Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders
Microbiome
2 other identifiers
observational
240
1 country
1
Brief Summary
A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2021
CompletedFirst Submitted
Initial submission to the registry
February 2, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2028
February 23, 2026
February 1, 2026
6.9 years
February 2, 2024
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 (α-diversity and β-diversity).
Baseline
Study Arms (6)
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)
Interventions
Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.
Eligibility Criteria
POEMS Syndrome and Other Plasma Cell Disorders
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
Biospecimen
Stool donation will be requested from participants to assess gut microbiome
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Dispenzieri, M.D.
Mayo Clinic in Rochester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2024
First Posted
February 12, 2024
Study Start
December 29, 2021
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 29, 2028
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Gut microbiome (GMB) in patients with active POEMS syndrome will differ from POEMS patients with inactive disease. It will be also different from patients with other plasma cell disorders (amyloid light chain \[AL\] amyloidosis, multiple myeloma \[MM\] and monoclonal gammopathy of undetermined significance \[MGUS\]) and healthy controls.