- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660072
Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
May 24, 2022 updated by: Bristol-Myers Squibb
Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
Study Overview
Study Type
Observational
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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Seoul, Korea, Republic of, 05510
- Local Institution
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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
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Korean participants with Multiple Myeloma
Description
Inclusion Criteria:
- Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)
Exclusion Criteria:
- Participants who use Empliciti for therapeutic indications which are not approved for Empliciti combination therapy in Korea
- Patients in whom treatment with Empliciti (as clarified in the Korean label) is contraindicated
Other protocol defined inclusion/exclusion criteria could apply
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 |
Intervention / Treatment |
---|---|
Empliciti combination therapy
Adult patients with a confirmed diagnosis of MM who have received, are currently receiving, or will begin Empliciti combination therapy
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Non-Interventional
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of AE's and SAE's
Time Frame: 24 Months
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24 Months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall response of Empliciti treatment with lenalidomide and dexamethasone
Time Frame: 24 Months
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24 Months
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Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone
Time Frame: 24 Months
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24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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 (ANTICIPATED)
January 31, 2022
Primary Completion (ANTICIPATED)
October 28, 2022
Study Completion (ANTICIPATED)
October 28, 2022
Study Registration Dates
First Submitted
August 20, 2018
First Submitted That Met QC Criteria
September 4, 2018
First Posted (ACTUAL)
September 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 24, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
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
- Multiple Myeloma
- Neoplasms, Plasma Cell
Other Study ID Numbers
- CA204-176
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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