伊克萨佐米布加达拉图穆马布和德克萨米松:在复发/耐药多发性髓瘤患者中进行的第二阶段研究的最终分析
Sosana Delimpasi1, Meletios A Dimopoulos2, Jan Straub3
1Department of Hematology and Bone Marrow Transplantation Unit, General Hospital Evangelismos, Athens, Greece.
American journal of hematology
|June 10, 2024
概括
伊克萨索米布与达拉图穆马布和德克萨米 (IDd) 结合使用,在复发性/耐药性多发性骨髓瘤 (RRMM) 患者中显示出30.5%的整体应答率. 这种新疗法显示出积极的风险-益处概况,中位数无进展生存期为16.8个月.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 多发性骨髓瘤 (MM) 治疗改善了结果,但大多数患者最终会复发,因此需要针对复发性/耐药性MM (RRMM) 进行有效的治疗.
- 由于疾病的异质性和先前的治疗暴露,RRMM的治疗决定是复杂的.
研究的目的:
- 为了评估艾克萨佐米布,达拉图穆马布和德克萨米松 (IDd) 在RRMM患者的疗效和安全性.
- 确定整体响应率 (ORR) 和确认非常好的部分响应率 (VGPR) 作为主要终点.
主要方法:
- 一个单臂,第二阶段临床试验 (NCT03439293) 涉及61名RRMM患者,这些患者以前没有接受过ixazomib和daratumumab.
- 患者在28天的循环中服用口服伊克萨佐米布与达拉图穆马布和甲 (IDd) 结合,直到疾病进展或不可接受的毒性.
- 数据分析包括应答率,无进展生存期 (PFS) 和治疗出现的不良事件 (TEAE).
主要成果:
- 在59名响应可评估患者中,确定的VGPR率 (主要终点) 为30.5%,ORR为64.4%.
- 无进展生存时间的中位数为16.8个月 (95% CI:10.1-23.7),平均随访时间为31.6个月.
- 3级以上的TEAE发生在54.1%的患者中;外围神经病变 (任何级别) 发生在18.0%的患者中,1.6%级别≥3.6%. 生活质量通常保持不变.
结论:
- 在RRMM患者中,IDd疗法表现出显著的活性和可管理的安全性.
- IDd在临床相关的小组中显示出有效性,包括那些具有高风险细胞遗传和lenalidomide耐药性疾病的小组.
- 该研究支持IDd作为RRMM的可行治疗选择,具有积极的风险益处概况,并且没有发现新的安全信号.
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