Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma
Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma
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DOI：
10.1182/blood-2005-07-2817
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发表时间：
2005-12-15
期刊：
影响因子：
20.3
通讯作者：
Gertz, MA
中科院分区：
文献类型：
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作者：
Rajkumar, SV;Hayman, SR;Gertz, MA
我们报告一项使用来那度胺加地塞米松（Rev/ Dex）作为骨髓瘤初始治疗的2期试验的结果。34名患者入组。来那度胺在28天周期的第1天至第21天每日口服25mg。地塞米松在每个周期的第1 ~ 4天、第9 ~ 12天、第17 ~ 20天每日口服40 mg。客观反应定义为血清单克隆蛋白水平下降50%或以上，尿M蛋白水平下降至少90%或低于200mg /24小时，间隔至少4周连续两次检测证实。34例患者中有31例达到客观缓解，其中2例（6%）达到完全缓解（CR）， 11例（32%）达到非常好的部分缓解和接近完全缓解标准，总体客观缓解率为91%。其余3例未达到客观缓解的患者中，2例有轻微缓解（MR）， 1例病情稳定。47%的患者出现III级或更高级别的非血液学毒性，最常见的是疲劳（15%）、肌肉无力（6%）、焦虑（6%）、肺炎（6%）和皮疹（6%）。Rev/Dex是治疗新诊断的骨髓瘤的一种高度活跃的方案，副作用可控。
We report the results of a phase 2 trial using lenalidomide plus dexamethasone (Rev/ Dex) as initial therapy for myeloma. Thirty-four patients were enrolled. Lenalidomide was given orally 25 mg daily on days 1 to 21 of a 28-day cycle. Dexamethasone was given orally 40 mg daily on days 1 to 4,9 to 12, and 17 to 20 of each cycle. Objective response was defined as a decrease in serum monoclonal protein level by 50% or greater and a decrease in urine M protein level by at least 90% or to a level less than 200 mg/24 hours, confirmed by 2 consecutive determinations at least 4 weeks apart. Thirty-one of 34 patients achieved an objective response, including 2 (6%) achieving complete response (CR) and 11 (32%) meeting criteria for both very good partial response and near complete response, resulting in an overall objective response rate of 91%. Of the 3 remaining patients not achieving an objective response, 2 had minor response (MR) and one had stable disease. Forty-seven percent of patients experienced grade III or higher nonhematologic toxicity, most commonly fatigue (15%), muscle weakness (6%), anxiety (6%), pneumonitis (6%), and rash (6%). Rev/Dex is a highly active regimen with manageable side effects in the treatment of newly diagnosed myeloma.