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Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03660072
Enrollment
0
Registered
2018-09-06
Start date
2022-01-31
Completion date
2022-10-28
Last updated
2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Brief summary

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

Interventions

OTHERNon-Interventional

Non-Interventional

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Incidence of AE's and SAE's24 Months

Secondary

MeasureTime frame
Overall response of Empliciti treatment with lenalidomide and dexamethasone24 Months
Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone24 Months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026