Recruiting

Observational Study

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06644625

Conditions

Multiple Myeloma

Multiple Myeloma Progression

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Smoldering Multiple Myeloma (SMM)

Plasma Cell Disorders

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

Blood draw for the laboratory assessment

Study Details

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

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Smoldering Multiple Myeloma (SMM)

Plasma Cell Disorders

Study ID

NCT06644625

Start date

Mar 1, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2035

Anticipated

Primary completion date

Jan, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

1665 participants

Anticipated

Interventions and Outcome Measures

Arms

MGUS and Smoldering Multiple Myeloma

Participants diagnosed with MGUS and smoldering multiple myeloma

Other Plasma Cell Disorders

Participants diagnosed with other plasma cell disorders

Interventions

Blood draw for the laboratory assessment

Screening blood sample collection to test for MGUS

Primary outcome measure

  • Number of Participants who were Enrolled [ Time Frame: Baseline, for an accrual period of one year ]

Central Contacts and Locations

Central contacts

Locations

Atrium Health Levine Cancer

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Manisha Bhutani, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Keywords

  • multiple myeloma
  • hematology
  • plasma cell disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-13.