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Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial

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机构： [1]Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, #8, the South Road of Workers Stadium of Chaoyang District, Beijing, 100020, China. [2]Department of Hematology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [3]Department of Hematology, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, China. [4]Department of Hematology, The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. [5]Department of Hematology, The First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, China. [6]Department of Hematology, Zhongshan Hospital Affiliated to Xiamen University, Xiamen, China. [7]Department of Hematology, The First People's Hospital of Foshan, Guangzhou, China. [8]Department of Hematology, The First Affiliated Hospital of University of South China, Hengyang, China. [9]Department of Hematology, Qilu Hospital of Shandong University, Jinan, China. [10]Department of Hematology, Shanxi Provincial Cancer Hospital, Taiyuan, China. [11]Department of Hematology, Yunnan Cancer Hospital, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Center, Kunming, China. [12]Department of Hematology, The Affiliated Hospital of Qingdao University, Qingdao, China. [13]Department of Hematology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China. [14]Department of Hematology, Second Hospital of Shanxi Medical University, Taiyuan, China. [15]Department of Hematology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China. [16]Department of Hematology, The First Affiliated Hospital of Gannan Medical University, Ganzhou, China. [17]Department of Hematology, Wuxi People's Hospital, Wuxi, China. [18]Department of Hematology, Peking University Third Hospital, Beijing, China. [19]Department of Hematology, The Third Hospital of Hebei Medical University, Shijiazhuang, China. [20]Department of Hematology, Shengjing Hospital of China Medical University, Shenyang, China. [21]Department of Hematology, Weifang People's Hospital, Weifang, China. [22]Department of Hematology, Zhangzhou Municicap Hospital of Fujian Province, Zhangzhou, China. [23]Department of Hematology, The First Affiliated Hospital of Xinjiang Medical University, Urumchi, China. [24]Department of Hematology, Liaocheng People's Hospital, Liaocheng, China. [25]Department of Hematology, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China. [26]Department of Geriatric Hematologic Oncology, Guangzhou First People's Hospital, Guangzhou, China. [27]Department of Hematopathology, Guizhou Provincial People's Hospital, Guiyang, China. [28]Department of Hematology, Henan Cancer Hospital, Affiliated Cancer Hospital of Zhenghzou University, Zhengzhou, China. [29]Department of Hemolymph, Weihai Central Hospital, Weihai, China. [30]Department of Hematology, Xi'an Central Hospital, Xi'an, China. [31]Bone Marrow Transplantation Center, the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. [32]Clinical Research Center, Qilu Pharmaceutical Co., Ltd., Jinan, China. [33]Department of Hematology, First Affiliated Hospital of Sun Yat-Sen University, #58, The 2nd Zhongshan Road, Yuexiu District, Guangzhou, 510062, China.

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关键词： Pomalidomide Generic drug Relapse and/or refractory multiple myeloma (RRMM) Dexamethasone

摘要：

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.© 2023. The Author(s).

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大类 | 3 区医学

小类 | 3 区血液学

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最新[2023]版：

Q2 HEMATOLOGY

影响因子： 3 最新[2023版] 3.1 最新五年平均 3 出版当年[2023版] 0 出版当年五年平均 3 出版前一年[2023版]

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第一作者机构： [1]Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, #8, the South Road of Workers Stadium of Chaoyang District, Beijing, 100020, China.

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Efficacy and safety of generic pomalidomide plus low-dose dexamethasone in relapsed or refractory multiple myeloma: a multicenter, open-label, single-arm trial

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