[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"smoldering-multiple-myeloma-smm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:smoldering-multiple-myeloma-smm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,78,107,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100053511","chaamp-charlotte-advocate-mgus-project-internal-pilot-study-100053511",false,"NCT06644625","CHAAMP (CHArlotte Advocate MGUS Project) Internal Pilot Study","SCREENING Inclusion Criteria:\n\n* Age 30 years or older at the time of consent\n* Either:\n\n  1. Self-identify as Black and\u002For African American OR\n  2. First-degree relatives (parents, siblings, or children) of patients of any race or ethnicity diagnosed with a plasma cell disorder, including MGUS, smoldering multiple myeloma (SMM), multiple myeloma (MM), solitary plasmacytoma, plasma cell leukemia, AL amyloidosis, POEMS syndrome, and Waldenström's Macroglobulinemia\n* Capable and willing to provide informed consent. NOTE: HIPAA (Health Insurance Portability and Accountability Act) authorization for the release of personal health information may be included in the informed consent or obtained separately\n* Reside in Charlotte, NC, or the surrounding area, based on self-report\n\nSCREENING Exclusion Criteria:\n\n* Self-reported history of MGUS, SMM, MM, AL amyloidosis, plasma cell leukemia, solitary plasmacytoma, Waldenstrom Macroglobulinemia, and POEMS.\n\nLONGITUDINAL Inclusion Criteria:\n\n* Test positive for monoclonal gammopathy during screening portion of the study\n* Consent to the longitudinal portion of the study\n\nLONGITUDINAL Exclusion Criteria:\n\n* The participant previously underwent diagnostic work up as part of CHAAMP Internal Pilot that did not result in a diagnosis of MGUS, Smoldering Multiple Myeloma or other non-plasma cell disorder.",true,"ALL","30 Years",{"count":19,"type":20},1665,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to identify multiple myeloma in the precancerous MGUS stage in order to reduce the risk of delayed diagnosis of multiple myeloma, decrease morbidity related to multiple myeloma at progression, and improve long term outcomes.",[24,25,26,27,28],"Multiple Myeloma","Multiple Myeloma Progression","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Smoldering Multiple Myeloma (SMM)","Plasma Cell Disorders",[30,31,32],"multiple myeloma","hematology","plasma cell disorders","RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":37},"2025-03-01",{"date":41,"type":20},"2035-01",{"name":43,"class":44},"Wake Forest University Health Sciences","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100526882","phase-2-a-proof-of-concept-study-to-learn-whether-linvoseltamab-can-eliminate-abnormal-plasma-cells-that-may-lead-to-multiple-myeloma-in-adult-patients-with-high-risk-monoclonal-gammopathy-of-undetermined-significance-or-non-high-risk-smoldering-multiple-myeloma-100526882","NCT06140524","A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma","Phase 2 Dose-Ranging and Interception Study of Linvoseltamab in Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma","LINKER-MGUS1","Key Inclusion Criteria:\n\n1. HR-MGUS or NHR-SMM as defined in the protocol\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n3. Adequate hematologic and hepatic function, as described in the protocol\n4. Estimated glomerular filtration rate (GFR) ≥30 mL\u002Fmin\u002F1.73 m\\^2 by the Modification of Diet in Renal Disease (MDRD) equation\n\nKey Exclusion Criteria:\n\n1. High-risk SMM, as defined in the protocol\n2. Evidence of any of myeloma-defining events, as described in the protocol\n3. Diagnosis of systemic light-chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), solitary plasmacytoma, or symptomatic MM\n4. Clinically significant cardiac or vascular disease within 3 months of study enrollment, as described in the protocol\n5. Any infection requiring hospitalization or treatment with intravenous (IV) anti-infectives within 28 days of the first dose of linvoseltamab\n6. Uncontrolled Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection; or other uncontrolled infection or unexplained signs of infection, as described in the protocol\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply","18 Years",{"count":56,"type":20},116,"INTERVENTIONAL",[59],"PHASE2","This study is researching an investigational drug called linvoseltamab (\"study drug\") in participants at moderate risk of developing multiple myeloma (about 3 to 10% average annual risk), a group that consists of patients with precancerous conditions called High-Risk Monoclonal Gammopathy of Undetermined Significance (HR-MGUS) and Non-High-Risk Smoldering Multiple Myeloma (NHR-SMM).\n\nThe primary purpose of the study is to understand how well the study drug can eliminate abnormal plasma cells and laboratory signs of HR-MGUS and NHR-SMM.\n\nThe study is looking at several other research questions, including:\n\n* How many participants treated with linvoseltamab have improvement of their HR-MGUS or NHR-SMM?\n* What side effects may happen from taking the study drug?\n* How much study drug is in the blood at different times?\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects).",[26,27],[63,64,65,66,32],"linvoseltamab","monoclonal immunoglobulin (M-protein)","cancer interception","immunotherapy","2026-06-12",{"date":69,"type":37},"2026-06-15",{"date":71,"type":37},"2024-09-16",{"date":73,"type":20},"2032-05-18",{"name":75,"class":76},"Regeneron Pharmaceuticals","INDUSTRY",39,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":15,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100609418","integrative-multi-omics-analysis-to-predict-monoclonal-gammopathies-clinical-evolution-100609418","NCT07214324","Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution","PNRR-2022-1237","Inclusion Criteria:\n\n* Age \\>18 years\n* Male or female patients\n* Histologically confirmed diagnosis of MGUS, SMM, or MM according to ESMO 2021 guidelines\n* Willing and able to provide written informed consent\n\nHEALTHY VOLUNTEERS (HV)\n\n* Age \\>60 years\n* Diagnosis of osteoarthritis (OA)\n* Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty)\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Patients:\n\n  * Active current infection\n  * Autoimmune disease\n  * Women of childbearing potential unable to exclude pregnancy\n  * Use of high-dose corticosteroids within the past 7 days, potentially affecting immunome composition\n\nHealthy Volunteers:\n\n* Prior joint surgery or severe joint deformity\n* Recent trauma, osteonecrosis, or OA caused by prior\u002Fcurrent joint infection\n* Metabolic disorders\n* Previous or current cancer diagnosis\n* Autoimmune diseases (e.g., rheumatoid arthritis)",{"count":86,"type":20},60,"This prospective, multicenter, observational study aims to identify molecular and immunological markers associated with disease progression in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). By integrating genomic, transcriptomic, immunophenotypic, and oral microbiome analyses, the study seeks to characterize the biological mechanisms underlying the transition to symptomatic multiple myeloma (MM). The study also includes in vitro modeling to investigate bone damage and immune dysfunction. Healthy volunteers (HV) undergoing joint replacement surgery for osteoarthritis will serve as controls. The ultimate goal is to improve early risk stratification and support future preventive strategies through a multi-omics approach. There is a pressing need for new strategies to identify high-risk individuals based on biological rather than purely clinical parameters. This study proposes an integrative, multi-omics approach to investigate the transition from MGUS\u002FSMM to MM. By analyzing the immunome and oral microbiome alongside molecular profiling, the goal is to identify reliable biomarkers of progression. The resulting insights could be enable more accurate risk stratification and guide the design of future preventive clinical trials aimed at delaying or halting disease evolution.",[26,27,89],"Multiple Myeloma (MM)",[91,92,93,94,95],"plasma cells","multi-omics","biomarkers","bone marrow microenvironment","microbiome","2026-04-22",{"date":98,"type":37},"2026-04-23",{"date":100,"type":37},"2025-03-17",{"date":102,"type":20},"2026-12-31",{"name":104,"class":105},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",4,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":57,"phases":117,"briefSummary":119,"conditions":120,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":5},"100598304","a-prospective-multicenter-study-of-the-effects-of-plant-based-diets-on-gut-microbiome-and-derived-metabolites-in-patients-affected-by-smoldering-multiple-myeloma-100598304","NCT07069751","A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma","HiFi-MM","Inclusion Criteria:\n\n1. Participant is willing and able to give informed consent for participation in the study.\n2. Confirmed diagnosis of sMM according to IMWG criteria\n3. Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).\n4. Aged ≥18 and \\\u003C\u002F= 75 years\n5. Participant is willing to comply with all study-related procedures.\n6. ECOG performance status of 0-1.\n\nExclusion Criteria:\n\n1. Non-Caucasian subjects. Racial disparities in all stages of the disease characterize MM, and Blacks have an increased MGUS and MM risk and higher mortality rate than Whites.\n2. Patients that already follow a whole food plant-based diet (≥ 40g\u002Fdie;ovo-lacto-vegetarian or processed junk food vegan diets are not excluded). These patients likely should already have high SCFA levels in their gut.\n3. Legume allergy.\n4. Severe allergies such as anaphylactic shock to nuts (specifically cashews).\n5. Concurrent participation in weight loss\u002Fdietary\u002Fexercise programs because of potential conflicts between the concurrent diet and high-fiber diet.\n6. Enrollment onto any other therapeutic investigational study.\n7. Concurrent pregnancy.\n8. Ongoing treatment for HBV, HCV or HIV.\n9. If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.\n10. Heavy drinker (defined as \\>2 drinks per day or \\>14 drinks per week).\n11. Current self-reported illicit drug use (e.g., heroin, cocaine not marijuana).\n12. Subjects that did not accept to sign the informed consent.\n13. Subjects reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy, or prophylaxis. Antibiotic therapy dramatically modifies the composition of the gut microbiota.\n14. Subjects affected by autoimmune diseases except for thyroiditis, and patients affected by small and large intestine dysfunctions (i.e., inflammatory bowel disease).\n15. Gammopathy-associated conditions beyond sMM (e.g. amiloydosis, POEMS, LCDD, etc).","75 Years",{"count":116,"type":20},62,[118],"NA","Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8\u002FTh17 ratio in sMM patients, thus preventing evolution to MM. Goal of this national, prospective, multicenter study is to demonstrate that plant-based diets substantially modify the gut microbiome inducing increased production of SCFAs in patients affected by sMM. The study will involve up to 62 patients affected by sMM. 56 Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will choose among a list of different diet plans or individual food according to the personal tastes and preference. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. As in line with routine diagnosis and follow-up of for patients affected by sMM, the investigators will collect bone marrow aspirates and peripheral blood at the time of screening, for plasma, serum, and peripheral blood mononuclear cells (PBMCs), while stool samples will be collected immediately before diet initiation. The investigators will also collect stool samples 4 and 12 weeks after diet initiation, and peripheral blood at 12 weeks after study initiation (as per routine clinical follow-up of this patient population). Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. Biological paired comparison will be conducted between data obtained from samples collected at time 0 and samples collected 4 and 12 weeks later.",[27],[95,122,123,124],"plant-based diets","gut microbiome","smoldering multiple myeloma","2026-03-30",{"date":127,"type":37},"2026-04-03",{"date":129,"type":37},"2025-10-31",{"date":131,"type":20},"2029-05-31",{"name":133,"class":44},"Ciceri Fabio",{"id":135,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":137,"keywords":138,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":143,"leadSponsor":144,"locationsCount":45},"100565626",{"count":19,"type":20},[24,25,26,27,28],[30,31,32],"2026-01-15",{"date":141,"type":37},"2026-01-20",{"date":39,"type":37},{"date":41,"type":20},{"name":43,"class":44}]