Clinical trial NCT01947309: Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)
Official title: A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Myeloma
Keywords: Revlimid, lenalidomide, multiple myeloma, PFS, Response Rates
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2013-09-20
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 years after enrollment of last patient
measure: Response Rates
timeFrame: 2 years after enrollment of last patient
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Two years after last patient enrolled
measure: Time to Response (TTR) and Duration of Response (DOR)
timeFrame: Two years after last patient enrolled
measure: Duration of Treatment with Revlimid
timeFrame: Two years after last patient enrolled.
measure: Safety Profile of Revlimid
timeFrame: Two years after last patient enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Chao-Yang Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: People's Liberation Army Hospital 307
city: Beijing
country: China
facility: Beijing Hospital
city: Changchun
country: China
facility: The Fisrt Hospital Of Jilin University
city: Changsha
country: China
facility: Xiangya Hospital Central-South University
city: Chongqing
country: China
facility: Xinqiao Hospital, 3rd Military Medical University
city: Guangzhou
country: China
facility: NanFang Hospital of China Southern Medical University
city: Hefei
country: China
facility: The First Affliated Hospital of Anhui Medical University
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Qingdao
country: China
facility: The Affiliated Hospital of Mecical College Qingdao University
city: Shanghai
country: China
facility: Shanghai Changzhen Hospital
city: Shenyang
country: China
facility: The Second Affiliated Hospital Of China Medical University
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
city: Urumqi
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
city: Wuhan
country: China
facility: Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
city: Wuhan
country: China
facility: Tongji Medical College Huazhong University of Science & Technology
Study officials:
affiliation: Celgene Pharmaceutical (Shanghai) Co. Ltd.
name: Yu (Flora) Yao, MD
role: STUDY_DIRECTOR
References:
citation: 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.