A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
Completed
- Conditions
- Multiple MyelomaMyelodysplastic Syndromes
- Registration Number
- NCT02921802
- Lead Sponsor
- Celgene
- Brief Summary
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.
1. 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.
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4626
Inclusion Criteria
- 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.
Exclusion Criteria
N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) Up to 6 months Number of participants with adverse events for 6 month treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shinko Hospital
🇯🇵Kobe, Hyogo, Japan