PMID- 28500554
OWN - NLM
STAT- MEDLINE
DCOM- 20170613
LR  - 20170613
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 79
IP  - 6
DP  - 2017 Jun
TI  - Circularly permuted TRAIL plus thalidomide and dexamethasone versus thalidomide 
      and dexamethasone for relapsed/refractory multiple myeloma: a phase 2 study.
PG  - 1141-1149
LID - 10.1007/s00280-017-3310-0 [doi]
AB  - 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, double-blind, 
      placebo-controlled confirmatory study is currently under way.
FAU - Leng, Yun
AU  - Leng Y
AD  - Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China.
FAU - Hou, Jian
AU  - Hou J
AD  - Department of Hematology, Shanghai Changzheng Hospital, Second Military Medical 
      University, Shanghai, China.
FAU - Jin, Jie
AU  - Jin J
AD  - Department of Hematology, The First Affiliated Hospital, College of Medicine, 
      Zhejiang University, Hangzhou, Zhejiang, China.
FAU - Zhang, Mei
AU  - Zhang M
AD  - Department of Hematology, The First Hospital of Xi'an Jiaotong University, Xi'an, 
      Shanxi, China.
FAU - Ke, Xiaoyan
AU  - Ke X
AD  - Department of Hematology and Lymphoma Research Center, Peking University Third 
      Hospital, Beijing, China.
FAU - Jiang, Bin
AU  - Jiang B
AD  - Department of Hematology, Peking University People's Hospital, Beijing, China.
FAU - Pan, Ling
AU  - Pan L
AD  - Department of Hemotology, West China Hospital of Sichuan University, Chengdu, 
      Sichuan, China.
FAU - Yang, Linhua
AU  - Yang L
AD  - Department of Hemotology, The Second Hospital of Shanxi Medical University, 
      Taiyuan, Shanxi, China.
FAU - Zhou, Fang
AU  - Zhou F
AD  - Department of Hematology, Jinan Military General Hospital, Jinan, Shandong, 
      China.
FAU - Wang, Jianmin
AU  - Wang J
AD  - Department of Hematology, Changhai Hospital, Second Military Medical University, 
      Shanghai, China.
FAU - Wang, Zhao
AU  - Wang Z
AD  - Department of Hematology, Beijing Friendship Hospital, Capital Medical 
      University, Beijing, China.
FAU - Liu, Li
AU  - Liu L
AD  - Department of Hematology, Tangdu Hospital, Fourth Military Medical University, 
      Xi'an, Shanxi, China.
FAU - Li, Wei
AU  - Li W
AD  - Department of Hematology, The First Hospital of Jilin University, Changchun, 
      Jilin, China.
FAU - Shen, Zhixiang
AU  - Shen Z
AD  - Department of Hematology, Ruijin Hospital, Shanghai Jiaotong University, 
      Shanghai, China.
FAU - Qiu, Lugui
AU  - Qiu L
AD  - Department of Lymphoma Center, Institute of Hematology and Blood Diseases 
      Hospital, CAMS & PUMC, Tianjin, China.
FAU - Chang, Naibai
AU  - Chang N
AD  - Department of Hematology, Beijing Hospital of the Ministry of Health, Beijing, 
      China.
FAU - Li, Jianyong
AU  - Li J
AD  - Department of Hematology, Jiangsu Province Hospital, The First Affiliated 
      Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.
FAU - Liu, Jing
AU  - Liu J
AD  - Department of Hematology, The Third Xiangya Hospital of Central South University, 
      Changsha, Hunan, China.
FAU - Pang, Hongyan
AU  - Pang H
AD  - Beijing Sunbio Biotech Co. Ltd., Beijing, China.
FAU - Meng, Haitao
AU  - Meng H
AD  - Department of Hematology, The First Affiliated Hospital, College of Medicine, 
      Zhejiang University, Hangzhou, Zhejiang, China.
FAU - Wei, Peng
AU  - Wei P
AD  - Beijing Sunbio Biotech Co. Ltd., Beijing, China.
FAU - Jiang, Hua
AU  - Jiang H
AD  - Department of Hematology, Shanghai Changzheng Hospital, Second Military Medical 
      University, Shanghai, China.
FAU - Liu, Yan
AU  - Liu Y
AD  - Department of Hematology and Lymphoma Research Center, Peking University Third 
      Hospital, Beijing, China.
FAU - Zheng, Xiangjun
AU  - Zheng X
AD  - Beijing Sunbio Biotech Co. Ltd., Beijing, China.
FAU - Yang, Shifang
AU  - Yang S
AD  - Beijing Sunbio Biotech Co. Ltd., Beijing, China.
FAU - Chen, Wenming
AU  - Chen W
AUID- ORCID: 0000-0001-9070-9280
AD  - Department of Hematology, Beijing Chao-Yang Hospital, Capital Medical University, 
      Beijing, China. xybxx@ccmu.edu.cn.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170512
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Antineoplastic Agents, Hormonal)
RN  - 0 (TNF-Related Apoptosis-Inducing Ligand)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/immunology
MH  - Antineoplastic Agents, Hormonal/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Dexamethasone/administration & dosage
MH  - Disease-Free Survival
MH  - Double-Blind Method
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Multiple Myeloma/*drug therapy
MH  - Recurrence
MH  - TNF-Related Apoptosis-Inducing Ligand/administration & dosage/immunology
MH  - Thalidomide/administration & dosage
OTO - NOTNLM
OT  - Dexamethasone
OT  - Multiple myeloma
OT  - Phase 2 clinical trials
OT  - Recombinant human circularly permuted TRAIL
OT  - Thalidomide
EDAT- 2017/05/14 06:00
MHDA- 2017/06/14 06:00
CRDT- 2017/05/14 06:00
PHST- 2017/01/17 00:00 [received]
PHST- 2017/04/12 00:00 [accepted]
PHST- 2017/05/14 06:00 [pubmed]
PHST- 2017/06/14 06:00 [medline]
PHST- 2017/05/14 06:00 [entrez]
AID - 10.1007/s00280-017-3310-0 [pii]
AID - 10.1007/s00280-017-3310-0 [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2017 Jun;79(6):1141-1149. doi: 
      10.1007/s00280-017-3310-0. Epub 2017 May 12.