Revlimid® Capsules Special Drug Use-results Survey (in Patients With Newly-diagnosed Multiple Myeloma [NDMM])
Completed
- Conditions
- Multiple Myeloma
- Registration Number
- NCT02741544
- Lead Sponsor
- Celgene
- Brief Summary
To understand the safety and efficacy of Revlimid® 2.5mg and 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
- 578
Inclusion Criteria
- Newly-diagnosed multiple myeloma who are treated with Revlimid Capsules
Exclusion Criteria
- N/A
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events (AEs) Up to approximately 6 months Number of participants with adverse events
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shinko Hospital
🇯🇵Kobe, Hyogo, Japan