CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
Purpose
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.
Conditions
- Multiple Myeloma
- Multiple Myeloma Progression
- Monoclonal Gammopathy of Undetermined Significance (MGUS)
- Smoldering Multiple Myeloma (SMM)
- Plasma Cell Disorders
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| MGUS and Smoldering Multiple Myeloma | Participants diagnosed with MGUS and smoldering multiple myeloma |
|
| Other Plasma Cell Disorders | Participants diagnosed with other plasma cell disorders |
|
Recruiting Locations
Charlotte, North Carolina 28204
More Details
- Status
- Recruiting
- Sponsor
- Wake Forest University Health Sciences
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.