NCT03660072

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
3.4 years until next milestone

Study Start

First participant enrolled

January 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

August 20, 2018

Last Update Submit

May 24, 2022

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Incidence of AE's and SAE's

    24 Months

Secondary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

Non-InterventionalOTHER

Non-Interventional

Empliciti combination therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean participants with Multiple Myeloma

You may qualify if:

  • Adult participants who have a confirmed diagnosis of Multiple Myeloma (MM)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Seoul, 05510, South Korea

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

September 6, 2018

Study Start

January 31, 2022

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

KR(1)