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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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机构： [a]Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China [b]Department of Hematology, Shanghai Changzheng Hospital, Second Military Medical University, Shanghai, China [c]Department of Hematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China [d]Department of Hematology, The First Hospital of Xi’an Jiaotong University, Xi’an, Shanxi, China [e]Department of Hematology and Lymphoma Research Center, Peking University Third Hospital, Beijing, China [f]Department of Hematology, Peking University People’s Hospital, Beijing, China [g]Department of Hemotology, West China Hospital of Sichuan University, Chengdu, Sichuan, China [h]Department of Hemotology, The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China [i]Department of Hematology, Jinan Military General Hospital, Jinan, Shandong, China [j]Department of Hematology, Changhai Hospital, Second Military Medical University, Shanghai, China [k]Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China [l]Department of Hematology, Tangdu Hospital, Fourth Military Medical University, Xi’an, Shanxi, China [m]Department of Hematology, The First Hospital of Jilin University, Changchun, Jilin, China [n]Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China [o]Department of Lymphoma Center, Institute of Hematology and Blood Diseases Hospital, CAMS & PUMC, Tianjin, China [p]Department of Hematology, Beijing Hospital of the Ministry of Health, Beijing, China [q]Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China [r]Department of Hematology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China [s]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

摘要：

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). 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. 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. CPT plus TD could serve as a new therapeutic strategy for patients with RRMM. A randomized, double-blind, placebo-controlled confirmatory study is currently under way.

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出版当年[2017]版：

大类 | 3 区医学

小类 | 3 区药学 4 区肿瘤学

最新[2023]版：

大类 | 4 区医学

小类 | 3 区药学 4 区肿瘤学

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第一作者机构： [a]Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China

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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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