Aponermin or placebo in combination with thalidomide and dexamethasone in the treatment of relapsed or refractory multiple myeloma (CPT-MM301): a randomised, double-blinded, placebo-controlled, phase 3 trial

Autor: Zhongjun Xia, Yun Leng, Baijun Fang, Yang Liang, Wei Li, Chengcheng Fu, Linhua Yang, Xiaoyan Ke, Hua Jiang, Jianyu Weng, Li Liu, Yaozhong Zhao, Xuejun Zhang, Zhongxia Huang, Aichun Liu, Qingzhi Shi, Yuhuan Gao, Xiequn Chen, Ling Pan, Zhen Cai, Zhao Wang, Yafei Wang, Yaqun Fan, Ming Hou, Yigai Ma, Jianda Hu, Jing Liu, Jianfeng Zhou, Xiaohong Zhang, Haitao Meng, Xuzhang Lu, Fei Li, Hanyun Ren, Bintao Huang, Zonghong Shao, Hebing Zhou, Yu Hu, Shifang Yang, Xiangjun Zheng, Peng Wei, Hongyan Pang, Wei Yu, Yuzhang Liu, Sujun Gao, Lingzhi Yan, Yanping Ma, Hongmei Jing, Juan Du, Wei Ling, Jingyi Zhang, Weiwei Sui, Fuxu Wang, Xin Li, Wenming Chen
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: BMC Cancer, Vol 23, Iss 1, Pp 1-14 (2023)
Druh dokumentu: article
ISSN: 1471-2407
DOI: 10.1186/s12885-023-11489-8
Popis: Abstract Background Aponermin, a circularly permuted tumor necrosis factor-related apoptosis-inducing ligand, is a potential death receptor 4/5-targeted antitumour candidate. Previous phase 1/2 studies have demonstrated the efficacy of aponermin in patients with relapsed or refractory multiple myeloma (RRMM). To confirm the superiority of aponermin plus thalidomide and dexamethasone (aponermin group) over placebo plus thalidomide and dexamethasone (placebo group) in RRMM, a randomized, double-blinded, placebo controlled phase 3 trial was performed. Methods Four hundred seventeen patients with RRMM who had previously received at least two regimens were randomly assigned (2:1) to receive aponermin, thalidomide, and dexamethasone or placebo, thalidomide, and dexamethasone. The primary endpoint was progression-free survival (PFS). Key secondary endpoints included overall survival (OS) and overall response rate (ORR). Results A total of 415 patients received at least one dose of trial treatment (276 vs. 139). The median PFS was 5.5 months in the aponermin group and 3.1 months in the placebo group (hazard ratio, 0.62; 95% confidence interval [CI], 0.49–0.78; P
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