A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan

Study Overview
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Brief Summary
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The REVLIMID Registry will provide safety data from a large cohort of Taiwanese patients treated with REVLIMID. In addition, the registry will provide efficacy data and outcomes in a real-world setting (versus a clinical trial).

Detailed Description
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The REVLIMID Registry is a prospective, multi-center, observational study. The registry will register 100 patients being prescribed REVLIMID in Taiwan during and patients will be followed for two years after the enrollment of the last patient. Safety and efficacy data will be recorded in the registry monthly or bi-monthly. In accordance with the Risk Minimization Program for REVLIMID (RevAssure) a patient categorized as a woman of childbearing potential will be prescribed REVLIMID on a monthly basis, whereas women of non-childbearing potential and men will be allowed up to two months supply per prescription. After entry of baseline data, the prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI)

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: Revlimid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients 18 years of age or older Patients that are being prescribed REVLIMID in combination with dexamethasone for the treatment of multiple myeloma and that have received at least one prior therapy Patient must be willing and able to provide informed consent Patients will be informed about the Registry and will have to sign a specific Registry Informed Consent Form Be able to ask questions prior to signing the Subject Information and Consent Form Be clearly informed that their involvement/participation in the registry is voluntary Understand that their medical care will not be altered in any way by their participation in the registry Exclusion Criteria: - A Patient who is unwilling or unable to provide informed consent will not be included.

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 |
| --- | --- |
| REVLIMID<br>Taiwanese patients treated with REVLIMID | Drug: Revlimid<br>* The prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI).<br>* Other names: CC-5013;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with adverse events | Up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Revlimid dosage, reason for Revlimid discontinuation | Up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple myeloma