Assessing Glutamine Metabolism in MGUS and Myeloma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - IMWG criteria for the diagnosis of either MGUS or MM5.
  • - Presence of measurable disease defined by an M-spike of >1 g/dL and/or involved serum free immunoglobulin light chain >10 mg/dL.
For MGUS cohort only:
  • - At least 5 to <10% cPCs in the prior BM aspirate.
  • - Not received any plasma cell directed therapy.
For MM cohort.
  • - At least >10% cPCs in recent BM aspirate.
  • - Newly diagnosed MM without receiving any plasma cell directed therapy OR Relapsed MM without having received salvage chemotherapy.

Exclusion Criteria:

For both MGUS and MM cohorts.
  • - Unable to provide consent.
  • - ECOG PS >1.
  • - Hemoglobin <10 g/dL.
  • - GFR <50 ml/min.
  • - Women who are pregnant.
  • - Abnormal liver function tests.
- Abnormal bleeding history or coagulation profile (INR >1.5) - Prior history of adverse events with conscious sedation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03119883
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Myeloma, MGUS
Additional Details

Multiple myeloma (MM) is always preceded by a pre-malignant asymptomatic phase, monoclonal gammopathy of undetermined significance (MGUS). Given the incurable nature of MM it is vital to study the development of MM from MGUS to help in identifying early diagnostic and treatment opportunities. This project aims to determine if glutamine metabolism in plasma cells is vital for their survival and whether it is associated with the progression of MGUS to MM. It will involve the utilization of stable isotope resolved metabolomics methods to evaluate the utilization of glutamine by the bone marrow plasma cells in MGUS compared to MM. Patients with MGUS and MM will undergo bone marrow aspirations after being infused with 13-carbon labelled glutamine. The subsequent bone marrow plasma cells obtained from these aspirates will undergo GC-MS assessments of the TCA cycle isotopomers. This will help determine the differences in the utilization of glutamine by the bone marrow plasma cells between MGUS and MM.

Arms & Interventions

Arms

Other: MGUS group

MGUS patients will undergo an intervention which includes an intravenous infusion of 13-Carbon labeled glutamine prior to undergoing a bone marrow aspiration to acquire their bone marrow plasma cells. The glutamine utilization by these bone marrow plasma cells will be assessed by gas-chromatography mass spectrometry by measuring the 13C isotopomer enrichment in the plasma cells.

Other: Multiple Myeloma group

Multiple Myeloma patients will undergo an intervention which includes an intravenous infusion of 13-Carbon labeled glutamine prior to undergoing a bone marrow aspiration to acquire their bone marrow plasma cells. The glutamine utilization by these bone marrow plasma cells will be assessed by gas-chromatography mass spectrometry by measuring the 13C isotopomer enrichment in the plasma cells.

Interventions

Other: - Infusion of 13-Carbon labeled Glutamine

Intravenous infusion of 13-Carbon labeled glutamine followed by bone marrow aspiration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic, Rochester, Minnesota

Status

Recruiting

Address

Mayo Clinic

Rochester, Minnesota, 55905

Site Contact

Wilson Gonsalves

gonsalves.wilson@mayo.edu

507-284-2511