Clinical trial NCT06644625: CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study
Official title: CHAAMP (Charlotte African American MGUS Project) Internal Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Multiple Myeloma Progression
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Smoldering Multiple Myeloma (SMM)
Plasma Cell Disorders
Keywords: multiple myeloma
hematology
plasma cell disorders
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Atrium Health Levine Cancer Institute
First posted: 2024-10-16
Enrollment: 1665
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black and/or African American individuals with age greater than or equal to 30 years at the time of consent, residing in the Charlotte, NC or surrounding areas.

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.

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. Black and/or African American adults 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.

Eligibility criteria: SCREENING Inclusion Criteria:

* Self-identify as Black and/or African American
* Age 30 years or older at the time of consent
* 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.

Primary outcomes:
measure: Number of Participants who were Enrolled
timeFrame: Baseline, for an accrual period of one year
Secondary outcomes:
measure: Monoclonal Gammopathy at Screening
timeFrame: From enrollment to availability of lab results, approximately 30 days
measure: PCD Diagnosis at Screening
timeFrame: From enrollment to completion of diagnostic work up, approximately 90 days
measure: PCD Diagnosis During Follow-Up
timeFrame: From enrollment to completion of follow up (10 years)
measure: CRAB Criteria at MM Diagnosis
timeFrame: From enrollment to completion of follow up (10 years)
measure: Time to MM Diagnosis
timeFrame: From enrollment to completion of follow up (10 years)
measure: Number of Participants who Interacted with a Community Champion
timeFrame: Baseline
measure: Impact of Interaction with a Community Champion
timeFrame: Baseline
measure: Number of MGUS Participants who Participate in Longitudinal Portion of Study
timeFrame: From enrollment to presentation of second (longitudinal) consent, approximately 90 days
measure: Barriers to Screening Participation
timeFrame: Baseline
measure: Barriers to Longitudinal Participation
timeFrame: From enrollment to presentation of second (longitudinal) consent, approximately 90 days
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health Levine Cancer
state: North Carolina
Study officials:
affiliation: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
name: Manisha Bhutani, MD
role: PRINCIPAL_INVESTIGATOR
References: