Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma
Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma
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DOI：
10.1056/nejmoa070594
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发表时间：
2007-11-22
影响因子：
158.5
通讯作者：
Knight, Robert D.
中科院分区：
文献类型：
--
作者：
Dimopoulos, Meletios;Spencer, Andrew;Knight, Robert D.
来那度胺是沙利度胺的结构类似物，具有相似但更强的生物活性。这3期，安慰剂对照试验研究的疗效来那度胺加地塞米松在治疗复发性或难治性多发性myeloma.Methods的351例患者谁收到了至少一个以前的抗骨髓瘤治疗，176人被随机分配到接受25毫克的口服来那度胺和175接受安慰剂的第1天至21天的28天周期。此外，所有患者在前4个周期的第1 - 4、9 - 12和17 - 20天接受40 mg口服地塞米松，随后在第4个周期后仅在第1 - 4天接受。患者继续参与研究，直至发生疾病进展或不可接受的毒性作用。结果来那度胺联合地塞米松组（来那度胺组）的疾病进展时间明显长于安慰剂联合地塞米松组（安慰剂组）（中位数11.3个月vs.4.7个月; P
Background Lenalidomide is a structural analogue of thalidomide with similar but more potent biologic activity. This phase 3, placebo-controlled trial investigated the efficacy of lenalidomide plus dexamethasone in the treatment of relapsed or refractory multiple myeloma.Methods Of 351 patients who had received at least one previous antimyeloma therapy, 176 were randomly assigned to receive 25 mg of oral lenalidomide and 175 to receive placebo on days 1 to 21 of a 28-day cycle. In addition, all patients received 40 mg of oral dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for the first four cycles and subsequently, after the fourth cycle, only on days 1 to 4. Patients continued in the study until the occurrence of disease progression or unacceptable toxic effects. The primary end point was time to progression.Results The time to progression was significantly longer in the patients who received lenalidomide plus dexamethasone (lenalidomide group) than in those who received placebo plus dexamethasone (placebo group) (median, 11.3 months vs. 4.7 months; P