文章：

普利替普辛联合地塞米松对比地塞米松单药治疗复发/难治性多发性骨髓瘤的随机III期研究（ADMYRE）：年龄<75岁患者的结果

Randomized Phase III Study (ADMYRE) of Plitidepsin in Combination with Dexamethasone vs. Dexamethasone Alone in Relapsed/Refractory Multiple Myeloma: Results for Patients Aged <75 Years

原文发布日期：29 October 2025

DOI: 10.3390/cancers17213482

类型: Article

开放获取: 是

英文摘要：

Background:The phase III ADMYRE trial evaluated plitidepsin plus dexamethasone (DXM) versus DXM alone in patients with relapsed/refractory multiple myeloma (r/r MM). ADMYRE met its primary endpoint, showing a 35% reduction in the risk of progression or death.Methods:Results from a pre-planned subgroup of patients aged <75 years are shown here. This subgroup includes most of the patients evaluated in the ADMYRE study: 145/171 patients (84.8%) in the plitidepsin + DXM arm and 71/84 (84.5%) patients in the DXM alone arm.Results:Compared to the overall ADMYRE population, a higher reduction was found with plitidepsin plus DXM for the risk of progression or death in the primary endpoint: 47.7% vs. 35.0% (Hazard ratio [HR] = 0.523 vs. HR = 0.6509). Higher reduction in the risk of death was also found (28.9% vs. 20.3%; HR = 0.711 vs. HR = 0.797), with a clinically meaningful 5-month difference in median overall survival (13.0 months vs. 8.1 months;p= 0.0350). The safety profile of plitidepsin plus DXM in patients aged <75 years was similar to that observed in the overall population of patients treated in the ADMYRE study. The most common adverse events (all grades) related to the study treatment in patients < 75 years were fatigue (39.2% of patients), gastrointestinal (nausea, 39.2%; vomiting, 19.6%; diarrhea, 14.7%), and myalgia (14.0%).Conclusions:Larger differences in efficacy outcomes while maintaining a similar safety profile, together with a novel mechanism of action, suggest that this combination can be a valid option for patients with r/r MM aged <75 years.

摘要翻译： 

背景：III期ADMYRE试验评估了plitidepsin联合地塞米松（DXM）与单用地塞米松在复发/难治性多发性骨髓瘤（r/r MM）患者中的疗效。该研究已达到主要终点，显示疾病进展或死亡风险降低35%。 方法：本文展示预设的年龄<75岁亚组患者分析结果。该亚组包含ADMYRE研究中绝大多数患者：plitidepsin+DXM组145/171例（84.8%），单用DXM组71/84例（84.5%）。 结果：与整体ADMYRE人群相比，plitidepsin联合DXM在主要终点上显示出更高的疾病进展或死亡风险降低率：47.7%对比35.0%（风险比[HR]=0.523对比HR=0.6509）。死亡风险降低幅度也更高（28.9%对比20.3%；HR=0.711对比HR=0.797），中位总生存期呈现具有临床意义的5个月差异（13.0个月对比8.1个月；p=0.0350）。年龄<75岁患者中plitidepsin联合DXM的安全性与ADMYRE研究整体人群相似。该年龄段患者中最常见的治疗相关不良事件（所有等级）包括乏力（39.2%）、胃肠道反应（恶心39.2%、呕吐19.6%、腹泻14.7%）及肌痛（14.0%）。 结论：在保持相似安全性的同时获得更显著的疗效差异，结合其独特的作用机制，表明该联合方案可作为年龄<75岁r/r MM患者的有效治疗选择。

原文链接：

Randomized Phase III Study (ADMYRE) of Plitidepsin in Combination with Dexamethasone vs. Dexamethasone Alone in Relapsed/Refractory Multiple Myeloma: Results for Patients Aged <75 Years