Clinical Trials Directory

Trials / Completed

CompletedNCT03119883

Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma

Dysregulation of Glutamine Utilization in the Pathogenesis of Multiple Myeloma

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in MGUS and MM, respectively. It may also allow researchers better determine the transition from MGUS to MM for the development of potential early diagnostic purposes of preventative strategies.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHER5-Carbon C 13-labeled GlutamineGiven IV
PROCEDUREBiospecimen CollectionUndergo collection of blood
PROCEDUREBiospecimen CollectionUndergo collection of bone marrow aspirate samples
OTHERUniformly-labeled [13C]glucoseGiven IV

Timeline

Start date
2017-06-02
Primary completion
2024-06-30
Completion
2024-06-30
First posted
2017-04-19
Last updated
2024-08-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03119883. Inclusion in this directory is not an endorsement.