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

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

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Monoclonal Gammopathy of Undetermined Significance (MGUS) Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Monoclonal Gammopathy of Undetermined Significance Non-IgM Monoclonal Gammopathy of Undetermined Significance Paraproteinemias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Pilot Study of 13Carbon-Based Deep Labeling of Bone Marrow Cells to Map Their Utilization of Extracellular Metabolites

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jul 10, 2025
Registry last updated: Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting