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

N/ATerminatedNCT01947309

Celgene176 enrolled

Overview

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).

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

176

Conditions

Multiple Myeloma

Interventions

Revlimid (lenalidomide)DRUG

Revlimid (lenalidomide) as prescribed in usual clinical practice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (17)

Peking Chao-Yang Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Assessment of PFS using IMWG Uniform Response Criteria

Time frame: 2 years after enrollment of last patient

Response Rates

Assessment of Response Rates (CR, VGPR, PR) using IMWG Uniform Response Criteria

Time frame: 2 years after enrollment of last patient

Secondary Outcomes

Overall Survival (OS)

Time frame: Two years after last patient enrolled

Time to Response (TTR) and Duration of Response (DOR)

Time frame: Two years after last patient enrolled

Duration of Treatment with Revlimid

Reason for dose interruption/reduction of REVLIMID, if this occurs. Reason for discontinuation of REVLMID

Time frame: Two years after last patient enrolled.

Safety Profile of Revlimid

All Adverse Events (AEs) and occurrence of second primary malignancies (SPM)

Time frame: Two years after last patient enrolled

Data from ClinicalTrials.gov

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