CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study

Wake Forest University (WFU)

Status

Suspended

Conditions

Plasma Cell Disorders

Multiple Myeloma

Multiple Myeloma Progression

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Smoldering Multiple Myeloma (SMM)

Treatments

Other: Blood draw for the laboratory assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06644625

IRB00107462

LCI-PCD-MGUS-SCRN-001 (Other Identifier)

Details and patient eligibility

About

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.

Full 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. Black and/or African American adults 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.

Enrollment

1,665 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

SCREENING Inclusion Criteria:

Self-identify as Black and/or African American
Age 30 years or older at the time of consent
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

SCREENING Exclusion Criteria:

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

LONGITUDINAL Inclusion Criteria:

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

LONGITUDINAL Exclusion Criteria:

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.