A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
This trial is active, not recruiting.
|Start date||May 2015|
|End date||May 2025|
|Trial size||1121 participants|
|Trial identifier||NCT02921828, NIS-Celgene-JP-PMS-002|
1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst
Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Adverse event (AE)
time frame: 3 years
Male or female participants at least 18 years old.
- Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
|Official title||Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)|
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