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Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study

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单位: [1]Department of Hematology, Beijing Chao‑Yang Hospital, Capital Medical University, Beijing, China [2]Department of Hematology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China [3]Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China [4]Department of Hematology, The First Hospital of Xi’an Jiaotong University, Xi’an, Shanxi, China [5]Department of Hematology and Lymphoma Research Center, Peking University Third Hospital, Beijing, China [6]Department of Hematology, Peking University People’s Hospital, Beijing, China [7]Department of Hemotology, West China Hospital of Sichuan University, Chengdu, Sichuan, China [8]Department of Hemotology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China [9]Department of Hematology, Jinan Military General Hospital, Jinan, Shandong, China [10]Department of Hematology, Changhai Hospital, Second Military Medical University, Shanghai, China [11]Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [12]Department of Hematology, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shanxi, China [13]Department of Hematology, The First Hospital of Jilin University, Changchun, Jilin, China [14]Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China [15]Department of Lymphoma Center, Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, Tianjin, China [16]Department of Hematology, Beijing Hospital of the Ministry of Health, Beijing, China [17]Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China [18]Department of Hematology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China [19]Beijing Sunbio Biotech Co. Ltd., Beijing, China
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关键词: Recombinant human circularly permuted TRAIL Multiple myeloma Thalidomide Dexamethasone Phase 2 clinical trials

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Purpose Circularly permuted TRAIL (CPT) has exhibited promising efficacy as a mono-therapy or in combination with thalidomide for patients with multiple myeloma (MM). In this phase 2 study, the safety and efficacy of CPT in combination with thalidomide and dexamethasone (CPT+TD) was evaluated in patients with pretreated relapsed/refractory MM (RRMM). Methods Patients who received at least two previous therapies for MM were randomly assigned at a 2: 1 ratio to receive treatment with CPT + TD or thalidomide and dexamethasone (TD). The primary endpoint was the overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), duration of response (DOR) and safety. Results Overall, 47 patients were assigned to the CPT + TD group, and 24 patients were recruited to the TD group. The ORR in the CPT + TD group was 38.3 vs. 25.0% in the TD group. The median PFS time was 6.7 months for the CPT + TD group and 3.1 months for the TD group. The median DORs for the CPT + TD and TD groups were 7.1 and 3.2 months, respectively. Most of the adverse effects (AEs) were grade 1 or 2. Serious AEs were reported in 19.7% of the patients. No treatment-related deaths were reported. Conclusion CPT plus TD could serve as a new therapeutic strategy for patients with RRMM.A randomized, doubleblind, placebo-controlled confirmatory study is currently under way.

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出版当年[2016]版:
大类 | 3 区 医学
小类 | 3 区 药学 4 区 肿瘤学
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 肿瘤学 4 区 药学
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出版当年[2015]版:
Q2 PHARMACOLOGY & PHARMACY Q3 ONCOLOGY
最新[2023]版:
Q2 PHARMACOLOGY & PHARMACY Q3 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2015版] 出版当年五年平均[2011-2015] 出版前一年[2014版] 出版后一年[2016版]

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第一作者单位: [1]Department of Hematology, Beijing Chao‑Yang Hospital, Capital Medical University, Beijing, China
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