Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
Withdrawn
- Conditions
- Multiple Myeloma
- Interventions
- Other: Non-Interventional
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Empliciti combination therapy Non-Interventional Adult patients with a confirmed diagnosis of MM who have received, are currently receiving, or will begin Empliciti combination therapy
- 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