Lenalidomide and low-dose dexamethasone (Rd) are a standard treatment for older adults with multiple myeloma (MM). Lenalidomide monotherapy has rarely been evaluated for newly diagnosed transplant-ineligible MM patients. This multicenter phase II trial evaluated a response-adapted strategy for elderly patients with newly diagnosed MM without high-risk features. Patients were administered single-agent lenalidomide for the first 21 days of two 28-day cycles. Patients with progressive disease received Rd. The primary endpoint was progression-free survival using the uniform response assessment from the International Myeloma Working Group . Of the 34 enrolled patients, 28 were included in the efficacy analysis. The overall response rate (ORR, ≥ partial response [PR]) to single-agent lenalidomide or lenalidomide plus prednisone was 64.3%. Ten patients received Rd after disease progression, with an Rd ORR of 70%. The ORR of response-adapted lenalidomide-based therapy was 75%. After the median follow-up of 35.6 months, the median progression-free survival was 33.5 months (95% confidence interval [CI], 16.9-50.2), and the median overall survival was 51.8 months (95% CI, 22.0-81.6). The most common adverse event was neutropenia (46.7%), and 17 patients (56.7%) experienced infection including pneumonia. Response-adapted lenalidomide-based therapy was feasible in newly diagnosed, transplant-ineligible MM patients without high-risk features.

来那度胺和低剂量地塞米松 (Rd) 是老年人多发性骨髓瘤 (MM) 的标准治疗方法。来那度胺单药治疗很少用于新诊断的不适合移植的 MM 患者。这项多中心 II 期试验评估了针对新诊断 MM 且无高危特征的老年患者的反应适应策略。在两个 28 天周期的前 21 天，患者被给予单药来那度胺。患有进行性疾病的患者接受了 Rd。主要终点是使用国际骨髓瘤工作组的统一反应评估的无进展生存期。在纳入的 34 名患者中，有 28 名被纳入疗效分析。来那度胺单药或来那度胺加泼尼松的总体缓解率（ORR，≥部分缓解 [PR]）为 64.3%。10 名患者在疾病进展后接受 Rd，Rd ORR 为 70%。基于反应的来那度胺治疗的 ORR 为 75%。中位随访 35.6 个月后，中位无进展生存期为 33.5 个月（95% 置信区间 [CI]，16.9-50.2），中位总生存期为 51.8 个月（95% CI，22.0-81.6） . 最常见的不良事件是中性粒细胞减少症（46.7%），17 名患者（56.7%）出现包括肺炎在内的感染。在新诊断的、不符合移植条件且无高危特征的 MM 患者中，基于反应的来那度胺治疗是可行的。16.9-50.2），中位总生存期为 51.8 个月（95% CI，22.0-81.6）。最常见的不良事件是中性粒细胞减少症（46.7%），17 名患者（56.7%）出现包括肺炎在内的感染。在新诊断的、不符合移植条件且无高危特征的 MM 患者中，基于反应的来那度胺治疗是可行的。16.9-50.2），中位总生存期为 51.8 个月（95% CI，22.0-81.6）。最常见的不良事件是中性粒细胞减少症（46.7%），17 名患者（56.7%）出现包括肺炎在内的感染。在新诊断的、不符合移植条件且无高危特征的 MM 患者中，基于反应的来那度胺治疗是可行的。