Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

Withdrawn

• Conditions: Multiple Myeloma

• Registration Number: NCT03660072
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-06
• Study Start: 2022-01-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-27
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of AE's and SAE's	24 Months

Secondary Outcome Measures

Name	Time	Method
Overall response of Empliciti treatment with lenalidomide and dexamethasone	24 Months
Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone	24 Months

Trial Locations

Locations (1)

Local Institution; 🇰🇷 Seoul, Korea, Republic of