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

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

• Registration Number: NCT07057583
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Evaluate differences in the amount of extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs).

OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.

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

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

Study Timeline

• Study Start: 2025-02-01
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)	Up to 30 days	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States