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

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Mayo Clinic

Status

Invitation-only

Conditions

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

Treatments

Other: Non-Interventional Study

Study type

Observational

Funder types

Other

Identifiers

NCT07057583
HT9425-24-1-0619 (Other Grant/Funding Number)
NCI-2025-01095 (Registry Identifier)
24-003478 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Observational Group I
Description:
Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.
Treatment:
Other: Non-Interventional Study
Observational Group II
Description:
Healthy volunteers undergo blood collection and bone marrow aspiration on study.
Treatment:
Other: Non-Interventional Study

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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