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- Title
Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study.
- Authors
Leng, Yun; Hou, Jian; Jin, Jie; Zhang, Mei; Ke, Xiaoyan; Jiang, Bin; Pan, Ling; Yang, Linhua; Zhou, Fang; Wang, Jianmin; Wang, Zhao; Liu, Li; Li, Wei; Shen, Zhixiang; Qiu, Lugui; Chang, Naibai; Li, Jianyong; Liu, Jing; Pang, Hongyan; Meng, Haitao
- Abstract
<bold>Purpose: </bold>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).<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusion: </bold>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.
- Subjects
THALIDOMIDE; MULTIPLE myeloma treatment; DEXAMETHASONE; DISEASE relapse; DRUG efficacy; COMBINATION drug therapy; THERAPEUTICS; ANTINEOPLASTIC agents; CARRIER proteins; COMPARATIVE studies; DRUG resistance in cancer cells; RESEARCH methodology; MEDICAL cooperation; MULTIPLE myeloma; PROGNOSIS; RESEARCH; EVALUATION research; RANDOMIZED controlled trials; BLIND experiment
- Publication
Cancer Chemotherapy & Pharmacology, 2017, Vol 79, Issue 6, p1141
- ISSN
0344-5704
- Publication type
journal article
- DOI
10.1007/s00280-017-3310-0