Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study
机构：[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浙江大学医学院附属第一医院[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四川大学华西医院[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中国人民解放军联勤保障部队第九六〇医院[10]Department of Hematology, Changhai Hospital, Second Military Medical University, Shanghai, China[11]Department of Hematology, Beijing Friendship Hospital, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[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江苏省人民医院[18]Department of Hematology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China[19]Beijing Sunbio Biotech Co. Ltd., Beijing, China
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.
基金：
Beijing Sunbio Biotech Co. Ltd sponsored this
clinical study and was responsible for medical monitoring and auditing.
第一作者机构：[1]Department of Hematology, Beijing Chao‑Yang Hospital, Capital Medical University, Beijing, China
通讯作者：
推荐引用方式(GB/T 7714)：
Yun Leng,Jian Hou,Jie Jin,et al.Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study[J].Cancer Chemotherapy And Pharmacology.2017,79(6):1141-1149.doi:10.1007/s00280-017-3310-0.
APA：
Yun Leng,Jian Hou,Jie Jin,Mei Zhang,Xiaoyan Ke...&Wenming Chen.(2017).Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study.Cancer Chemotherapy And Pharmacology,79,(6)
MLA：
Yun Leng,et al."Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study".Cancer Chemotherapy And Pharmacology 79..6(2017):1141-1149
