CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study

NCT06644625 | Recruiting DMC

• 3 other identifiers: IRB00107462LCI-PCD-MGUS-SCRN-001NCI-2025-00147
• Study Type: observational
• Target: 1,665
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Multiple Myeloma Progression; Smoldering Multiple Myeloma (SMM); Plasma Cell Disorders; Monoclonal Gammopathy of Undetermined Significance (MGUS)

Keywords

multiple myeloma; hematology; plasma cell disorders

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Monoclonal Gammopathy at Screening

  From enrollment to availability of lab results, approximately 30 days

• PCD Diagnosis at Screening

  From enrollment to completion of diagnostic work up, approximately 90 days

• PCD Diagnosis During Follow-Up

  From enrollment to completion of follow up (10 years)

• CRAB Criteria at MM Diagnosis

  From enrollment to completion of follow up (10 years)

• Time to MM Diagnosis

  From enrollment to completion of follow up (10 years)

Study Arms (2)

MGUS and Smoldering Multiple Myeloma

Participants diagnosed with MGUS and smoldering multiple myeloma

Other: Blood draw for the laboratory assessment

Other Plasma Cell Disorders

Participants diagnosed with other plasma cell disorders

Other: Blood draw for the laboratory assessment

Interventions

Blood draw for the laboratory assessment OTHER

Screening blood sample collection to test for MGUS

MGUS and Smoldering Multiple Myeloma; Other Plasma Cell Disorders

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Atrium Health Levine Cancer Institute: collaborator

Study Sites (1)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and buccal swab

MeSH Terms

Conditions

Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Hypergammaglobulinemia; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Manisha Bhutani, MD

  Atrium Health Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margarita Dzhanumova

CONTACT

704-754-3768; margarita.dzhanumova@atriumhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 16, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)