Plasma Cell DisordersMicrobiomeNCT06252948
Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
An observational study of Plasma Cell Disorders, run by Mayo Clinic at 1 site in United States.
Trial summary
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plasma Cell Disorders
- What is being tested?
- Non-interventional study (observational)
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2021to 29 Dec 2028
- 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: POEMS Syndrome and Other Plasma Cell Disorders
Who may be able to join
- Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), amyloid light chain (AL) amyloidosis or healthy controls from their households
Who cannot join
- Age under 18 years
- Pregnancy
- Substance abuse
- Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
- Chronic gastrointestinal disorder
- Gastrointestinal surgeries in the past 2 years
- Chemotherapy (including anti-plasma cell treatment and steroids) or radiation treatment for cancer within the last 2 years or active cancer (other than plasma cell disorder)
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, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Laura Hawkins, 507-538-1308, hawkins.laura@mayo.edu
Sarah Aug, 507-538-1301, aug.sarah@mayo.edu
About this study
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
Read the detailed description
The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls.
- Conditions
- Plasma Cell Disorders
- Being tested
- Non-interventional study (observational)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional study (observational)Other
Also called GMB
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
| Study group | Role | What they receive |
|---|---|---|
| MULTIPLE MYELOMA at diagnosis GROUP | Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant Receives: Other: Non-interventional study (observational) | |
| Amyloid at diagnosis GROUP | AL amyloidosis (before starting chemotherapy or stem cell transplant) Receives: Other: Non-interventional study (observational) | |
| Poems at diagnosis GROUP | POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant Receives: Other: Non-interventional study (observational) | |
| Poems in Remission GROUP | POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years Receives: Other: Non-interventional study (observational) | |
| MGUS GROUP | MGUS -not treated newly diagnosed Receives: Other: Non-interventional study (observational) | |
| Health controls in same household GROUP | household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate) Receives: Other: Non-interventional study (observational) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders
Stool samples will be collected by the patient using a stool self- collection kit provided to the participant by the study staff. Samples will be evaluated for characteristics of gut microbiome (α-diversity and β-diversity).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start29 Dec 2021
- Primary completion1 Dec 2028 (estimated)
- Study completion29 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Cell DisordersStudies 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
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Dispenzieri, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252948
- Sponsor's protocol ID
- 20-013316
- Other IDs
- NCI-2022-10547
- Acronym
- Microbiome
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Gut microbiome (GMB) in patients with active POEMS syndrome will differ from POEMS patients with inactive disease. It will be also different from patients with other plasma cell disorders (amyloid light chain \[AL\] amyloidosis, multiple myeloma \[MM\] and monoclonal gammopathy of undetermined significance \[MGUS\]) and healthy controls.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
- ClinicalTrials.gov ID
- NCT06252948
- Acronym / sponsor ID
- Microbiome / 20-013316
- Conditions
- Plasma Cell Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 29 Dec 2028 (estimated)
- First posted
- 12 Feb 2024 (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.
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
Detailed description
The characteristics and role of gut microbiome rare plasma cell disorders- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) and amyloid light-chain (AL) amyloidosis, have not been explored; and their pathophysiology is quite elusive. To help understand rare plasma cell disorders and its association with gut microbiome, the investigators will study the stool samples of newly diagnosed POEMS patients and AL amyloidosis and compare it with patients with newly diagnosed monoclonal gammopathy of undetermined significance and multiple myeloma as well as healthy controls. Moreover, gut microbiome in newly diagnosed POEMS patients will be compared to POEMS patients in remission. It is the overall hypothesis that in POEMS patients the gut microbiome signature will differ between active disease (at diagnosis) and inactive disease (in remission), and the gut microbiome in POEMS patients will be different from patients with other plasma cell disorders and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MULTIPLE MYELOMA at diagnosis GROUP | – | Other: Non-interventional study (observational)Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant |
| Amyloid at diagnosis GROUP | – | Other: Non-interventional study (observational)AL amyloidosis (before starting chemotherapy or stem cell transplant) |
| Poems at diagnosis GROUP | – | Other: Non-interventional study (observational)POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant |
| Poems in Remission GROUP | – | Other: Non-interventional study (observational)POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years |
| MGUS GROUP | – | Other: Non-interventional study (observational)MGUS -not treated newly diagnosed |
| Health controls in same household GROUP | – | Other: Non-interventional study (observational)household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- POEMS Syndrome and Other Plasma Cell Disorders
Key inclusion criteria (1 listed)
- Diagnosed with POEMS syndrome (newly diagnosed or in remission) or with newly diagnosed multiple myeloma (MM), monoclonal gammopathy of undetermined significance (MGUS), amyloid light chain (AL) amyloidosis or healthy controls from their households
Key exclusion criteria (7 listed)
- Age under 18 years
- Pregnancy
- Substance abuse
- Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation
- Chronic gastrointestinal disorder
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 study (observational)Also: GMBParticipants undergo stool sample collection, complete surveys, and have their medical record reviewed on study. | Other | Amyloid at diagnosis GROUP, Health controls in same household GROUP, MGUS GROUP, MULTIPLE MYELOMA at diagnosis GROUP, Poems at diagnosis GROUP, Poems in Remission GROUP |
Primary outcome
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders
Time frame: Baseline
Stool samples will be collected by the patient using a stool self- collection kit provided to the participant by the study staff. Samples will be evaluated for characteristics of gut microbiome (α-diversity and β-diversity).
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 23 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Gut microbiome (GMB) in patients with active POEMS syndrome will differ from POEMS patients with inactive disease. It will be also different from patients with other plasma cell disorders (amyloid light chain [AL] amyloidosis, multiple myeloma [MM] and monoclonal gammopathy of undetermined significance [MGUS]) and healthy controls.
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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.
Angela Dispenzieri, 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?
An observational study of Plasma Cell Disorders, 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 1 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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?
Contact Laura Hawkins (507-538-1308, hawkins.laura@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders (time frame: Baseline). 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 23 Feb 2026.