Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma
Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT03660072
Collaborator
(none)
0
1
8.9
0
Study Details
Study Description
Brief Summary
This study is a regulatory postmarketing surveillance study for Empliciti with a representative sample of the overall Korean multiple myeloma (MM) population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
0 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Empliciti (Elotuzumab) Postmarketing Surveillance in Korean Patients With Multiple Myeloma
Anticipated Study Start Date
:
Jan 31, 2022
Anticipated Primary Completion Date
:
Oct 28, 2022
Anticipated Study Completion Date
:
Oct 28, 2022
Arms and Interventions
| Arm | 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 |
Other: Non-Interventional
Non-Interventional
|
Outcome Measures
Primary Outcome Measures
- Incidence of AE's and SAE's [24 Months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
and Older
Sexes Eligible for Study:
All
Accepts 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/exclusion criteria could apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Seoul | Korea, Republic of | 05510 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03660072
Other Study ID Numbers:
- CA204-176
First Posted:
Sep 6, 2018
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: