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

NCT ID: NCT05831358

Last Updated: 2025-08-17

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2026-07-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance Smoldering Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Not a randomized trial; use of convenience sampling.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Multiple Myeloma Screening Experience

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.

Group Type EXPERIMENTAL

Multiple Myeloma M-Protein Analysis

Intervention Type OTHER

Participants will be screened with a blood test for monoclonal protein analysis

Multiple Myeloma Knowledge Questionnaires

Intervention Type OTHER

Participants will complete two questionnaires to share their attitudes toward their screening experience and completion of knowledge questions to gauge community reception and participant multiple myeloma knowledge.

Interventions

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Multiple Myeloma M-Protein Analysis

Participants will be screened with a blood test for monoclonal protein analysis

Intervention Type OTHER

Multiple Myeloma Knowledge Questionnaires

Participants will complete two questionnaires to share their attitudes toward their screening experience and completion of knowledge questions to gauge community reception and participant multiple myeloma knowledge.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Valent, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CASE1A23

Identifier Type: -

Identifier Source: org_study_id

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