易布鲁替尼与莱纳利多米德 (Revlimid/Dexamethasone) 结合使用,治疗复发性/逆转性多发性骨髓瘤 (AFT-15)
Yvonne Efebera1, Vera Suman2, Shira Dinner3
1MPH, OhioHealth, Columbus, OH 43214, USA, yvonne.efebera@ohiohealth.com.
Cancers
|August 14, 2025
概括
这一第一阶段试验发现,在复发性/耐药性多发性髓瘤 (MM) 中,将利那利多米德 (LEN) 与易布鲁替尼 (IBR) 和德甲 (DEX) 结合使用是可行的. 该疗法显示出可管理的毒性,疾病进展是停止治疗的主要原因.
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:
- 列纳利多米德 (LEN) 和易布鲁替尼 (IBR) 在多发性骨髓瘤 (MM) 中显示出潜在的协同效应.
- 这两种药物都向IRF4,这是髓瘤细胞存活的关键调节者.
研究的目的:
- 为了确定与莱纳利多米德 (LEN) 和甲 (DEX) 结合使用的易布鲁替尼 (IBR) 的最大耐受剂量 (MTD).
- 评估这种组合在复发/耐药多发性骨髓瘤 (RR MM) 患者的安全性和有效性.
主要方法:
- 采用了3+3第一阶段试验设计.
- 患者接受了口服IBR,LEN和DEX,剂量逐渐增加.
- 对剂量限制性毒性 (DLT) 进行了监测,以确定MTD.
- 评估了整体反应率 (ORR) 和临床益处率 (CBR).
主要成果:
- 该研究招募了14名患者;13人被纳入分析.
- 只有一个患者出现了剂量限制性毒性 (3级非病毒性肝炎).
- 整体响应率 (ORR) 为15.4%,其中有一个完全响应 (CR) 和一个非常好的部分响应 (VGPR).
- 包括稳定疾病 (SD) 在内的临床益处率 (CBR) 为61.5%.
结论:
- 在RR MM中,LEN和IBR与DEX的组合是可行的.
- 该疗法证明了可管理的毒性.
- 疾病进展是停止治疗的主要原因.
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