Multiple Myeloma Clinical Trial

Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma

Summary

The utilization of glutamine by the bone marrow plasma cells in MGUS and MM will be compared between each other after infusion of 13-carbon labelled glutamine.

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Full Description

PRIMARY OBJECTIVE:

I. Compare the glutamine anaplerosis activity in bone marrow clonal plasma cells (cPCs) between patients with MGUS and MM using an in vivo and an ex vivo approach.

SECONDARY OBJECTIVES:

I. Compare the tricarboxylic acid (TCA) isotopomer enrichment in the bone marrow plasma obtained from patients with MGUS and MM with the in vivo approach.

II. Determine the peripheral blood enrichment of 13C in the TCA cycle intermediates from patients with MGUS and MM with the in vivo approach.

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP I (EX-VIVO): After an overnight fast of 6 hours, patients undergo collection of blood samples.

GROUP II (IN VIVO): After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose intravenously (IV) over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples.

After completion of study, patient are followed up for 4 weeks.

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Eligibility Criteria

Inclusion Criteria:

At least 18 years of age
International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM

Exclusion Criteria:

Unable to provide consent
Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3
Hemoglobin < 8 g/dL
Women who are pregnant
Prior history of adverse events with conscious sedation

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

80

Study ID:

NCT03119883

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There is 1 Location for this study

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Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Wilson I. Gonsalves, M.D.
Principal Investigator

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Study is for people with:

Multiple Myeloma

Estimated Enrollment:

80

Study ID:

NCT03119883

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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