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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01947309
• Other study ID #: NIPMS-RV-CN-001
• Status: Terminated
• Phase: N/A
• First received: September 18, 2013
• Last updated: January 10, 2017
• Start date: November 2013
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Terminated
• Enrollment: 176
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Revlimid (lenalidomide)
Revlimid (lenalidomide) as prescribed in usual clinical practice

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing
China	Peking Chao-Yang Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	People's Liberation Army Hospital 307	Beijing
China	The Fisrt Hospital Of Jilin University	Changchun
China	Xiangya Hospital Central-South University	Changsha
China	Xinqiao Hospital, 3rd Military Medical University	Chongqing
China	NanFang Hospital of China Southern Medical University	Guangzhou
China	The First Affliated Hospital of Anhui Medical University	Hefei
China	Qilu Hospital of Shandong University	Jinan
China	The Affiliated Hospital of Mecical College Qingdao University	Qingdao
China	Shanghai Changzhen Hospital	Shanghai
China	The Second Affiliated Hospital Of China Medical University	Shenyang
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	Wuhan Union Hospital of Tongji Medical College of Huazhong University of Science & Technology	Wuhan

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	Assessment of PFS using IMWG Uniform Response Criteria	2 years after enrollment of last patient	No
Primary	Response Rates	Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria	2 years after enrollment of last patient	No
Secondary	Overall Survival (OS)		Two years after last patient enrolled	No
Secondary	Time to Response (TTR) and Duration of Response (DOR)		Two years after last patient enrolled	No
Secondary	Duration of Treatment with Revlimid	Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID	Two years after last patient enrolled.	Yes
Secondary	Safety Profile of Revlimid	All Adverse Events (AEs) and occurrence of second primary malignancies (SPM)	Two years after last patient enrolled	Yes