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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07057583

Enrollment

Registered

2025-07-10

Start date

2025-02-01

Completion date

2027-12-31

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERNon-Interventional Study

Non-interventional study

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026