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| ID | Type | Description | Link |
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| NCI-2022-10547 | Registry Identifier | CTRP (Clinical Trials Reporting Program) |
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A Study to Evaluate Gut Microbiome with POEMS Syndrome and Other Plasma Cell Disorders
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MULTIPLE MYELOMA at diagnosis GROUP | Multiple myeloma (before starting chemotherapy, radiation or stem cell transplant |
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| Amyloid at diagnosis GROUP | AL amyloidosis (before starting chemotherapy or stem cell transplant) |
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| Poems at diagnosis GROUP | POEMS at diagnosis (before starting chemotherapy, radiation, or stem cell transplant |
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| Poems in Remission GROUP | POEMS in remission (no chemotherapy, radiation, or stem cell transplant for 2 years |
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| MGUS GROUP | MGUS -not treated newly diagnosed |
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| Health controls in same household GROUP | household member to be a healthy control (no chemotherapy or gastrointestinal illness to participate) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional study (observational) | Other | Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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POEMS Syndrome and Other Plasma Cell Disorders
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Hawkins | Contact | 507-538-1308 | hawkins.laura@mayo.edu | |
| Sarah Aug | Contact | 507538-1301 | aug.sarah@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Dispenzieri, M.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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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.
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Stool donation will be requested from participants to assess gut microbiome
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