Overview

This trial is active, not recruiting.

Condition multiple myeloma
Sponsor Celgene Corporation
Start date May 2015
End date May 2025
Trial size 1121 participants
Trial identifier NCT02921828, NIS-Celgene-JP-PMS-002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Primary Outcomes

Measure
Adverse event (AE)
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. Exclusion Criteria:

Additional Information

Official title Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.