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Amino Acid

Glutamine Metabolism Tracking for Multiple Myeloma

N/A

Recruiting

Led By Wilson I Gonsalves, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 day

Awards & highlights

Study Summary

This trial will compare how well cancer cells in the bone marrow use glutamine after infusion of 13-carbon labelled glutamine.

Who is the study for?

This trial is for adults over 18 with monoclonal gammopathy or multiple myeloma, as defined by the International Myeloma Working Group. It's not suitable for those unable to consent, with severe health limitations (ECOG >3), very low hemoglobin levels, pregnant women, or a history of bad reactions to sedation.Check my eligibility

What is being tested?

The study is examining how bone marrow plasma cells in patients use glutamine differently between early-stage (MGUS) and advanced (multiple myeloma) disease. Participants will have their plasma cells analyzed using labeled glucose and glutamine to track metabolic changes.See study design

What are the potential side effects?

Since this trial involves biospecimen collection rather than drug testing, side effects are minimal but may include discomfort from blood draws or potential risks associated with conscious sedation used during specimen collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from 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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (biospecimen collection, glutamine, glucose)Experimental Treatment3 Interventions

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.

Group II: Group I (biospecimen collection)Experimental Treatment1 Intervention

EX-VIVO: After an overnight fast of 6 hours, patients undergo collection of bone marrow aspirate samples.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,925,774 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,766,958 Total Patients Enrolled

Wilson I Gonsalves, M.D.Principal InvestigatorMayo Clinic in Rochester

Media Library

5-Carbon C 13-labeled Glutamine (Amino Acid) Clinical Trial Eligibility Overview. Trial Name: NCT03119883 — N/A

Monoclonal Gammopathy Research Study Groups: Group I (biospecimen collection), Group II (biospecimen collection, glutamine, glucose)

Monoclonal Gammopathy Clinical Trial 2023: 5-Carbon C 13-labeled Glutamine Highlights & Side Effects. Trial Name: NCT03119883 — N/A

5-Carbon C 13-labeled Glutamine (Amino Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03119883 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment currently open?

"Affirmative. The information located on clinicaltrials.gov denotes that this study is presently in search of participants, with the original launch date being July 21st 2018 and last updated February 10th 2022. 100 patients are needed to be recruited from 1 medical centre for the trial."

Answered by AI

What is the most significant figure for participants in this research?

"Affirmative. Clinicaltrials.gov records detail that this research project, initially established on July 21st 2018, is accepting participants at present. It requires enlistment of 100 individuals from a single location."

Answered by AI

Recent research and studies

Cancer & MetabolismJournal

In Vivo Assessment of Glutamine Anaplerosis into the TCA Cycle in Human Pre-malignant and Malignant Clonal Plasma Cells

Gonsalves, Wilson I., Jin Sung Jang, Erik Jessen, Taro Hitosugi, Laura A. Evans, Dragan Jevremovic, Xuan-Mai Pettersson, et al.. 2020. “In Vivo Assessment of Glutamine Anaplerosis into the TCA Cycle in Human Pre-malignant and Malignant Clonal Plasma Cells”. Cancer & Metabolism. Springer Science and Business Media LLC. doi:10.1186/s40170-020-00235-4.

clinicaltrials.govStudy

Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma

Wilson I. Gonsalves, M.D. 2017. "Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03119883.