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

NCT ID: NCT06252948

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-29

Study Completion Date

2028-12-29

Brief Summary

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A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders

Detailed Description

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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

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Plasma Cell Disorders

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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MULTIPLE MYELOMA at diagnosis GROUP

Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant

Non-interventional study (observational)

Intervention Type OTHER

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Amyloid at diagnosis GROUP

AL amyloidosis (before starting chemotherapy or stem cell transplant)

Non-interventional study (observational)

Intervention Type OTHER

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Poems at diagnosis GROUP

POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant

Non-interventional study (observational)

Intervention Type OTHER

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Poems in Remission GROUP

POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years

Non-interventional study (observational)

Intervention Type OTHER

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

MGUS GROUP

MGUS -not treated newly diagnosed

Non-interventional study (observational)

Intervention Type OTHER

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Health controls in same household GROUP

household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate)

Non-interventional study (observational)

Intervention Type OTHER

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Interventions

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Non-interventional study (observational)

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Intervention Type OTHER

Other Intervention Names

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GMB

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Dispenzieri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura Hawkins

Role: CONTACT

507-538-1308

Sarah Aug

Role: CONTACT

507538-1301

Facility Contacts

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Laura Hawkins

Role: primary

507-538-1308

Sarah Aug

Role: backup

507-538-1301

Related Links

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Other Identifiers

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NCI-2022-10547

Identifier Type: REGISTRY

Identifier Source: secondary_id

20-013316

Identifier Type: -

Identifier Source: org_study_id

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