治疗不耐治疗多发性骨髓瘤 (SIRIUS) 患者的达拉图巴单一治疗:一个开放的,随机的,二期试验
Sagar Lonial1, Brendan M Weiss2, Saad Z Usmani3
1Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA, USA.
Lancet (London, England)
|January 19, 2016
概括
在耐火性多发性骨髓瘤患者中,达拉图单一治疗显示出令人鼓舞的疗效,并显示出良好的安全性. 这种针对CD38的新型抗体为重度预治疗的患者提供了新的希望.
科学领域:
- 血液学
- 癌症学
- 免疫疗法
背景情况:
- 对蛋白酶体抑制剂和免疫调节药物耐药的多发性骨髓瘤患者需要新的治疗选择.
- 针对CD38的单克隆抗体Daratumumab在该患者群体中进行了有效性研究.
研究的目的:
- 在复发性或耐药性多发性骨髓瘤患者中评估达拉图穆巴单一治疗的疗效和安全性.
- 为进一步的临床试验确定达拉图巴的最佳剂量.
主要方法:
- 一个开放的,多中心的2期试验,涉及耐火性多发性骨髓瘤的患者.
- 患者被随机分配给静脉注射达拉图巴剂量为8 mg/ kg或16 mg/ kg.
- 主要终点是整体反应率 (ORR).
主要成果:
- 在接受16毫克/ 公斤达拉图穆马布的106名患者中,ORR为29. 2% (95% CI为20. 8 - 38. 9).
- 反应的中位持续时间为7. 4个月,中位无进展生存期为3. 7个月.
- 达拉图穆巴的耐受性很好,疲劳和贫血是最常见的不良反应;没有因不良事件而停止治疗.
结论:
- 在重度预治疗和耐火性多发性骨髓瘤患者中,达拉图单一治疗显示出令人鼓舞的疗效.
- 这种药物在具有挑战性的患者群体中表现出良好的安全性.
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