Plasma Cell Disorders
Conditions
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.
Interventions
OTHERNon-interventional study (observational)
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTLaura Hawkins
CONTACTSarah Aug
PRINCIPAL_INVESTIGATORAngela Dispenzieri, M.D.
Mayo Clinic in Rochester
Outcome results
None listed