Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06252948

Conditions

Plasma Cell Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Non-interventional study (observational)

Study Details

Brief summary:

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

Conditions

Plasma Cell Disorders

Study ID

NCT06252948

Start date

Dec 29, 2021

Status verified date

Feb, 2026

Completion date

Dec 29, 2028

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

240 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Non-interventional study (observational)

Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.

Primary outcome measure

  • Gut Microbiome characteristics in patients with POEMS syndrome and other plasma cell disorders [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Laura Hawkins

507-538-1308hawkins.laura@mayo.edu

Sarah Aug

507538-1301aug.sarah@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Laura Hawkins

507-538-1308hawkins.laura@mayo.edu

Sarah Aug

507-538-1301aug.sarah@mayo.edu

Principal Investigator:

Angela Dispenzieri, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-23.