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.
Age 30 years or older at the time of consent
Self-identify as Black and/or African American OR
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
Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.
Test positive for monoclonal gammopathy during screening portion of the study
Consent to the longitudinal portion of the study
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.
High risk individuals with age greater than or equal to 30 years at the time of consent, residing in the Charlotte, NC or surrounding areas.
Cohort
Prospective
Blood draw for the laboratory assessment
Other interventionScreening blood sample collection to test for MGUS
Number of Participants who were Enrolled
Determined for each potential participant approached to participate in this study (pre-screened), indicating whether or not the participant was enrolled (underwent blood draw to test for monoclonal gammopathy).
Monoclonal Gammopathy at Screening
A categorical variable will be determined for each enrolled participant indicating whether or not the participant had monoclonal gammopathy identified on screening blood draw, or if the test results were indeterminate (options: monoclonal gammopathy, no monoclonal gammopathy, unknown/indeterminant test results).
PCD Diagnosis at Screening
PCD diagnosis at screening will be determined as a nominal categorical variable indicating the participant's PCD diagnosis at screening. The categorical variable will include the following factor levels: monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), multiple myeloma (MM), AL amyloidosis, other PCD/ lymphoproliferative disorder, monoclonal gammopathy with unknown diagnosis, or no monoclonal gammopathy. Reason for unknown diagnosis may be due to non-definitive results, no results due to lab error, sampling issues, or participant did not get complete diagnostic work up.
PCD Diagnosis During Follow-Up
PCD diagnosis during follow-up will be determined as a categorical variable for each new PCD diagnosis indicating whether the participant had the type of PCD diagnosed over the course of the follow up period on the study. The types of new PCD diagnosis will include SMM, MM, AL amyloidosis, and other PCD diagnosis, per diagnostic criteria as defined in Appendix A. Date of each new PCD diagnosis will also be captured.
CRAB Criteria at MM Diagnosis
CRAB criteria at MM diagnosis are defined as a binary variable indicating whether the participant had CRAB criteria at the time of MM diagnosis. CRAB criteria include hypercalcemia, renal insufficiency, anemia, or bone lesions as defined per IMWG. This will be evaluated only in the subjects diagnosed with MM during longitudinal follow-up
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
