Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
Purpose
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
Condition
- Plasma Cell Disorders
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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)
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| MULTIPLE MYELOMA at diagnosis GROUP | Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant |
|
| Amyloid at diagnosis GROUP | AL amyloidosis (before starting chemotherapy or stem cell transplant) |
|
| Poems at diagnosis GROUP | POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant |
|
| Poems in Remission GROUP | POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years |
|
| MGUS GROUP | MGUS -not treated newly diagnosed |
|
| Health controls in same household GROUP | household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate) |
|
Recruiting Locations
Rochester 5043473, Minnesota 5037779 55905
More Details
- NCT ID
- NCT06252948
- Status
- Recruiting
- Sponsor
- Mayo Clinic
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.