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NCT03660072 Clinical Trial

Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03660072
Other study ID # CA204-176
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 31, 2022
Est. completion date October 28, 2022

Study information
Verified date May 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 28, 2022
Est. primary completion date October 28, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
Korea, Republic of Local Institution Seoul

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of AE's and SAE's 24 Months
Secondary Overall response of Empliciti treatment with lenalidomide and dexamethasone 24 Months
Secondary Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone 24 Months
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