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

January 10, 2017 updated by: Celgene

A Non-interventional, Observational Post-marketing Registry of Multiple Myeloma Adult Patients Treated With Revlimid (Lenalidomide) in China

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100044
        • Peking University People's Hospital
      • Beijing, China, 100730
        • Beijing Hospital
      • Beijing, China, 100020
        • Peking Chao-Yang Hospital
      • Beijing, China, 100071
        • People's Liberation Army Hospital 307
      • Changchun, China, 130031
        • The Fisrt Hospital Of Jilin University
      • Changsha, China, 410008
        • Xiangya Hospital Central-South University
      • Chongqing, China, 410008
        • Xinqiao Hospital, 3rd Military Medical University
      • Guangzhou, China, 510515
        • NanFang Hospital of China Southern Medical University
      • Hefei, China, 230032
        • The First Affliated Hospital Of Anhui Medical University
      • Jinan, China, 250012
        • Qilu Hospital of Shandong University
      • Qingdao, China, 266003
        • The Affiliated Hospital of Mecical College Qingdao University
      • Shanghai, China, 200003
        • Shanghai Changzhen Hospital
      • Shenyang, China, 110004
        • The Second Affiliated Hospital of China Medical University
      • Suzhou, China, 215006
        • The first affiliated hospital of suzhou University
      • Urumqi, China, 830001
        • People's Hospital of Xinjiang Uygur Autonomous Region
      • Wuhan, China, 430000
        • Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology
      • Wuhan, China, 430030
        • Tongji Medical College Huazhong University of Science & Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult Chinese Patients with Multiple Myeloma Treated with Revlimid (Lenalidomide) in a Postmarketing setting

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Multiple Myeloma Patients Treated with Revlimid (lenalidomide)
Single Cohort of Multiple Myeloma Patients Treated with Revlimid
Drug: Revlimid (lenalidomide)
Revlimid (lenalidomide) as prescribed in usual clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: 2 years after enrollment of last patient
Assessment of PFS using IMWG Uniform Response Criteria
2 years after enrollment of last patient
Response Rates
Time Frame: 2 years after enrollment of last patient
Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria
2 years after enrollment of last patient

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Two years after last patient enrolled
Two years after last patient enrolled
Time to Response (TTR) and Duration of Response (DOR)
Time Frame: Two years after last patient enrolled
Two years after last patient enrolled
Duration of Treatment with Revlimid
Time Frame: Two years after last patient enrolled.
Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID
Two years after last patient enrolled.
Safety Profile of Revlimid
Time Frame: Two years after last patient enrolled
All Adverse Events (AEs) and occurrence of second primary malignancies (SPM)
Two years after last patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Yu (Flora) Yao, MD, Celgene Pharmaceutical (Shanghai) Co. Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPMS-RV-CN-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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