NCT06644625

CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,665 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and improve long term outcomes.

Detailed description

The CHAAMP Internal Pilot is a pilot and feasibility study conducted to evaluate the feasibility of the trial methods before a full-scale screening effort is launched. High risk individuals 30 years of age or older residing in Charlotte or surrounding area will be screened for MGUS over one-year period with a target enrollment of 1665 participants. Individuals screening positive for monoclonal gammopathy will be provided a clinic referral for further diagnostic evaluation to confirm MGUS, SMM, or other PCD-related disorder, and will be given the opportunity to consent for the Longitudinal portion of the study. Participants diagnosed with MGUS and smoldering multiple myeloma will be prospectively followed for 10 years per protocol. Participants diagnosed with other plasma cell disorders will have their diagnosis and baseline data captured in the registry and followed for overall survival only.

Conditions

• Multiple Myeloma
• Multiple Myeloma Progression
• Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Smoldering Multiple Myeloma (SMM)
• Plasma Cell Disorders

Interventions

Type	Name	Description
OTHER	Blood draw for the laboratory assessment	Screening blood sample collection to test for MGUS

Timeline

• Start date: 2025-03-01
• Primary completion: 2035-01-01
• Completion: 2035-01-01
• First posted: 2024-10-16
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States