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Trial Title:
Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program
NCT ID:
NCT05831358
Condition:
Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Myeloma Proteins
Paraproteins
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Not a randomized trial; use of convenience sampling.
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Multiple Myeloma M-Protein Analysis
Description:
Participants will be screened with a blood test for monoclonal protein analysis
Arm group label:
Multiple Myeloma Screening Experience
Intervention type:
Other
Intervention name:
Multiple Myeloma Knowledge Questionnaires
Description:
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.
Arm group label:
Multiple Myeloma Screening Experience
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jason Valent, MD
Investigator:
Last name:
Jason Valent, MD
Email:
Principal Investigator
Start date:
June 16, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Case Comprehensive Cancer Center
Agency class:
Other
Source:
Case Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05831358
