- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02921828
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg
June 30, 2022 updated by: Celgene
Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)
- 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.
- Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1149
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hyogo
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Kobe, Hyogo, Japan, 651-0072
- Shinko Hospital
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New Jersey
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No City Provided, New Jersey, United States, 00000
- Local Institution - Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Description
Inclusion Criteria:
- Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Multiple myeloma patients who received Pomalyst
Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event (AE)
Time Frame: 3 years
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Number of participants with adverse events
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jinshu Cho, Celgene
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2015
Primary Completion (Actual)
December 10, 2015
Study Completion (Actual)
December 10, 2015
Study Registration Dates
First Submitted
September 30, 2016
First Submitted That Met QC Criteria
September 30, 2016
First Posted (Estimate)
October 3, 2016
Study Record Updates
Last Update Posted (Actual)
July 5, 2022
Last Update Submitted That Met QC Criteria
June 30, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Keywords
- confusion
- hypersensitivity
- fatigue
- thromboembolism
- peripheral neuropathy
- infection
- heart failure
- bone marrow suppression
- dizziness
- arrhythmia
- jaundice
- acute renal failure
- Pomalyst
- interstitial pneumonia
- somnolence
- Teratogenicity
- tumour lysis syndrome
- depressed level of consciousness
- hepatic function disorder
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Multiple Myeloma
Other Study ID Numbers
- NIS-Celgene-JP-PMS-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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