在复发性多发性骨髓瘤 (IKEMA) 中使用伊萨图西玛,卡菲尔佐米布和德克萨米松:多中心,开放性,随机的第三阶段试验
Philippe Moreau1, Meletios-Athanasios Dimopoulos2, Joseph Mikhael3
1Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.
Lancet (London, England)
|June 7, 2021
概括
在复发多发性骨髓瘤患者中,添加伊萨图西马布与卡菲尔佐米布- 德克萨米显著改善了无进展的存活率. 这种组合疗法是治疗的新标准,为这一患者群体提供了更好的结果.
科学领域:
- 血液学
- 癌症学
- 免疫疗法
背景情况:
- 伊萨图西马布是一种用于复发性或耐火性多发性骨髓瘤的抗CD38单克隆抗体.
- 目前的治疗包括利多米德- 德克萨和卡菲尔佐米布- 德克萨的联合治疗.
研究的目的:
- 为了比较伊萨图西马布加卡尔菲尔佐米布- 德克萨与单独使用卡尔菲尔佐米布- 德克萨的疗效.
- 评估复发多发性骨髓瘤患者的无进展生存期.
主要方法:
- 在16个国家对302名患者进行了第三阶段的开放性随机研究.
- 患者接受的是伊萨图西马布加上卡菲尔佐米布- 德克萨或卡菲尔佐米布- 德克萨.
- 主要终点是没有进展的生存期.
主要成果:
- 对照组的中位数为19. 15个月,对照组的中位数为0. 53个月.
- 治疗后出现的3级或更严重的不良事件发生在77%的伊萨图西马布组和67%的对照组中.
- 在这两组中,致命的治疗不良事件发生在3%的患者中.
结论:
- 在复发性多发性骨髓瘤中,伊萨图西马布与卡菲尔佐米布- 德克萨米松联合可显著改善无进展生存率.
- 这种组合代表了这种患者群体的新标准护理.
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