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NCT06644625 | NOT YET RECRUITING | Multiple Myeloma

CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study
Sponsor:

Wake Forest University Health Sciences

Brief 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.

Condition or disease

Multiple Myeloma

Multiple Myeloma Progression

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Smoldering Multiple Myeloma (SMM)

Plasma Cell Disorders

Intervention/treatment

Blood draw for the laboratory assessment

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. 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 1665 participants
Official Title : CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2035-01
Estimated Study Completion Date : 2035-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 30 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study

Location Details

NCT06644625

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, North Carolina

Atrium Health Levine Cancer

Charlotte, North Carolina, United States, 28204