Assessing Glutamine Metabolism in MGUS and Myeloma
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003133
NCT ID: NCT03119883
Sponsor Protocol Number: 17-003133
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 < 8g/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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Wilson Gonsalves, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available