5个月。总反应率（overall response rate，ORR）为68.2%，≥非常好的部分缓解（very good partial response，VGPR）率为36.4%。中位无进展生存期（progression-free survival，PFS）为20.53个月，其中≤75岁组中位PFS为25.23（95%CI 12.95~37.52）个月，>75岁组为18.23（95%CI 14.86~21.61）个月，2组比较差异无统计学意义。≥部分缓解（partial response，PR）组中位PFS为20.67（95%CI 13.57~27.76）个月，<PR组为8.53（95%CI 6.48~10.59）个月，差异具有统计学意义（P=0.011）。中位疗程数为11（2，24）个。所有级别的血液学治疗相关不良事件（treatment-related adverse events，TRAE）发生率为63.6%，≥3级发生率为18.2%。最常见血液学TRAE是粒细胞减少（63.6%），其中≥3级占13.6%。常见非血液学TRAE为乏力（22.7%）、呼吸道感染（18.2%）、皮疹（18.2%）、胃肠道反应（18.2%）、血栓（13.6%）。6例（27.3%）患者因严重的TRAE导致减量或暂停治疗。结论·剂量减低的全口服RMP方案治疗老年虚弱NDMM患者安全有效，值得临床应用。

Objective ·To investigate the efficacy and safety of a dose-reduced, all-oral lenalidomide/melphalan/prednisone acetate (RMP) regimen in elderly and frail patients with newly diagnosed multiple myeloma (NDMM). Methods ·Elderly and frail NDMM patients who visited the Department of Hematology of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and the Third People's Hospital of Kunshan from April 2018 to March 2024 were retrospectively included. Clinical data and laboratory indicators were collected, and all patients were treated with the RMP regimen. SPSS 27.0 and R software were used for statistical analysis. Independent t-test was applied to normally distributed quantitative data, Mann-Whitney U test to non-normally distributed quantitative data, and χ² test and Fisher's exact probability method to qualitative data. Kaplan-Meier survival curves and Log-rank test were used for survival analysis. Results ·Among the 22 elderly and frail NDMM patients treated with RMP, the median age was 76.3 (68.4, 95.0) years, and the median follow-up time was 25.5 months. The overall response rate (ORR) was 68.2%, and the rate of ≥ very good partial response (VGPR) was 36.4%. The median progression-free survival (PFS) was 20.53 months. The median PFS in the ≤75-year-old group was 25.23 (95%CI 12.95‒37.52) months, while in the >75-year-old group it was 18.23 (95%CI 14.86‒21.61) months. There was no significant difference between the two groups. The median PFS in the ≥ partial response (PR) group was 20.67 (95%CI 13.57‒27.76) months, and in the < PR group it was 8.53 (95%CI 6.48‒10.59) months, with a statistically significant difference (P=0.011). The median number of treatment courses was 11 (2, 24). The incidence of treatment-related hematological adverse events of all grades was 63.6%, and ≥ grade 3 hematological adverse events occurred in 18.2% of patients. The most common treatment-related adverse event (TRAE) in hematology was neutropenia (63.6%), of which ≥ grade 3 neutropenia accounted for 13.6%. Common non-hematological TRAEs included fatigue (22.7%), respiratory tract infections (18.2%), rash (18.2%), gastrointestinal reactions (18.2%), and thrombosis (13.6%). Six patients (27.3%) required dose reduction or treatment suspension due to severe TRAEs. Conclusion ·The dose-reduced, all-oral RMP regimen is safe and effective in treating elderly and frail NDMM patients and is worthy of clinical application.