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

August 15, 2025 updated by: Case Comprehensive Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

201

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Multiple Myeloma M-Protein Analysis
Participants will be screened with a blood test for monoclonal protein analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To study participant knowledge of Multiple Myeloma
Time Frame: 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.
12 months
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
Time Frame: 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 the overall community reception of this screening being offered.
12 months
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
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Jason Valent, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE1A23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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