Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders (Microbiome)

February 19, 2026 updated by: Mayo Clinic
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angela Dispenzieri, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

POEMS Syndrome and Other Plasma Cell Disorders

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MULTIPLE MYELOMA at diagnosis GROUP
Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant
Other: Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Other Names:
  • GMB
Amyloid at diagnosis GROUP
AL amyloidosis (before starting chemotherapy or stem cell transplant)
Other: Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Other Names:
  • GMB
Poems at diagnosis GROUP
POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant
Other: Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Other Names:
  • GMB
Poems in Remission GROUP
POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years
Other: Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Other Names:
  • GMB
MGUS GROUP
MGUS -not treated newly diagnosed
Other: Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Other Names:
  • GMB
Health controls in same household GROUP
household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate)
Other: Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Other Names:
  • GMB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Angela Dispenzieri, M.D., Mayo Clinic in Rochester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 29, 2028

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 12, 2024

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-013316
  • NCI-2022-10547 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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