Prevalence of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Multiple Myeloma (MM) Among Unique Populations of Black People

NCT ID: NCT06472830

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-22

Study Completion Date

2029-05-31

Brief Summary

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This study is being done to screen for monoclonal gammopathies in people of East African descent. Monoclonal gammopathy is a condition where abnormal proteins are found in the blood, most commonly called monoclonal gammopathy of undetermined significance or MGUS. There is little information on the presence of this condition in people of East African descent. This study is being done to determine how this condition affects this population in order to better treat and/or prevent this condition in the future.

Detailed Description

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PRIMARY OBJECTIVE:

I. To determine the prevalence of monoclonal gammopathies (MGUS, Smoldering and Multiple Myeloma) in people of East African descent in Minnesota.

OUTLINE: This is an observational study.

Participants undergo medical chart review and blood sample collection, as well as complete a questionnaire on study. Participants who test positive for MGUS are notified, along with their primary care physician, so that the necessary follow up and referral is provided as clinically indicated.

Conditions

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Monoclonal Gammopathy of Undetermined Significance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Participants undergo medical chart review and blood sample collection, as well as complete a questionnaire on study. Participants who test positive for MGUS are notified, along with their primary care physician, so that the necessary follow up and referral is provided as clinically indicated.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adults ≥ 40 years
* Self-reported east African ancestry (including individuals of mixed east African descent)
* Willing and able to review, understand, and provide consent before starting any study-specific procedures

Exclusion Criteria

* Pregnant women
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joselle M. Cook, M.B.B.S.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2024-04825

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-008956

Identifier Type: OTHER

Identifier Source: secondary_id

23-008956

Identifier Type: -

Identifier Source: org_study_id

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