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

Recruiting

• Conditions: Plasma Cell Disorders
• Interventions: Other: Non-interventional study (observational)

• Registration Number: NCT06252948
• Lead Sponsor: Mayo Clinic

Brief Summary

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 Timeline

• Study Start: 2021-12-29
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Study First Posted: 2024-02-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MULTIPLE MYELOMA at diagnosis GROUP	Non-interventional study (observational)	Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant
Amyloid at diagnosis GROUP	Non-interventional study (observational)	AL amyloidosis (before starting chemotherapy or stem cell transplant)
Poems at diagnosis GROUP	Non-interventional study (observational)	POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant
Poems in Remission GROUP	Non-interventional study (observational)	POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years
MGUS GROUP	Non-interventional study (observational)	MGUS -not treated newly diagnosed
Health controls in same household GROUP	Non-interventional study (observational)	household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate)

Primary Outcome Measures

Name	Time	Method
Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders	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).

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States