在现实世界复发/耐药多发性骨髓瘤患者中,伊萨图西马布加上波马利多米德和德克萨美:回顾性IMAGE研究
Olivier Decaux1,2, Jean Fontan3, Aurore Perrot4
1INSERM, Établissement Français du Sang de Bretagne, Unité Mixte de Recherche (UMR) S1236, Université de Rennes 1, Rennes, France.
European journal of haematology
|May 7, 2024
概括
IMAGE研究发现,伊萨图西马布与波马利多米德和甲 (Isa-Pd) 结合,在复发性/耐药性多发性髓瘤患者中显示出显著的无进展生存率和应答率. 这些真实世界的数据证实了Isa-Pdd的存在.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床研究 临床研究
背景情况:
- 对复发性/耐药性多发性骨髓瘤 (RRMM) 患者进行了回顾性队列研究.
- 在法国早期准入计划 (EAP) 中,患者接受了伊萨图西马布加上波马利多米德和德克萨美 (Isa-Pd).
研究的目的:
- 评估Isa-Pd在RRMM患者中的实际有效性和安全性.
- 在临床实践环境中评估无进展生存率 (PFS) 和反应率.
主要方法:
- 包括294名 (有效性) 和299名 (安全性) 患有RRMM的18岁以上的患者.
- 从2019年7月到2020年8月收集的数据.
- 使用医学监管活动词典 (MedDRA) 编码的不良事件 (AE).
主要成果:
- 中位数的PFS为12.4个月 (95% CI为9.0-15.0).
- 总体响应率 (ORR) 为46.3%;非常好的部分响应率 (VGPR) 为27.9%.
- 26.4%的患者报告任何AE;中性质减退是最常见的 (9.4%).
结论:
- Isa-Pd在RRMM中表现出有意义的现实有效性,与临床试验结果一致.
- 在这个患者群体中,没有发现新的安全问题.
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