Multiple Myeloma, Multiple Myeloma Progression, Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Plasma Cell Disorders
Conditions
Keywords
multiple myeloma, hematology, plasma cell disorders
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.
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.
Interventions
Screening blood sample collection to test for MGUS
Sponsors
Wake Forest University Health Sciences
Atrium Health Levine Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
SCREENING 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who were Enrolled | Baseline, for an accrual period of one year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monoclonal Gammopathy at Screening | From enrollment to availability of lab results, approximately 30 days | 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 | From enrollment to completion of diagnostic work up, approximately 90 days | 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 | From enrollment to completion of follow up (10 years) | 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 | From enrollment to completion of follow up (10 years) | 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 |
| Time to MM Diagnosis | From enrollment to completion of follow up (10 years) | Time to MM diagnosis is defined as the duration of time from MGUS diagnosis (or SMM diagnosis for participants diagnosed with SMM at screening) to diagnosis of MM per IMWG criteria. The date of MM diagnosis is the date of the first assessment that identified MM. If the participant died without a diagnosis of MM, time to MM diagnosis will be calculated at the date of death, with death as a competing risk event. For surviving subjects who do not have documented MM diagnosis, time to MM diagnosis will be censored at the date of the last documented disease evaluation that confirmed no MM diagnosis. |
| Number of Participants who Interacted with a Community Champion | Baseline | Interaction with a community champion will be captured for each potential participant as a binary variable indicating whether or not the potential participant interacted with a study-associated community champion prior to enrollment or prior to declining participation. This will be captured via the "Interaction with Community Champion Survey". |
| Impact of Interaction with a Community Champion | Baseline | Community champion impact will be reported by each enrolled participant that interacted with a community champion. It will be captured as an ordered categorical variable (5-point Likert scale) indicating the level of impact that the community champion had on the participant's decision to participate in the study. This will be captured via the "Interaction with Community Champion Survey". |
| Number of MGUS Participants who Participate in Longitudinal Portion of Study | From enrollment to presentation of second (longitudinal) consent, approximately 90 days | For each participant that is determined to have MGUS at screening, a binary variable will be captured, indicating whether or not the participant consented to be followed longitudinally in the longitudinal portion of the study. |
| Barriers to Screening Participation | Baseline | For participants who are approached but do not verbally agree to participation in the study, verbal reason for declining study participation will be reported and captured via a "Barriers to Participation Survey" that includes multi-select discrete options as well as an "Other" reason with free text option. |
| Barriers to Longitudinal Participation | From enrollment to presentation of second (longitudinal) consent, approximately 90 days | For participants with monoclonal gammopathy identified during screening but who do not agree to participate in the longitudinal portion of the study, reason for declining longitudinal participation will be reported and captured via a "Barriers to Participation Survey" that includes multi-select discrete options as well as an "Other" with free text option. |
| Psychological Counseling Referral | From enrollment to completion of diagnostic work up, approximately 90 days. | For each participant with monoclonal gammopathy identified during screening, a binary variable indicating whether a psychological counseling referral was accepted after learning of positive results. |
| Light Chain MGUS Diagnosis at Screening | From enrollment to completion of diagnostic work up, approximately 90 days. | Determined as a binary variable indicating whether the participant had light chain MGUS diagnosis at screening. Three definitions of light chain MGUS (with applicable reference ranges for FLC ratio, involved FLC) will be utilized to evaluate this endpoint: standard IMWG diagnostic criteria \[with FLC ranges from Katzmann et al (2002)\], iStop MM criteria incorporating age and renal function \[Long et al (2025)\], and Dana Farber Cancer Institute criteria incorporating race \[Bertamini et al (2025)\]. |
Countries
United States
Contacts
CONTACTMargarita Dzhanumova
PRINCIPAL_INVESTIGATORManisha Bhutani, MD
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Outcome results
None listed