240 Participants Needed

Gut Microbiome for Multiple Myeloma

(Microbiome Trial)

SA
LH
Overseen ByLaura Hawkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the gut microbiome—the community of bacteria and other microorganisms in the digestive system—in individuals with POEMS syndrome and other plasma cell disorders. Researchers seek to understand how these conditions might affect gut health, particularly before treatments like chemotherapy or stem cell transplants begin. The trial divides participants into groups: those newly diagnosed with conditions such as multiple myeloma and amyloidosis, those in remission from POEMS syndrome, and healthy household members without recent gastrointestinal issues or cancer treatments. Participants should have been diagnosed with one of these conditions but not yet received certain treatments or undergone major gastrointestinal interventions recently.

As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance understanding of gut health in plasma cell disorders.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you have used antibiotics or had chemotherapy in the last 3 months, you may not be eligible to participate.

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the gut microbiome's role in plasma cell disorders, including POEMS syndrome, multiple myeloma, and AL amyloidosis. Unlike traditional treatments that focus on chemotherapy, radiation, or stem cell transplants, this study investigates how gut bacteria might influence disease progression and patient health. By understanding these microbiome connections, there could be potential to develop new, non-invasive therapies that complement or enhance existing treatments. This approach could lead to more personalized medicine strategies, tailoring treatments based on an individual's gut microbiome profile.

Who Is on the Research Team?

AD

Angela Dispenzieri, M.D.

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with POEMS syndrome, multiple myeloma, MGUS, AL amyloidosis, or I am a healthy household member of someone who is.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

Stool samples are collected from participants using a self-collection kit

Baseline

Analysis

Samples are evaluated for characteristics of gut microbiome (α-diversity and β-diversity)

4 weeks

Follow-up

Participants are monitored for changes in gut microbiome characteristics

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Non-interventional study

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Poems in Remission GROUPExperimental Treatment1 Intervention
Group II: Poems at diagnosis GROUPExperimental Treatment1 Intervention
Group III: MULTIPLE MYELOMA at diagnosis GROUPExperimental Treatment1 Intervention
Group IV: MGUS GROUPExperimental Treatment1 Intervention
Group V: Health controls in same household GROUPExperimental Treatment1 Intervention
Group VI: Amyloid at diagnosis GROUPExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+