Clinical trial · Observational
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
Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Multiple myeloma patients who received Pomalyst
- description
- Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Primary outcomes (1)
- measure
- Adverse event (AE)
- timeFrame
- 3 years
- description
- Number of participants with adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. Exclusion Criteria: * N/A
References
Publications (0)
Data not yet available