Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, #8, the South Road of Workers Stadium of Chaoyang District, Beijing, 100020, China.
Department of Hematology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Ann Hematol. 2024 Mar;103(3):855-868. doi: 10.1007/s00277-023-05558-y. Epub 2023 Dec 19.
This multicenter, open-label, single-arm trial (ClinicalTrials.gov, NCT05236621) was conducted to confirm the efficacy and safety of generic pomalidomide plus dexamethasone in Chinese patients with relapsed or refractory multiple myeloma (RRMM). Total 79 eligible RRMM patients were planned to be included. Patients were treated with generic pomalidomide (4 mg daily on days 1-21, orally) and low-dose dexamethasone (40 mg/day on days 1, 8, 15, and 22, orally; 20 mg for patients aged > 75 years) in 28-day cycles until disease progression with a maximum treatment duration of 2 years. The primary endpoint is the overall response rate (ORR) assessed by the independent review committee per the 2016 International Myeloma Working Group guidelines. A total of 85 eligible patients were included in this study from 32 centers in China, with a median age of 62.0 (range, 39-76) years, a median prior line of therapy of 4 (range, 1-16), and 41.2% patients with high-risk cytogenetics. The ORR was 38.8% (95% confidence interval (CI), 28.44-50.01). The disease control rate was 67.1% (95% CI, 56.02-76.87), meanwhile, the median progression-free survival was 5.55 months (95% CI, 3.68-7.52). Among the treatment-related adverse events (TRAEs), infective pneumonia (17.6%) was the most frequent non-hematologic adverse event, while a decrease in neutrophil count (52.9%) was the most common grade ≥ 3 TRAE. The study results indicated that the generic pomalidomide demonstrated consistent efficacy and a safety profile similar to the branded pomalidomide when combined with low-dose dexamethasone in Chinese RRMM patients.Registration number ClinicalTrials.gov NCT05236621, retrospectively registered on February 11, 2022.
这项多中心、开放性、单臂试验（ClinicalTrials.gov，NCT05236621）旨在确认在中国复发或难治性多发性骨髓瘤（RRMM）患者中，通用泊马度胺联合低剂量地塞米松的疗效和安全性。计划纳入 79 名符合条件的 RRMM 患者。患者接受通用泊马度胺（第 1-21 天每日 4mg，口服）和低剂量地塞米松（第 1、8、15 和 22 天每日 40mg，口服；年龄>75 岁的患者为 20mg）治疗，每 28 天为一个周期，直至疾病进展，最长治疗时间为 2 年。主要终点是根据 2016 年国际骨髓瘤工作组指南由独立审查委员会评估的总体缓解率（ORR）。本研究共纳入来自中国 32 个中心的 85 名符合条件的患者，中位年龄为 62.0（范围 39-76）岁，中位既往治疗线数为 4（范围 1-16），41.2%的患者具有高危细胞遗传学特征。ORR 为 38.8%（95%置信区间[CI]，28.44-50.01）。疾病控制率为 67.1%（95%CI，56.02-76.87），同时，中位无进展生存期为 5.55 个月（95%CI，3.68-7.52）。在与治疗相关的不良事件（TRAEs）中，感染性肺炎（17.6%）是最常见的非血液学不良事件，而中性粒细胞计数减少（52.9%）是最常见的≥3 级 TRAE。研究结果表明，在复发难治性多发性骨髓瘤中国患者中，与硼替佐米联合低剂量地塞米松相比，通用泊马度胺联合低剂量地塞米松显示出一致的疗效和安全性。注册号 ClinicalTrials.gov NCT05236621，于 2022 年 2 月 11 日进行了回顾性注册。
