Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program

Not Applicable

Active, not recruiting

• Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma
• Interventions: Other: Multiple Myeloma M-Protein Analysis; Other: Multiple Myeloma Knowledge Questionnaires

• Registration Number: NCT05831358
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

This project will pilot the expansion of the existing Taussig Outreach Program's community outreach and patient navigation model to study the multiple myeloma (MM) screening program. This involves analyzing community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This study also aims to gauge the current and general understanding of MM. This study seeks to recruit participants in the pilot screening program to promote early detection. Participants who have abnormal results will receive patient navigation for further diagnostics and testing.

Detailed Description

Multiple Myeloma (MM) is a hematologic cancer of antibody-producing plasma cells. Multiple Myeloma is always preceded by a pre-malignant condition called monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma. Despite multiple therapeutic advances, there remains no cure for multiple myeloma. The disease is treated and monitored throughout a person's lifetime. This is why screening for early detection of this disease is important; however, MGUS and smoldering multiple myeloma are only diagnosed when they are found incidentally on labs during tests for unrelated symptoms. There are no current universal screening guidelines for MM. Among those who may benefit from MM screenings include African American/Black individuals, as it is twice as common in this population compared to Caucasian/White individuals. This study aims to develop a screening program specifically targeting underserved African American/Black individuals. This project will expand the existing Taussig Community Outreach screening program to include screening for multiple myeloma.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-26
• Study Start: 2023-06-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

• Participant self-identifying as, or perceived as, Black and/or African-American
• 50 years of age or older

Exclusion Criteria

• Participants who do not self-identify as Black and/or African American
• Under the age of 50 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma Screening Experience	Multiple Myeloma Knowledge Questionnaires	Participants will partake in a multiple myeloma screening program. The screening involves a blood sample and the completion of a questionnaire to gauge participants' multiple myeloma knowledge.
Multiple Myeloma Screening Experience	Multiple Myeloma M-Protein Analysis	Participants will partake in a multiple myeloma screening program. The screening involves a blood sample and the completion of a questionnaire to gauge participants' multiple myeloma knowledge.

Primary Outcome Measures

Name	Time	Method
To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM	12 months	The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by participant questionnaires detailing their attitudes toward, and experience, of the screening.
To study participant knowledge of Multiple Myeloma	12 months	Participants will gain knowledge about Multiple Myeloma from the time of the screening to the time of follow-up one week or more after the screening. This will be measured by examining the difference in participant post-screening questionnaire results.

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States