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

Celgene4,626 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

4,626

Conditions

Multiple Myeloma Myelodysplastic Syndromes

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shinko Hospital

Kobe, Hyōgo, Japan

Outcomes

Primary Outcomes

Adverse Events (AEs)

Number of participants with adverse events for 6 month treatment

Time frame: Up to 6 months

Data from ClinicalTrials.gov

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