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Drugs. 2017 Sep;77(13):1473-1480. doi: 10.1007/s40265-017-0795-0.
Lenalidomide (Revlimid) is an immunomodulatory drug with multiple mechanisms of action against multiple myeloma. It is a thalidomide analogue, with improved potency and reduced toxicity compared with thalidomide. In the EU and USA, lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem-cell transplantation (ASCT). In the pivotal, phase 3 IFM 2005-02 and CALGB 100104 trials, lenalidomide maintenance therapy after ASCT administered until disease progression significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo in patients with newly diagnosed multiple myeloma. These results are generally supported by those of the phase 3 GIMEMA and Myeloma XI trials. Lenalidomide maintenance therapy significantly prolonged overall survival in CALGB 100104 but not in IFM 2005-02. However, a meta-analysis of patient-level data from IFM 2005-02, CALGB 100104 and GIMEMA showed an overall survival benefit with this therapy. Lenalidomide maintenance therapy had a manageable tolerability profile in the pivotal trials. Grade 3/4 haematological adverse events and grade 3 nonhaematological adverse events were more common with lenalidomide than with placebo. Lenalidomide increased the risk of a second primary cancer, but the survival benefits outweigh this risk. In conclusion, lenalidomide maintenance therapy after ASCT until disease progression prolongs PFS and overall survival in patients with newly diagnosed multiple myeloma. Therefore, lenalidomide offers a valuable maintenance treatment option for this population.
来那度胺（雷利度胺）是一种具有多种作用机制的免疫调节剂，可用于治疗多发性骨髓瘤。它是沙利度胺的类似物，与沙利度胺相比，其活性更强，毒性更低。在欧盟和美国，来那度胺单药治疗适用于已接受自体干细胞移植（ASCT）的新诊断多发性骨髓瘤患者的维持治疗。在关键性、III 期 IFM 2005-02 和 CALGB 100104 试验中，与安慰剂相比，ASCT 后给予来那度胺维持治疗直至疾病进展可显著延长无进展生存期（PFS；主要终点），新诊断的多发性骨髓瘤患者。这些结果通常得到了 GIMEMA 和 Myeloma XI 试验的支持。在 CALGB 100104 中，来那度胺维持治疗显著延长了总生存期，但在 IFM 2005-02 中则没有。然而，IFM 2005-02、CALGB 100104 和 GIMEMA 患者水平数据的荟萃分析显示，这种治疗有总生存获益。在关键性试验中，来那度胺维持治疗具有可管理的耐受性。来那度胺比安慰剂更常见 3/4 级血液学不良事件和 3 级非血液学不良事件。来那度胺增加了发生第二原发癌的风险，但生存获益超过了这一风险。总之，ASCT 后至疾病进展期间给予来那度胺维持治疗可延长新诊断多发性骨髓瘤患者的 PFS 和总生存期。因此，来那度胺为该人群提供了一种有价值的维持治疗选择。
