Monoclonal Gammopathy of Undetermined Significance (MGUS)NCT07057583
A Study of Carbon 13-based Deep Labelling of Bone Marrow Cells
An observational study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Non-IgM Monoclonal Gammopathy of Undetermined Significance, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Non-IgM Monoclonal Gammopathy of Undetermined Significance
- What is being tested?
- Non-Interventional Study
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a diagnosis of monoclonal gammopathy of undetermined significance (MGUS) and healthy volunteers
Who may be able to join
- All Participants:
- At least age 18 years or older
- Able to provide informed consent
- MGUS Cohort:
- International Myeloma Working Group (IMWG) criteria for the diagnosis of non-IgM MGUS
Who cannot join
- All Participants:
- Unable to provide consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) >1
- Prior history of adverse events with conscious sedation
- Ongoing use of immunosuppressive medications
- All known pregnant and lactating women will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Study of 13Carbon-Based Deep Labeling of Bone Marrow Cells to Map Their Utilization of Extracellular Metabolites
This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment.
Read the detailed description
PRIMARY OBJECTIVE:
- Evaluate differences in the amount of extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs).
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.
GROUP II: Healthy volunteers undergo blood collection and bone marrow aspiration on study.
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Non-IgM Monoclonal Gammopathy of Undetermined Significance
- Being tested
- Non-Interventional Study
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational Group I | Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study. Receives: Other: Non-Interventional Study | |
| Observational Group II | Healthy volunteers undergo blood collection and bone marrow aspiration on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)
Assessed by evaluating blood and bone marrow aspirate samples for mean 13Carbon (13C) percentage enrichment of the mass isotopomers of interest of at least 6 (i.e. the difference between a mean 13C percentage enrichment of a particular mass isotopomer is 12% in the MGUS group and 6% in the healthy participant group or vice versa) using a 2-group t-test with a 2-sided significance level of 0.01.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal Gammopathy of Undetermined Significance (MGUS)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wilson I. Gonsalves, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057583
- Sponsor's protocol ID
- 24-003478
- Other IDs
- NCI-2025-01095, 24-003478, HT9425-24-1-0619
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 13Carbon-Based Deep Labeling of Bone Marrow Cells to Map Their Utilization of Extracellular Metabolites
- ClinicalTrials.gov ID
- NCT07057583
- Acronym / sponsor ID
- 24-003478
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Non-IgM Monoclonal Gammopathy of Undetermined Significance
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a novel laboratory method to study how certain bone marrow cells in the body take up nutrients from their environment.
Detailed description
PRIMARY OBJECTIVE:
- Evaluate differences in the amount of extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs).
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
GROUP I: Patients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study.
GROUP II: Healthy volunteers undergo blood collection and bone marrow aspiration on study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational Group I | – | Other: Non-Interventional StudyPatients undergo blood collection and bone marrow aspiration as part of their standard care and have their medical records reviewed on study. |
| Observational Group II | – | Other: Non-Interventional StudyHealthy volunteers undergo blood collection and bone marrow aspiration on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of monoclonal gammopathy of undetermined significance (MGUS) and healthy volunteers
Key inclusion criteria (5 listed)
- All Participants:
- MGUS Cohort:
Key exclusion criteria (6 listed)
- All Participants:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational Group I, Observational Group II |
Primary outcome
Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs)
Time frame: Up to 30 days
Assessed by evaluating blood and bone marrow aspirate samples for mean 13Carbon (13C) percentage enrichment of the mass isotopomers of interest of at least 6 (i.e. the difference between a mean 13C percentage enrichment of a particular mass isotopomer is 12% in the MGUS group and 6% in the healthy participant group or vice versa) using a 2-group t-test with a 2-sided significance level of 0.01.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wilson I. Gonsalves, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Non-IgM Monoclonal Gammopathy of Undetermined Significance, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracellular uptake of glucose and amino acids (AAs) between pre-malignant clonal plasma cells (cPCs) and polyclonal plasma cells (pPCs) (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.