Autologous Transplantation and Maintenance Therapy in Multiple Myeloma
Autologous Transplantation and Maintenance Therapy in Multiple Myeloma
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DOI：
10.1056/nejmoa1402888
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发表时间：
2014-09-04
影响因子：
158.5
通讯作者：
Cavo, M.
中科院分区：
文献类型：
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作者：
Palumbo, A.;Cavallo, F.;Cavo, M.
这项开放标签，随机，一项3期研究在新诊断的多发性骨髓瘤患者中比较了美法仑200 mg/m2体表面积加自体干细胞移植与美法仑-泼尼松-来那度胺（MPR），并比较了来那度胺维持治疗与不维持治疗。诱导后行细胞移植或MPR巩固治疗，251例患者行来那度胺维持治疗或不进行维持治疗。主要终点是无进展生存期，中位随访期为51.2个月。大剂量美法仑联合干细胞移植组的无进展生存期和总生存期均显著长于MPR组（中位无进展生存期，43.0个月对22.4个月;进展或死亡的风险比，0.44; 95%可信区间[CI]，0.32 - 0.61; P
BACKGROUNDThis open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma.METHODSWe randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction, and 251 patients to lenalidomide maintenance therapy or no maintenance therapy. The primary end point was progression-free survival.RESULTSThe median follow-up period was 51.2 months. Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR (median progression-free survival, 43.0 months vs. 22.4 months; hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.32 to 0.61; P