联盟A061202:第一个复发的lenalidomide耐药MM患者的ixazomib,pomalidomide和dexamethasone
Peter Voorhees1, Vera Suman2, Yvonne Efebera3
1Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health - Wake Forest School of Medicine, Charlotte, NC.
Blood advances
|July 26, 2024
概括
将伊克萨佐米布添加到波马利多米德和德克萨米中显著改善了莱纳利多米德耐药多发性髓瘤患者在第一次复发时的响应率和无进展生存率.
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:
- 在第一个复发时,针对勒纳利多米德耐药性多发性骨髓瘤的最佳治疗方法尚未确定.
- 对于在莱纳利多米德治疗后进展的患者,需要有效的治疗选择.
研究的目的:
- 为了评估艾克萨佐米布,波马利多米德和德克萨米松 (IXA-POM-DEX) 与波马利多米德和德克萨米松 (POM-DEX) 的疗效和安全性,在患有莱纳利多米德耐药性多发性骨髓瘤的患者中进行首次复发.
主要方法:
- 一个随机的2期研究,比较IXA-POM-DEX (三倍) 与POM-DEX (双倍).
- 关键终点包括整体应答率 (ORR) 和无进展生存率 (PFS).
- 患者是那些在第一次复发时患有勒纳利多米德耐药的多发性骨髓瘤的人.
主要成果:
- 对IXA-POM-DEX的ORR为63.2%,而对POM-DEX的ORR为43.6%.
- 与POM-DEX (7.5个月) 相比,IXA-POM-DEX (20.3个月) 的中位数PFS显著更长.
- 更深层次的反应 (非常好的部分反应或更好) 在三重疗法中更频繁.
结论:
- 完全口服的三重疗法 (伊克萨佐米布,波马利多米德和德克萨梅他) 在响应率和无进展生存期方面表现出更高的疗效.
- 这种组合值得在勒纳利多米德耐火性多发性骨髓瘤的第三阶段研究中进一步调查.
- 虽然血液学毒性增加了,但非血液学不良事件在治疗臂之间是相似的.
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