Observational Registry Study of Chinese Patients Treated With Revlimid (Lenalidomide)

NCT ID: NCT01947309

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multiple Myeloma Patients Treated with Revlimid (lenalidomide)

Single Cohort of Multiple Myeloma Patients Treated with Revlimid

Revlimid (lenalidomide)

Intervention Type DRUG

Revlimid (lenalidomide) as prescribed in usual clinical practice

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Revlimid (lenalidomide)

Revlimid (lenalidomide) as prescribed in usual clinical practice

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yu (Flora) Yao, MD

Role: STUDY_DIRECTOR

Celgene Pharmaceutical (Shanghai) Co. Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking Chao-Yang Hospital

Beijing, , China

Site Status

Peking University People's Hospital

Beijing, , China

Site Status

People's Liberation Army Hospital 307

Beijing, , China

Site Status

Beijing Hospital

Beijing, , China

Site Status

The Fisrt Hospital Of Jilin University

Changchun, , China

Site Status

Xiangya Hospital Central-South University

Changsha, , China

Site Status

Xinqiao Hospital, 3rd Military Medical University

Chongqing, , China

Site Status

NanFang Hospital of China Southern Medical University

Guangzhou, , China

Site Status

The First Affliated Hospital of Anhui Medical University

Hefei, , China

Site Status

Qilu Hospital of Shandong University

Jinan, , China

Site Status

The Affiliated Hospital of Mecical College Qingdao University

Qingdao, , China

Site Status

Shanghai Changzhen Hospital

Shanghai, , China

Site Status

The Second Affiliated Hospital Of China Medical University

Shenyang, , China

Site Status

The First Affiliated Hospital of Suzhou University

Suzhou, , China

Site Status

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, , China

Site Status

Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology

Wuhan, , China

Site Status

Tongji Medical College Huazhong University of Science & Technology

Wuhan, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 28693058 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NIPMS-RV-CN-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lenalidomide Maintenance in Plasma Cell Myeloma
NCT02538198 ACTIVE_NOT_RECRUITING PHASE2