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

Mayo Clinic

Status: Enrolling

Conditions: Plasma Cell Disorders

Treatments: Other: Non-interventional study (observational)

Study type: Observational

Funder types: Other

Identifiers

NCT06252948

20-013316

NCI-2022-10547 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

240 participants in 6 patient groups

MULTIPLE MYELOMA at diagnosis GROUP

Description:

Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant

Treatment:

Other: Non-interventional study (observational)

Amyloid at diagnosis GROUP

Description:

AL amyloidosis (before starting chemotherapy or stem cell transplant)

Treatment:

Other: Non-interventional study (observational)

Poems at diagnosis GROUP

Description:

POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant

Treatment:

Other: Non-interventional study (observational)

Poems in Remission GROUP

Description:

POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years

Treatment:

Other: Non-interventional study (observational)

MGUS GROUP

Description:

MGUS -not treated newly diagnosed

Treatment:

Other: Non-interventional study (observational)

Health controls in same household GROUP

Description:

household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate)

Treatment:

Other: Non-interventional study (observational)