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
| Type | Name | Description |
|---|---|---|
| OTHER | 5-Carbon C 13-labeled Glutamine | Given IV |
| PROCEDURE | Biospecimen Collection | Undergo collection of blood |
| PROCEDURE | Biospecimen Collection | Undergo collection of bone marrow aspirate samples |
| OTHER | Uniformly-labeled [13C]glucose | Given 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.