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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Revlimid (lenalidomide)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multiple Myeloma Patients Treated with Revlimid (lenalidomide)<br>Single Cohort of Multiple Myeloma Patients Treated with Revlimid | Drug: Revlimid (lenalidomide)<br>* Revlimid (lenalidomide) as prescribed in usual clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | Assessment of PFS using IMWG Uniform Response Criteria | 2 years after enrollment of last patient | 
| Response Rates | 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) |  | Two years after last patient enrolled | 
| Time to Response (TTR) and Duration of Response (DOR) |  | 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 | Two years after last patient enrolled. | 
| Safety Profile of Revlimid | All Adverse Events (AEs) and occurrence of second primary malignancies (SPM) | Two years after last patient enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revlimid, lenalidomide, multiple myeloma, PFS, Response Rates