CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw for the laboratory assessment.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Multiple Myeloma Progression, Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM). Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other Blood draw for the laboratory assessment
Screening blood sample collection to test for MGUS
Primary outcome measures
- Number of Participants who were Enrolled [Time frame: Baseline, for an accrual period of one year]
Secondary outcome measures (12)
- Monoclonal Gammopathy at Screening [Time frame: From enrollment to availability of lab results, approximately 30 days]
- PCD Diagnosis at Screening [Time frame: From enrollment to completion of diagnostic work up, approximately 90 days]
- PCD Diagnosis During Follow-Up [Time frame: From enrollment to completion of follow up (10 years)]
- CRAB Criteria at MM Diagnosis [Time frame: From enrollment to completion of follow up (10 years)]
- Time to MM Diagnosis [Time frame: From enrollment to completion of follow up (10 years)]
- Number of Participants who Interacted with a Community Champion [Time frame: Baseline]
- Impact of Interaction with a Community Champion [Time frame: Baseline]
- Number of MGUS Participants who Participate in Longitudinal Portion of Study [Time frame: From enrollment to presentation of second (longitudinal) consent, approximately 90 days]
- Barriers to Screening Participation [Time frame: Baseline]
- Barriers to Longitudinal Participation [Time frame: From enrollment to presentation of second (longitudinal) consent, approximately 90 days]
- Psychological Counseling Referral [Time frame: From enrollment to completion of diagnostic work up, approximately 90 days.]
- Light Chain MGUS Diagnosis at Screening [Time frame: From enrollment to completion of diagnostic work up, approximately 90 days.]
Eligibility criteria
SCREENING Inclusion Criteria:
- Age 30 years or older at the time of consent
- Either:
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Atrium Health Levine Cancer — Charlotte
Identifiers
NCT: NCT06644625 · IRB00107462 · LCI-PCD-MGUS-SCRN-001 · NCI-2025-00147