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NCT02921802 Clinical Trial

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

Multiple Myeloma Clinical Trial

Official title:
Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02921802
Other study ID # NIS-Celgene-JP-PMS-001a
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2010
Est. completion date March 29, 2013

Study information
Verified date June 2022
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 4626
Est. completion date March 29, 2013
Est. primary completion date March 29, 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Shinko Hospital Kobe Hyogo

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events (AEs) Number of participants with adverse events for 6 month treatment Up to 6 months
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