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NCT02922543 Clinical Trial

A Safety and Efficacy Study of Revlimid® 5 mg Capsules in Patients With Relapsed or Refractory Multiple Myeloma Who Have Received Long-term Treatment With it Under the Actual Condition of Use

Multiple Myeloma Clinical Trial

Official title:
Revlimid 5 mg Capsules Special Use-results Surveillance of Long Term Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02922543
Other study ID # NIS-Celgene-JP-PMS-001b
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 18, 2011
Est. completion date October 11, 2014

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 patients with "relapsed or refractory multiple myeloma" (hereinafter referred to as "relapsed or refractory MM") who have received long-term treatment with it under the actual condition of use. 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, 300, is reached (estimated to be approximately 1 year and 3 moths). 2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid (estimated to be approximately 4 years and 3 months).

Recruitment information / eligibility
Status Completed
Enrollment 361
Est. completion date October 11, 2014
Est. primary completion date October 11, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Relapsed or refractory MM patients in the special use-results surveillance (all-case surveillance) (hereinafter referred to as the all-case surveillance) who have received Revlimid treatment for at least 7 cycles at institutions cooperating in performing the all-case surveillance and 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 3 years
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