Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventional study (observational).
- Who it may be relevant to
- Registry conditions: Plasma Cell Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Non-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Primary outcome measures
- Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders [Time frame: Baseline]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06252948 · 20-013316 · NCI-2022-10547