Monoclonal Gammopathy of Undetermined SignificanceNCT03119883
Dysregulation of Glutamine Activity in the Pathogenesis of Multiple Myeloma
A study testing 5-Carbon C 13-labeled Glutamine, Biospecimen Collection and Uniformly-labeled [13C]glucose in people with Monoclonal Gammopathy of Undetermined Significance and Plasma Cell Myeloma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance, Plasma Cell Myeloma
- What is being tested?
- 5-Carbon C 13-labeled Glutamine, Biospecimen Collection and Uniformly-labeled [13C]glucose
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2017to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM
Who cannot join
- Unable to provide consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3
- Hemoglobin < 8 g/dL
- Women who are pregnant
- Prior history of adverse events with conscious sedation
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Dysregulation of Glutamine Utilization in the Pathogenesis of Multiple Myeloma
This clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in MGUS and MM, respectively. It may also allow researchers better determine the transition from MGUS to MM for the development of potential early diagnostic purposes of preventative strategies.
Read the detailed description
PRIMARY OBJECTIVE:
- Compare the glutamine anaplerosis activity in bone marrow clonal plasma cells (cPCs) between patients with MGUS and MM using an in vivo and an ex vivo approach.
SECONDARY OBJECTIVES:
- Compare the tricarboxylic acid (TCA) isotopomer enrichment in the bone marrow plasma obtained from patients with MGUS and MM with the in vivo approach.
II. Determine the peripheral blood enrichment of 13C in the TCA cycle intermediates from patients with MGUS and MM with the in vivo approach.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I (EX-VIVO): After an overnight fast of 6 hours, patients undergo collection of blood samples.
GROUP II (IN VIVO): After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose intravenously (IV) over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples.
After completion of study, patient are followed up for 4 weeks.
- Being tested
- 5-Carbon C 13-labeled Glutamine, Biospecimen Collection, Uniformly-labeled [13C]glucose
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-Carbon C 13-labeled GlutamineOther
Also called 5-13C-Glutamine, [5-13C]-glutamine, GLUTAMINE 5-C-13
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of bone marrow aspirate samples
Uniformly-labeled [13C]glucoseOther
Also called [U-13C] Glucose, U-13C-Glucose
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Group I (biospecimen collection) | Experimental | EX-VIVO: After an overnight fast of 6 hours, patients undergo collection of bone marrow aspirate samples. Receives: Procedure: Biospecimen Collection |
| Group II (biospecimen collection, glutamine, glucose) | Experimental | 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. Receives: Other: 5-Carbon C 13-labeled Glutamine; Procedure: Biospecimen Collection; Other: Uniformly-labeled [13C]glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Will compare the glutamine anaplerosis activity in bone marrow clonal plasma cells between patients with MGUS and multiple myeloma.
Measured: Up to 1 day
Secondary outcomes (2)
Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from patients with MGUS and multiple myeloma
Will compare the glutamine anaplerosis activity in the plasma cells by assessing the bone marrow plasma between patients with MGUS and multiple myeloma.
Measured: Up to 1 day
Percent enrichment of 13-Carbon in the TCA cycle intermediates within the peripheral blood plasma from patients with MGUS and multiple myeloma
Will compare the peripheral blood enrichment of 13-carbon in the TCA cycle intermediates from patients with MGUS and multiple myeloma.
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start2 Jun 2017
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Monoclonal Gammopathy of Undetermined SignificanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Wilson I Gonsalves, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119883
- Sponsor's protocol ID
- 17-003133
- Other IDs
- NCI-2021-02642, K23CA218742
- Status last verified
- Aug 2024
- First submitted
- 12 Apr 2017
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.
PubMed 33308307
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysregulation of Glutamine Utilization in the Pathogenesis of Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03119883
- Acronym / sponsor ID
- 17-003133
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 19 Apr 2017 (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 clinical trial studies the utilization of glutamine by the bone marrow plasma cells from patients with monoclonal gammopathy of undetermined significance (MGUS) compared to multiple myeloma (MM). Results from this study may identify metabolic differences between pre-malignant and malignant clonal plasma cells in MGUS and MM, respectively. It may also allow researchers better determine the transition from MGUS to MM for the development of potential early diagnostic purposes of preventative strategies.
Detailed description
PRIMARY OBJECTIVE:
- Compare the glutamine anaplerosis activity in bone marrow clonal plasma cells (cPCs) between patients with MGUS and MM using an in vivo and an ex vivo approach.
SECONDARY OBJECTIVES:
- Compare the tricarboxylic acid (TCA) isotopomer enrichment in the bone marrow plasma obtained from patients with MGUS and MM with the in vivo approach.
II. Determine the peripheral blood enrichment of 13C in the TCA cycle intermediates from patients with MGUS and MM with the in vivo approach.
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I (EX-VIVO): After an overnight fast of 6 hours, patients undergo collection of blood samples.
GROUP II (IN VIVO): After an overnight fast of 6 hours, patients receive 13-carbon labeled glutamine or 13-carbon-labeled glucose intravenously (IV) over 90 minutes. Patients also undergo collection of blood and bone marrow aspirate samples.
After completion of study, patient are followed up for 4 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (biospecimen collection) | Experimental | Procedure: Biospecimen CollectionEX-VIVO: After an overnight fast of 6 hours, patients undergo collection of bone marrow aspirate samples. |
| Group II (biospecimen collection, glutamine, glucose) | Experimental | Other: 5-Carbon C 13-labeled Glutamine, Procedure: Biospecimen Collection, Other: Uniformly-labeled [13C]glucoseIN 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age
- International Myeloma Working Group (IMWG) criteria for the diagnosis of either MGUS or MM
Key exclusion criteria (5 listed)
- Unable to provide consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3
- Hemoglobin < 8 g/dL
- Women who are pregnant
- Prior history of adverse events with conscious sedation
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 |
|---|---|---|
| 5-Carbon C 13-labeled GlutamineAlso: 5-13C-Glutamine, [5-13C]-glutamine, GLUTAMINE 5-C-13Given IV | Other | Group II (biospecimen collection, glutamine, glucose) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood | Procedure or surgery | Group II (biospecimen collection, glutamine, glucose) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of bone marrow aspirate samples | Procedure or surgery | Group I (biospecimen collection), Group II (biospecimen collection, glutamine, glucose) |
| Uniformly-labeled [13C]glucoseAlso: [U-13C] Glucose, U-13C-GlucoseGiven IV | Other | Group II (biospecimen collection, glutamine, glucose) |
Primary outcome
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
Time frame: Up to 1 day
Will compare the glutamine anaplerosis activity in bone marrow clonal plasma cells between patients with MGUS and multiple myeloma.
2 secondary outcomes
Percent enrichment of 13-Carbon in the TCA cycle intermediates within bone marrow plasma from patients with MGUS and multiple myeloma
Time frame: Up to 1 day
Percent enrichment of 13-Carbon in the TCA cycle intermediates within the peripheral blood plasma from patients with MGUS and multiple myeloma
Time frame: Up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 33308307Gonsalves WI, Jang JS, Jessen E, Hitosugi T, Evans LA, Jevremovic D, Pettersson XM, Bush AG, Gransee J, Anderson EI, Kumar SK, Nair KS. In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells. Cancer Metab. 2020 Dec 11;8(1):29. doi: 10.1186/s40170-020-00235-4.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Wilson I Gonsalves, M.D. 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?
A study testing 5-Carbon C 13-labeled Glutamine, Biospecimen Collection and Uniformly-labeled [13C]glucose in people with Monoclonal Gammopathy of Undetermined Significance and Plasma Cell Myeloma, 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 9 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: Up to 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03119883, which also lists 1 linked publication.
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 9 Aug 2024.