A Study of Special Use Results Surveillance of Revlimid 5mg Capsules

Celgene

Status: Completed

Conditions: Multiple Myeloma; Myelodysplastic Syndromes

Study type: Observational

Funder types: Industry

Identifiers

NCT02921802

NIS-Celgene-JP-PMS-001a

Details and patient eligibility

About

To understand the safety and efficacy of Revlimid® 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.

Enrollment: 4,626 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

Exclusion criteria

N/A

Trial design

4,626 participants in 1 patient group

Patients who received Revlimid

Description:

Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.