A Study of Carbon 13-based Deep Labelling of Bone Marrow Cells

NCT07057583 | Enrolling By Invitation

• 3 other identifiers: 24-003478NCI-2025-01095HT9425-24-1-0619
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment.

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS); Non-IgM Monoclonal Gammopathy of Undetermined Significance

Outcome Measures

Primary Outcomes (1)

• Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)

  Assessed by evaluating blood and bone marrow aspirate samples for mean 13Carbon (13C) percentage enrichment of the mass isotopomers of interest of at least 6 (i.e. the difference between a mean 13C percentage enrichment of a particular mass isotopomer is 12% in the MGUS group and 6% in the healthy participant group or vice versa) using a 2-group t-test with a 2-sided significance level of 0.01.

  Up to 30 days

Study Arms (2)

Observational Group I

Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.

Other: Non-Interventional Study

Observational Group II

Healthy volunteers undergo blood collection and bone marrow aspiration on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational Group I; Observational Group II

Eligibility Criteria

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

Study Population

Patients with a diagnosis of monoclonal gammopathy of undetermined significance (MGUS) and healthy volunteers

You may qualify if:

• All Participants:
• At least age 18 years or older
• Able to provide informed consent
• MGUS Cohort:
• International Myeloma Working Group (IMWG) criteria for the diagnosis of non-IgM MGUS

You may not qualify if:

• All Participants:
• Unable to provide consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \>1
• Prior history of adverse events with conscious sedation
• Ongoing use of immunosuppressive medications
• All known pregnant and lactating women will be excluded

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood and bone marrow

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Wilson I. Gonsalves, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 10, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)