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

• Conditions: Monoclonal Gammopathy of Undetermined Significance
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06472830
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2024-05-22
• Study First Submitted: 2024-06-19
• Study First Submitted QC: 2024-06-19
• Study First Posted: 2024-06-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional 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.

Primary Outcome Measures

Name	Time	Method
Prevalence of MGUS in people of east African descent	Up to 10 years	Screening for MGUS using mass spectrometry to detect monoclonal proteins among people of east African descent in Minnesota.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States