Postmarketing Study of Empliciti in Korean Patients With Multiple Myeloma

May 24, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Korean participants with Multiple Myeloma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of AE's and SAE's
Time Frame: 24 Months
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response of Empliciti treatment with lenalidomide and dexamethasone
Time Frame: 24 Months
24 Months
Incidence of infusion-related reactions associated with Empliciti treatment in combination with lenalidomide and dexamethasone
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 31, 2022

Primary Completion (ANTICIPATED)

October 28, 2022

Study Completion (ANTICIPATED)

October 28, 2022

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (ACTUAL)

September 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA204-176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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