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A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma
Geng, Chuanying1; Hou, Jian2; Zhao, Yaozhong3,4,5; Ke, Xiaoyan6; Wang, Zhao7; Qiu, Lugui3,4,5; Xi, Hao2; Wang, Fuxu8; Wei, Na7; Liu, Yan6; Yang, Shifang9; Wei, Peng9; Zheng, Xiangjun9; Huang, Zhongxia1; Zhu, Bing9; Chen, Wen-Ming1
刊名AMERICAN JOURNAL OF HEMATOLOGY
2014-11-01
DOI10.1002/ajh.23822
89期:11页:1037-1042
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Hematology
资助者Beijing Sunbio Biotechnology Co., Ltd. ; Beijing Sunbio Biotechnology Co., Ltd.
研究领域[WOS]Hematology
关键词[WOS]APOPTOSIS-INDUCING LIGAND ; APO2L/TRAIL ; CELLS ; LENALIDOMIDE ; CASPASE-8 ; EFFICACY ; THERAPY ; CANCER ; SAFETY ; MEMBER
英文摘要

Circularly permuted TRAIL (CPT), a recombinant mutant of human Apo2L/TRAIL, is a novel antitumor candidate for multiple myeloma (MM) and other hematologic malignancies. In this phase II study, the safety and efficacy of CPT plus thalidomide was investigated in thalidomide-resistant MM patients. A total of 43 patients were recruited into three CPT plus thalidomide cohorts based on CPT dosage in sequence: 5 mg/kg (n=11), 8 mg/kg (n=17), and 10 mg/kg (n=15). CPT was administered via intravenous infusion on days 1-5, and thalidomide was given orally at 100 mg once daily in each 21-day cycle. The overall response rate (ORR) of 41 efficacy-evaluable patients was 22.0% (2 complete response, 3 near complete response, and 4 partial response). No significant difference in the ORR was observed among the three dose cohorts; however, the ORR tended to be higher with the higher-dose regimen. Median progression-free survival and median duration of response were 6.6 months and 6.1 months, respectively. The most common treatment-related adverse events (TRAEs) were neutropenia (46.5%), leukopenia (41.9%), fever (37.2%), elevated AST (32.6%), and elevated ALT (20.9%). TRAEs of Grade 3-4 were mainly neutropenia (18.6%), anemia (9.3%), elevated AST (7.0%), and leukopenia (4.7%). No significant differences were found in the incidence and severity of TRAEs among the three cohorts. In conclusion, CPT plus thalidomide was well tolerated with no occurrence of dose-limiting toxicities and demonstrated promising antitumor activity in RRMM patients. CPT at 10 mg/kg for 5 days in combination with thalidomide and dexamethason will be studied in the next clinical trial. Am. J. Hematol. 89:1037-1042, 2014. (c) 2014 Wiley Periodicals, Inc.

语种英语
资助者Beijing Sunbio Biotechnology Co., Ltd. ; Beijing Sunbio Biotechnology Co., Ltd.
WOS记录号WOS:000344010100009
引用统计
被引频次:17[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/64995
专题北京大学第三临床医学院_血液内科
作者单位1.Capital Med Univ, Beijing Chao Yang Hosp, Dept Hematol, Beijing 100020, Peoples R China
2.Second Mil Med Univ, Chang Zheng Hosp, Dept Hematol, Shanghai, Peoples R China
3.CAMS, Inst Hematol, Dept Lymphoma Ctr, Tianjin, Peoples R China
4.CAMS, Blood Dis Hosp, Tianjin, Peoples R China
5.PUMC, Tianjin, Peoples R China
6.Hebei Med Univ, Hosp 2, Dept Hematol, Hebei, Peoples R China
7.Beijing Sunbio Biotechnol Co Ltd, Beijing, Peoples R China
8.Peking Univ, Dept Hematol, Hosp 3, Beijing 100871, Peoples R China
9.Capital Med Univ, Beijing Friendship Hosp, Dept Hematol, Beijing, Peoples R China
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Geng, Chuanying,Hou, Jian,Zhao, Yaozhong,et al. A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma[J]. AMERICAN JOURNAL OF HEMATOLOGY,2014,89(11):1037-1042.
APA Geng, Chuanying.,Hou, Jian.,Zhao, Yaozhong.,Ke, Xiaoyan.,Wang, Zhao.,...&Chen, Wen-Ming.(2014).A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma.AMERICAN JOURNAL OF HEMATOLOGY,89(11),1037-1042.
MLA Geng, Chuanying,et al."A multicenter, open-label phase II study of recombinant CPT (Circularly Permuted TRAIL) plus thalidomide in patients with relapsed and refractory multiple myeloma".AMERICAN JOURNAL OF HEMATOLOGY 89.11(2014):1037-1042.
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