CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study

January 15, 2026 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1665

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health Levine Cancer
        • Principal Investigator:
          • Manisha Bhutani, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
MGUS and Smoldering Multiple Myeloma
Participants diagnosed with MGUS and smoldering multiple myeloma
Other: Blood draw for the laboratory assessment
Screening blood sample collection to test for MGUS
Other Plasma Cell Disorders
Participants diagnosed with other plasma cell disorders
Other: Blood draw for the laboratory assessment
Screening blood sample collection to test for MGUS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants who were Enrolled
Time Frame: Baseline, for an accrual period of one year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Monoclonal Gammopathy at Screening
Time Frame: From enrollment to availability of lab results, approximately 30 days
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
PCD Diagnosis at Screening
Time Frame: From enrollment to completion of diagnostic work up, approximately 90 days
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
Time Frame: From enrollment to completion of follow up (10 years)
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
Time Frame: From enrollment to completion of follow up (10 years)
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 Frame: From enrollment to completion of follow up (10 years)
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
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: From enrollment to presentation of second (longitudinal) consent, approximately 90 days
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
Time Frame: Baseline
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
Time Frame: From enrollment to presentation of second (longitudinal) consent, approximately 90 days
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
Time Frame: From enrollment to completion of diagnostic work up, approximately 90 days.
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
Time Frame: From enrollment to completion of diagnostic work up, approximately 90 days.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atrium Health Levine Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Manisha Bhutani, MD, Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00107462
  • LCI-PCD-MGUS-SCRN-001 (Other Identifier: Atrium Health Wake Forest Baptist Comprehensive Cancer Center)
  • NCI-2025-00147 (Other Identifier: National Cancer Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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