A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
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|ClinicalTrials.gov Identifier: NCT02921802|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : June 5, 2019
To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.
- Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.
- Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.
|Condition or disease|
|Multiple Myeloma Myelodysplastic Syndromes|
|Study Type :||Observational|
|Actual Enrollment :||4626 participants|
|Official Title:||Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)|
|Actual Study Start Date :||July 20, 2010|
|Estimated Primary Completion Date :||June 19, 2020|
|Estimated Study Completion Date :||June 19, 2020|
Patients who received Revlimid
Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.
- Adverse Events (AEs) [ Time Frame: Up to 6 months ]Number of participants with adverse events for 6 month treatment
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): NCT02921802
|Kobe, Hyogo, Japan, 651-0072|
|Study Director:||Jinshu Cho||Celgene|