印度患有复发性和耐火性多发性骨髓瘤的患者的达拉图巴:一个前性的,多中心的第四期研究
Lalit Kumar1, Sameer Melinkeri2, Prasanth Ganesan3
1Department of Medical Oncology, All India Institute of Medical Sciences, New Delhi, 110608, India.
Future oncology (London, England)
|December 20, 2023
概括
达拉图穆马布单疗法在印度患者中表现出可接受的安全性和一致的疗效,这些患者患有复发性/耐药性多发性髓瘤. 这项研究为这种患者群体提供了新的治疗选择.
科学领域:
- 血液学 血液学 血液学
- 临床瘤学临床瘤学
- 药理学 药理学是指药理学的学科.
背景情况:
- 多发性骨髓瘤是一种血液性恶性瘤,对于复发/耐药病例的治疗选择有限.
- 达拉图马布是一种单克隆抗体,向CD38,并且在多发性骨髓瘤治疗中表现有前途.
- 关于达拉图穆马布在印度人口中的安全性和有效性的真实数据至关重要.
研究的目的:
- 评估达拉图穆马布单一疗法的安全性和有效性,用于印度患有复发性/耐药性多发性髓瘤的患者.
- 评估治疗出现的不良事件和整体反应率.
- 确定对无进展生存率和患者福祉的影响.
主要方法:
- 一个前性的,多中心的,第四期临床研究.
- 139名年龄在18岁或以上,患有复发性/耐药性多发性骨髓瘤的印度患者被纳入研究.
- 患者在六个周期内接受静脉注射达拉图穆马布 (16毫克/千克),安全性是主要终点.
主要成果:
- 87.1%的患者经历了治疗出现的不良事件 (TEAE),其中38.1%被认为与药物相关.
- 23%的人有严重的TEAE,0.7%的死亡与药物有关.
- 总体应答率为26.3%,其中62.7%的病情稳定;中位数无进展生存时间为5.9个月.
结论:
- 达拉图穆马布单一治疗在印度患有复发性/耐药性多发性髓瘤的患者中表现出可接受和可预测的安全性.
- 观察到一致的疗效,功能状态和幸福感的改善.
- 达拉图穆马布代表了一种新且有价值的治疗选择,用于在印度管理这种患者群体.
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