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贝兰他马布 (Belantamab mafodotin),卡菲尔佐米布 (carfilzomib),莱纳利多米德 (lenalidomide) 和德克萨米他 (dexamethasone) 用于复发性或耐火性多发性髓瘤的治疗
Shebli Atrash1, James Symanowski2, Myra Robinson3
1Advocate Health, Charlotte, North Carolina, United States.
Blood advances
|February 20, 2026
概括
与KRd化疗相结合的Belantamab mafodotin在复发性/耐药性多发性髓瘤中显示出高响应率. 贝兰他马布 (Belantamab mafodotin) 的延长剂量间隔是安全有效的,眼部毒性可控.
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:
- 贝兰他马布 (Belantamab mafodotin,belamaf) 是一种针对B细胞成熟抗原的抗体-药物结合物,在复发性/耐药性多发性骨髓瘤 (RRMM) 中有效.
- 眼部毒性是贝拉玛夫已知的副作用,需要仔细评估组合疗法的安全性.
研究的目的:
- 在RRMM患者中,评估每8周一次与卡菲尔佐米布,莱纳利多米德和甲 (KRd-b) 结合使用的贝兰塔马布 (Belantamab mafodotin) 的安全性和初步疗效.
- 为了确定KRd-b组合治疗方案中贝拉玛夫的推第二阶段剂量 (RP2D).
主要方法:
- 阶段1/2研究采用3+3剂量升级设计,以确定belamaf的RP2D (1.4或1.9毫克/公斤每8周).
- 在RP2D中,至少接受过一次先前治疗的19名RRMM患者接受了KRd-b组合治疗.
- 通过不良事件来评估安全性,通过整体响应率 (ORR),非常好的部分响应 (VGPR) 或更好,以及最小残留疾病 (MRD) 的消极性来评估有效性.
主要成果:
- 贝拉玛夫的RP2D被确定为每8周1.9mg/kg,没有观察到剂量限制性毒性.
- 该ORR为89.5%,其中78.9%达到VGPR或更好. 所有完整的响应者都获得了MRD负面.
- 随访时间中位数为19.3个月,24个月无进展生存率 (PFS) 和整体生存率 (OS) 分别为74.3%和85.1%.
- 在94.7%的患者中发生了角膜病变,大多是1-2级,可逆,可控. 在31.6%的患者中,发生了≥3级角质炎.
结论:
- 与KRd结合的延长间隔贝兰他马布 (belantamab mafodotin) 在RRMM患者中显示出深度和持久的反应.
- 延长间隔的KRd-b疗法是可行的,并与可管理的毒性相关,包括眼部事件.
- 这些发现支持在RRMM的第二阶段试验中进一步调查这种组合.
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