Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma
Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma
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DOI：
10.1056/nejmoa1607751
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发表时间：
2016-10-06
影响因子：
158.5
通讯作者：
Moreau, P.
中科院分区：
文献类型：
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作者：
Dimopoulos, M. A.;Oriol, A.;Moreau, P.
背景在一项涉及复发性或难治性多发性骨髓瘤患者的1-2期研究中，达雷妥尤单抗单独使用以及与来那度胺和地塞米松联合使用显示出良好的疗效。方法在这项3期试验中，我们随机分配了569名曾接受过一种或多种既往治疗的多发性骨髓瘤患者单独接受来那度胺和地塞米松（对照组）或与达雷妥尤单抗联合使用（达雷妥尤单抗组）。在方案规定的中期分析中，在13.5个月的中位随访中，观察到169起疾病进展或死亡事件（达雷妥尤单抗组286例患者中的53例[18.5%]对对照组283例患者中的116例[41.0%];风险比0.37; 95%置信区间[CI]，0.27至0.52; P
BACKGROUNDDaratumumab showed promising efficacy alone and with lenalidomide and dexamethasone in a phase 1-2 study involving patients with relapsed or refractory multiple myeloma.METHODSIn this phase 3 trial, we randomly assigned 569 patients with multiple myeloma who had received one or more previous lines of therapy to receive lenalidomide and dexamethasone either alone (control group) or in combination with daratumumab (daratumumab group). The primary end point was progression-free survival.RESULTSAt a median follow-up of 13.5 months in a protocol-specified interim analysis, 169 events of disease progression or death were observed (in 53 of 286 patients [18.5%] in the daratumumab group vs. 116 of 283 [41.0%] in the control group; hazard ratio, 0.37; 95% confidence interval [CI], 0.27 to 0.52; P