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Assessing Glutamine Metabolism in MGUS and Myeloma

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ClinicalTrials.gov Identifier: NCT03119883
Recruitment Status : Recruiting
First Posted : April 19, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Wilson I. Gonsalves, M.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE April 12, 2017
First Posted Date  ICMJE April 19, 2017
Last Update Posted Date May 3, 2019
Actual Study Start Date  ICMJE July 21, 2018
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03119883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Glutamine Metabolism in MGUS and Myeloma
Official Title  ICMJE Dysregulation of Glutamine Metabolism in the Pathogenesis of Multiple Myeloma
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Myeloma
  • MGUS
Intervention  ICMJE Other: Infusion of 13-Carbon labeled Glutamine
Intravenous infusion of 13-Carbon labeled glutamine followed by bone marrow aspiration
Study Arms  ICMJE
  • 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.
    Intervention: Other: Infusion of 13-Carbon labeled Glutamine
  • 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.
    Intervention: Other: Infusion of 13-Carbon labeled Glutamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date May 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Wilson I Gonsalves, MD 507-284-2511 gonsalves.wilson@mayo.edu
Contact: Colleen Irlbeck 507-284-2511 irlbeck.colleen@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119883
Other Study ID Numbers  ICMJE 17-003133
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wilson I. Gonsalves, M.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mayo Clinic
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP