Clinical trial · Observational
CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study
NCT06644625CI-TRIAL-00117799recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy of Undetermined Significance (MGUS) | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Multiple Myeloma Progression | — | UNRESOLVED | — |
| Plasma Cell Disorders | — | UNRESOLVED | — |
| Smoldering Multiple Myeloma (SMM) | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw for the laboratory assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- MGUS and Smoldering Multiple Myeloma
- description
- Participants diagnosed with MGUS and smoldering multiple myeloma
- interventionNames
- Other: Blood draw for the laboratory assessment
- label
- Other Plasma Cell Disorders
- description
- Participants diagnosed with other plasma cell disorders
- interventionNames
- Other: Blood draw for the laboratory assessment
Primary outcomes (1)
- measure
- Number of Participants who were Enrolled
- timeFrame
- Baseline, for an accrual period of one year
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.