Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma
NCT ID: NCT03119883
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2017-06-02
2024-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Group I (biospecimen collection)
EX-VIVO: After an overnight fast of 6 hours, patients undergo collection of bone marrow aspirate samples.
Biospecimen Collection
Undergo collection of bone marrow aspirate samples
Group II (biospecimen collection, glutamine, glucose)
IN VIVO: After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose IV over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples.
5-Carbon C 13-labeled Glutamine
Given IV
Biospecimen Collection
Undergo collection of blood
Biospecimen Collection
Undergo collection of bone marrow aspirate samples
Uniformly-labeled [13C]glucose
Given IV
Interventions
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5-Carbon C 13-labeled Glutamine
Given IV
Biospecimen Collection
Undergo collection of blood
Biospecimen Collection
Undergo collection of bone marrow aspirate samples
Uniformly-labeled [13C]glucose
Given IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Wilson I Gonsalves, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2021-02642
Identifier Type: REGISTRY
Identifier Source: secondary_id
17-003133
Identifier Type: -
Identifier Source: org_study_id
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