A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan
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|ClinicalTrials.gov Identifier: NCT01752075|
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : February 13, 2015
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: Revlimid|
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)
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||100 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||A Non-interventional, Observational Post-marketing Registry of Patients Treated With Revlimid (Lenalidomide) in Taiwan|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Taiwanese patients treated with REVLIMID
The prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI).
- Adverse Events [ Time Frame: Up to two years ]Number of participants with adverse events
- Efficacy [ Time Frame: Up to two years ]Revlimid dosage, reason for Revlimid discontinuation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752075
|Study Director:||Ye Hua, MD||Celgene|