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

Plasma Cell Disorders Clinical Trial

— Microbiome  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252948
• Other study ID #: 20-013316
• Secondary ID: NCI-2022-10547
• Status: Recruiting
• Start date: December 29, 2021
• Est. completion date: December 29, 2028

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Laura Hawkins
• Phone: 507-538-1308
• Email: hawkins.laura[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 29, 2028
• Est. primary completion date: December 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Paraproteinemias
• Plasma Cell Disorders
• POEMS Syndrome

Intervention

Other:
• Gut microbiome studies in patients with POEMS syndrome and other plasma cell disorders.
None-Collection of samples for future analysis

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (a-diversity and ß-diversity).	Baseline

External Links

•   Mayo Clinic Clinical Trials