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Trial record 6 of 1741 for:    "Mayo Clinic" [Exact]

Assessing Glutamine Metabolism in MGUS and Myeloma

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Wilson I. Gonsalves, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03119883
First received: April 12, 2017
Last updated: April 14, 2017
Last verified: April 2017
  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.

Condition Intervention
Myeloma
MGUS
Other: Infusion of 13-Carbon labeled Glutamine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Basic Science
Official Title: Dysregulation of Glutamine Metabolism in the Pathogenesis of Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma cells from patients with MGUS and Multiple Myeloma. [ Time Frame: 1 day ]
    Compare the glutamine anaplerosis activity in bone marrow clonal plasma cells between patients with MGUS and Multiple Myeloma.


Secondary Outcome Measures:
  • Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from patients with MGUS and Multiple Myeloma. [ Time Frame: 1 day ]
    Compare the glutamine anaplerosis activity in the plasma cells by assessing the bone marrow plasma between patients with MGUS and Multiple Myeloma.

  • Percent enrichment of 13-Carbon in the TCA cycle intermediates within the peripheral blood plasma from patients with MGUS and Multiple Myeloma. [ Time Frame: 1 day ]
    Compare the peripheral blood enrichment of 13-carbon in the TCA cycle intermediates from patients with MGUS and Multiple Myeloma.


Estimated Enrollment: 80
Anticipated Study Start Date: July 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Infusion of 13-Carbon labeled Glutamine
Intravenous infusion of 13-Carbon labeled glutamine followed by bone marrow aspiration
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.
Other: Infusion of 13-Carbon labeled Glutamine
Intravenous infusion of 13-Carbon labeled glutamine followed by bone marrow aspiration

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03119883

Contacts
Contact: Wilson I Gonsalves, MD 507-284-2511 gonsalves.wilson@mayo.edu

Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Wilson I. Gonsalves, M.D., Senior Associate Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03119883     History of Changes
Other Study ID Numbers: 17-003133
Study First Received: April 12, 2017
Last Updated: April 14, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mayo Clinic:
Myeloma
Metabolism
Glutamine

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 25, 2017