CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study

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

RECRUITING

Total Enrollment

1665 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2035-01-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MGUS and Smoldering Multiple Myeloma

Participants diagnosed with MGUS and smoldering multiple myeloma

Blood draw for the laboratory assessment

Intervention Type OTHER

Screening blood sample collection to test for MGUS

Other Plasma Cell Disorders

Participants diagnosed with other plasma cell disorders

Blood draw for the laboratory assessment

Intervention Type OTHER

Screening blood sample collection to test for MGUS

Interventions

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Blood draw for the laboratory assessment

Screening blood sample collection to test for MGUS

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 30 years or older at the time of consent
* Either:

1. Self-identify as Black and/or African American OR
2. First-degree relatives (parents, siblings, or children) of patients of any race or ethnicity diagnosed with a plasma cell disorder, including MGUS, smoldering multiple myeloma (SMM), multiple myeloma (MM), solitary plasmacytoma, plasma cell leukemia, AL amyloidosis, POEMS syndrome, and Waldenström's Macroglobulinemia
* Capable and willing to provide informed consent. NOTE: HIPAA (Health Insurance Portability and Accountability Act) authorization for the release of personal health information may be included in the informed consent or obtained separately
* Reside in Charlotte, NC, or the surrounding area, based on self-report

* Test positive for monoclonal gammopathy during screening portion of the study
* Consent to the longitudinal portion of the study

Exclusion Criteria

* Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.

* The participant previously underwent diagnostic work up as part of CHAAMP Internal Pilot that did not result in a diagnosis of MGUS, Smoldering Multiple Myeloma or other non-plasma cell disorder.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes