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| ID | Type | Description | Link |
|---|---|---|---|
| LCI-PCD-MGUS-SCRN-001 | Other Identifier | Atrium Health Wake Forest Baptist Comprehensive Cancer Center | |
| NCI-2025-00147 | Other Identifier | National Cancer Institute |
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| Name | Class |
|---|---|
| Atrium Health Levine Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGUS and Smoldering Multiple Myeloma | Participants diagnosed with MGUS and smoldering multiple myeloma |
| |
| Other Plasma Cell Disorders | Participants diagnosed with other plasma cell disorders |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draw for the laboratory assessment | Other | Screening blood sample collection to test for MGUS |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, for an accrual period of one year |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to availability of lab results, approximately 30 days |
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SCREENING Inclusion Criteria:
Age 30 years or older at the time of consent
Either:
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:
LONGITUDINAL Inclusion Criteria:
LONGITUDINAL Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margarita Dzhanumova | Contact | 704-754-3768 | margarita.dzhanumova@atriumhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Manisha Bhutani, MD | Atrium Health Wake Forest Baptist Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Levine Cancer | Recruiting | Charlotte | North Carolina | 28204 | United States |
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Blood and buccal swab
| 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. | From enrollment to completion of diagnostic work up, approximately 90 days |
| 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. | From enrollment to completion of follow up (10 years) |
| 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 | From enrollment to completion of follow up (10 years) |
| Time to MM Diagnosis | 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. | From enrollment to completion of follow up (10 years) |
| Number of Participants who Interacted with a Community Champion | 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". | Baseline |
| Impact of Interaction with a Community Champion | 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". | Baseline |
| Number of MGUS Participants who Participate in Longitudinal Portion of Study | 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. | From enrollment to presentation of second (longitudinal) consent, approximately 90 days |
| Barriers to Screening Participation | 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. | Baseline |
| Barriers to Longitudinal Participation | 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. | From enrollment to presentation of second (longitudinal) consent, approximately 90 days |
| Psychological Counseling Referral | 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. | From enrollment to completion of diagnostic work up, approximately 90 days. |
| Light Chain MGUS Diagnosis at Screening | 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)]. | From enrollment to completion of diagnostic work up, approximately 90 days. |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006942 | Hypergammaglobulinemia |
| D011230 | Precancerous Conditions |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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