印度代购提示，本品包括来那度胺(LEN)作为一线治疗方案已成为多发性骨髓瘤(MM)的一种标准治疗，但对于LEN难治性患者的治疗选择有限，泊马度胺联合地塞米松(Pd)在复发难治性多发性骨髓瘤中显示出初步疗效。目前，中国MM患者中尚缺乏疗效数据，研究人员进行了一项多中心、单臂研究，以进一步研究Pd联合泊马度胺在中国复发难治性多发性骨髓瘤患者中的疗效和安全性。

The inclusion of Lenalidomide (LEN) as first-line therapy has become a standard treatment for multiple myeloma (MM), but treatment options for LEN refractory patients are limited, and pemalidomide in combination with dexamethasone (Pd) has shown preliminary efficacy in relapsed and refractory multiple myeloma. We conducted a multicenter, single-arm study to further investigate the efficacy and safety of Pd combined with permadomide in patients with relapsed and refractory multiple myeloma in China.

泊马度胺

　　印度代购提示，本品本项Ⅱ期研究在2017年2月至2019年2月期间开展，入组成人复发难治性多发性骨髓瘤患者。在28天周期的第1-21天，口服给予泊马度胺4 mg，每日一次，持续至疾病进展(PD)或发生不可耐受的不良事件(AE)。在每个周期的第1、8、15和22天口服地塞米松，剂量为40 mg/天。客观缓解率(ORR)为主要终点。

　　印度代购提示，本品研究纳入74例患者，所有患者既往均接受过来那度胺，81%的患者对来那度胺耐药。此外，51.4%的患者伴有肾损伤，33.8%的患者为高危复发难治性多发性骨髓瘤。中位随访11.1个月(9.9-12.7)，总ORR为36.5%，高危MM患者的ORR为32.0%，伴肾损害的MM患者ORR为31.6%。中位无进展生存期(mPFS)为6.4个月(95%CI 3.8, 10.1)。最常见的3~4级治疗相关AE是中性粒细胞减少(62.2%)和血小板减少(28.4%)。肺部感染(17.6%)是最常见的3~4级非血液学TEAE。未观察到既往未报告的AE，未出现静脉血栓栓塞。

The study included 74 patients, all of whom had previously received lenalidomide, and 81% of whom were resistant to lenalidomide. In addition, 51.4% of patients had renal injury and 33.8% had high-risk, relapsing and refractory multiple myeloma. The median follow-up was 11.1 months (9.9-12.7), and the total ORR was 36.5%, 32.0% in high-risk MM patients and 31.6% in MM patients with renal impairment. The median progression-free survival (mPFS) was 6.4 months (95%CI 3.8, 10.1). The most common grade 3-4 treatment-related AE were neutropenia (62.2%) and thrombocytopenia (28.4%). Pulmonary infection (17.6%) was the most common grade 3 to 4 non-hematologic TEAE. No previously unreported AE was observed and no venous thromboembolism was observed.