[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06252948":3,"trial-entities:NCT06252948":97,"trial-summary:NCT06252948":104},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":21,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":60,"locations":63,"central_contacts":86,"overall_officials":90,"references":92,"see_also_links":93},"NCT06252948","20-013316","Gut Microbiome Studies in Patients With POEMS Syndrome and Other Plasma Cell Disorders","RECRUITING","2028-12-29","2026-02","2026-02-23","2021-12-29","Mayo Clinic","OTHER",false,"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.",[18],"Plasma Cell Disorders",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},240,"ESTIMATED",[27],{"type":13,"name":28,"description":29,"armGroupLabels":30,"otherNames":37},"Non-interventional study (observational)","Participants undergo stool sample collection, complete surveys, and have their medical record reviewed on study.",[31,32,33,34,35,36],"Amyloid at diagnosis GROUP","Health controls in same household GROUP","MGUS GROUP","MULTIPLE MYELOMA at diagnosis GROUP","Poems at diagnosis GROUP","Poems in Remission GROUP",[38],"GMB",[40],{"measure":41,"description":42,"timeFrame":43},"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",[],"ALL","18 Years",true,{"inclusion":49,"exclusion":51,"raw_text":59},[50],"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",[52,53,54,55,56,57,58],"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)","Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Age under 18 years\n* Pregnancy\n* Substance abuse\n* Antibiotics use or gastrointestinal endoscopy in the 3 months prior to the study participation\n* Chronic gastrointestinal disorder\n* Gastrointestinal surgeries in the past 2 years\n* 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)",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":83},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[71,76,80],{"name":72,"role":73,"phone":74,"email":75},"Laura Hawkins","CONTACT","507-538-1308","hawkins.laura@mayo.edu",{"name":77,"role":73,"phone":78,"email":79},"Sarah Aug","507-538-1301","aug.sarah@mayo.edu",{"name":81,"role":82},"Angela Dispenzieri, M.D.","PRINCIPAL_INVESTIGATOR",{"lat":84,"lon":85},44.02163,-92.4699,[87,88],{"name":72,"role":73,"phone":74,"email":75},{"name":77,"role":73,"phone":89,"email":79},"507538-1301",[91],{"name":81,"affiliation":65,"role":82},[],[94],{"label":95,"url":96},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":98,"biomarkers":103},[99,100,101,102],"Amyloidosis","Monoclonal Gammopathy of Undetermined Significance","Multiple Myeloma","POEMS Syndrome",[],{"nct_id":4,"found":47,"summary":105,"prompt_version":114},{"design":106,"status":107,"heading":6,"summary":108,"follow_up":109,"word_count":110,"commitments":111,"compensation":112,"drugs_mentioned":113},"This is an observational study planning to enroll 240 participants. It is not testing a new treatment but rather observing existing conditions.","completed","This observational study is looking at the characteristics of the gut microbiome (the community of bacteria and other microorganisms in your intestines) in people with POEMS syndrome (a rare blood disorder affecting nerves and other body systems) and other plasma cell disorders like multiple myeloma, MGUS, and AL amyloidosis. Researchers want to understand if the gut microbiome is different in these conditions, especially between active POEMS syndrome and when it's in remission. You might be able to join if you are 18 or older and have been diagnosed with POEMS syndrome (newly diagnosed or in remission), newly diagnosed multiple myeloma, MGUS, or AL amyloidosis. Healthy individuals from households of participants are also eligible. The study will look at your gut microbiome characteristics at the beginning of the study. The current recruitment status is unclear.","Gut microbiome characteristics are measured at Baseline, so there is no specified follow-up period after this initial measurement.",134,"Participants will provide a stool sample, complete surveys, and allow researchers to review their medical records.","Not stated in the trial record.",[],"v2"]