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Business Decision
Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)
A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China
1 other identifier
observational
176
1 country
17
Brief Summary
The primary objective of this study is to document efficacy and safety data in a real-world setting of Chinese multiple myeloma patients who have received at least one prior therapy treated with REVLIMID (lenalidomide).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2013
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJanuary 12, 2017
January 1, 2017
2.7 years
September 18, 2013
January 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
Assessment of PFS using IMWG Uniform Response Criteria
2 years after enrollment of last patient
Response Rates
Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria
2 years after enrollment of last patient
Secondary Outcomes (4)
Overall Survival (OS)
Two years after last patient enrolled
Time to Response (TTR) and Duration of Response (DOR)
Two years after last patient enrolled
Duration of Treatment with Revlimid
Two years after last patient enrolled.
Safety Profile of Revlimid
Two years after last patient enrolled
Study Arms (1)
Multiple Myeloma Patients Treated with Revlimid (lenalidomide)
Single Cohort of Multiple Myeloma Patients Treated with Revlimid
Interventions
Revlimid (lenalidomide) as prescribed in usual clinical practice
Eligibility Criteria
Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting
You may qualify if:
- Must understand and voluntarily sign written informed consent At least 18 years old at the time of signing informed consent Diagnosed with Multiple Myeloma Must have received at least one prior Multiple Myeloma treatment at the time of signing informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (17)
Peking Chao-Yang Hospital
Beijing, 100020, China
Peking University People's Hospital
Beijing, 100044, China
People's Liberation Army Hospital 307
Beijing, 100071, China
Beijing Hospital
Beijing, 100730, China
The Fisrt Hospital Of Jilin University
Changchun, 130031, China
Xiangya Hospital Central-South University
Changsha, 410008, China
Xinqiao Hospital, 3rd Military Medical University
Chongqing, 410008, China
NanFang Hospital of China Southern Medical University
Guangzhou, 510515, China
The First Affliated Hospital of Anhui Medical University
Hefei, 230032, China
Qilu Hospital of Shandong University
Jinan, 250012, China
The Affiliated Hospital of Mecical College Qingdao University
Qingdao, 266003, China
Shanghai Changzhen Hospital
Shanghai, 200003, China
The Second Affiliated Hospital Of China Medical University
Shenyang, 110004, China
The First Affiliated Hospital of Suzhou University
Suzhou, 215006, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, 830001, China
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
Wuhan, 430000, China
Tongji Medical College Huazhong University of Science & Technology
Wuhan, 430030, China
Related Publications (1)
Wang GM, Yang GZ, Huang ZX, Zhong YP, Jin FY, Liao AJ, Wang XM, Fu ZZ, Liu H, Li XL, Zhou JF, Zhang X, Hu Y, Meng FY, Huang XJ, Chen WM, Lu J. [A prospective multi-center trial of non-interventional and observational study of lenalidomide in Chinese patients with multiple myeloma]. Zhonghua Nei Ke Za Zhi. 2017 Jul 1;56(7):500-506. doi: 10.3760/cma.j.issn.0578-1426.2017.07.006. Chinese.
PMID: 28693058DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yu (Flora) Yao, MD
Celgene Pharmaceutical (Shanghai) Co. Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2013
First Posted
September 20, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
January 12, 2017
Record last verified: 2017-01