Charlotte African American MGUS project (CHAAMP): A prospective pilot study of MGUS screening in black and/or African American adults

Abstract

Abstract Background Among Black and/or African American individuals, multiple myeloma (MM) is the most common hematologic malignancy, occurring at twice the rate seen in White individuals, often with earlier onset, more advanced disease, and poorer outcomes due to delayed diagnoses and limited access to care.MM is consistently preceded by monoclonal gammopathy of undetermined significance (MGUS), a precursor condition that is three times more prevalent in the Black and/or African American population. While early detection of MM through MGUS screening and monitoring may improve outcomes, its benefits have not been adequately studied in Black and/or African American populations. We hypothesize that early identification of MM at the MGUS stage, with appropriate monitoring, can reduce diagnostic delays, lower morbidity, and improve outcomes. Studying a large cohort over time will help uncover population-specific features toinform preventive strategies to halt the progression of MGUS to MM and guide optimal treatment approaches for affected individuals. To address this need, the Levine Cancer Institute has launched the pilot phase of the Charlotte African American MGUS Project (CHAAMP), a prospective MGUS screening study aimed at improving MM outcomes in Black and/or African American communities in Charlotte, NC and surrounding areas. Objectives The primary objective is to assess the feasibility of enrolling participants for a larger screening study. Secondary objectives include refining assumptions (e.g., MGUS prevalence, participation rates), evaluating acceptability of study procedures, assessing impact of community champions on recruitment, studying natural history of MGUS and smoldering multiple myeloma (SMM), and gauging acceptance of psychological counseling referrals. Study Design and Methods Eligible participants must self-identify as Black and/or African American, be 30 years or older, and reside in Charlotte or surrounding areas. Over the course of one year, participants who provide initial consent will undergo screening for monoclonal gammopathy using a one-time blood test (serum protein electrophoresis/immunofixation and serum free light chain assay). Enrollment rates will be compared to pre-specified targets, with no formal hypothesis testing. The goal is to enroll 1,665 participants during the pilot phase, with enrollment rate monitoring serving as a key focus. Participants who screen positive will be referred for further evaluation to confirm MGUS, SMM, or other plasma cell disorders (PCDs), with the option to consent to longitudinal follow-up. Those diagnosed with MGUS or SMM will be followed for 10 years, with prospective biobanking of research samples at designated time points. Participants diagnosed with other PCDs will be monitored for survival. If the pilot confirms feasibility, additional participants will be enrolled to reach a total of 10,000 screened in the main study over 4 years, with 10-year follow-up for those testing positive for MGUS or SMM. Recruitment is being conducted through community and healthcare networks, social media, using a combination of in-person outreach and remote communication. IRB-approved messages inform participants and direct them to research coordinators. Community champions with strong local ties encourage participation. To date, the team has made meaningful progress in building community trust. Connections have been established with key stakeholders, including leaders at Atrium Health, local church pastors, and the Charlotte Medical, Dental & Pharmaceutical Society. Community engagement efforts have included participation in food festivals, local professional sporting events, malls, and other public events. Ongoing efforts will focus on strengthening relationships with clinics across Charlotte and surrounding areas, while continuing to host educational and screening events in partnership with local churches. This trial is currently enrolling participants and registered at ClinicalTrials.gov: NCT06644625.