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
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|ClinicalTrials.gov Identifier: NCT02921828|
Recruitment Status : Active, not recruiting
First Posted : October 3, 2016
Last Update Posted : June 4, 2019
- 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.
- Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1149 participants|
|Official Title:||Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)|
|Actual Study Start Date :||May 21, 2015|
|Estimated Primary Completion Date :||May 20, 2025|
|Estimated Study Completion Date :||May 20, 2025|
Multiple myeloma patients who received 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 ]Number of participants with adverse events
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): NCT02921828
|Kobe, Hyogo, Japan, 651-0072|
|Study Director:||Jinshu Cho||Celgene|