Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)
- Registration Number
- NCT01947309
- Lead Sponsor
- Celgene
- 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).
- Detailed Description
This registry is prospective, multi-center, observational study and will collect efficacy and safety data on multiple myeloma adult patients who have received at least one prior therapy and take REVLIMID as part of standard care associated with patients' treatment in order to characterize the use, efficacy and outcomes of REVLIMID treatment.
The registry will capture data from 600 patients being prescribed REVLIMID in specified hospitals and all patients will be followed in the registry for two years after enrollment of the last patient.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 176
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Multiple Myeloma Patients Treated with Revlimid (lenalidomide) Revlimid (lenalidomide) Single Cohort of Multiple Myeloma Patients Treated with Revlimid
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) 2 years after enrollment of last patient Assessment of PFS using IMWG Uniform Response Criteria
Response Rates 2 years after enrollment of last patient Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria
- Secondary Outcome Measures
Name Time Method 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. Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID
Safety Profile of Revlimid Two years after last patient enrolled All Adverse Events (AEs) and occurrence of second primary malignancies (SPM)
Trial Locations
- Locations (17)
Beijing Hospital
🇨🇳Beijing, China
Xiangya Hospital Central-South University
🇨🇳Changsha, China
Shanghai Changzhen Hospital
🇨🇳Shanghai, China
The Affiliated Hospital of Mecical College Qingdao University
🇨🇳Qingdao, China
Peking Chao-Yang Hospital
🇨🇳Beijing, China
People's Liberation Army Hospital 307
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
The Second Affiliated Hospital Of China Medical University
🇨🇳Shenyang, China
Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
🇨🇳Wuhan, China
The Fisrt Hospital Of Jilin University
🇨🇳Changchun, China
NanFang Hospital of China Southern Medical University
🇨🇳Guangzhou, China
The First Affliated Hospital of Anhui Medical University
🇨🇳Hefei, China
The First Affiliated Hospital of Suzhou University
🇨🇳Suzhou, China
People's Hospital of Xinjiang Uygur Autonomous Region
🇨🇳Urumqi, China
Tongji Medical College Huazhong University of Science & Technology
🇨🇳Wuhan, China
Xinqiao Hospital, 3rd Military Medical University
🇨🇳Chongqing, China
Qilu Hospital of Shandong University
🇨🇳Jinan, China