Dysregulation of Glutamine Utilization in the Pathogenesis of Multiple Myeloma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Percent enrichment of 13-Carbon in the tricarboxylic acid (TCA) cycle intermediates within bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group I (biospecimen collection)
EX-VIVO: After an overnight fast of 6 hours, patients undergo collection of bone marrow aspirate samples.
Intervention: Biospecimen Collection (Procedure)
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.
Intervention: 5-Carbon C 13-labeled Glutamine (Other)
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.
Intervention: Biospecimen Collection (Procedure)
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.
Intervention: Uniformly-labeled [13C]glucose (Other)
Outcomes
Primary Outcomes
Percent enrichment of 13-Carbon in the tricarboxylic acid (TCA) cycle intermediates within bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) and multiple myeloma
Time Frame: Up to 1 day
Will compare the glutamine anaplerosis activity in bone marrow clonal plasma cells between patients with MGUS and multiple myeloma.
Secondary Outcomes
- Percent enrichment of 13-Carbon in the TCA cycle intermediates within the peripheral blood plasma from patients with MGUS and multiple myeloma(Up to 1 day)
- Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from patients with MGUS and multiple myeloma(Up to 1 day)