[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"monoclonal-gammopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:monoclonal-gammopathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,86,98,120,143],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053329","pre-malignant-states-to-hematologic-malignancies-in-firefighters-100053329",false,"NCT06870760","Pre-malignant States to Hematologic Malignancies in Firefighters","Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information.\n2. Age ≥ 40-49 years at the time of consent (self-reported)\n3. Ability of the participant to understand and comply with study procedures for the entire length of the study\n4. Currently employed by Charlotte Fire Department (CFD) with at least 5 years on-the -job experience (self-reported)\n\nExclusion Criteria:\n\nAnyone with a current diagnosis of a hematologic malignancy will be excluded.",true,"ALL","40 Years","49 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.",[25,26,27,28,29,30],"Clonal Hematopoiesis of Indeterminate Potential","Monoclonal Gammopathy","Non Hodgkin Lymphoma","Leukemia","Multiple Myeloma","Plasma Cell Disorder",[32,33,34],"Firefighters","CHIP","MGUS","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-06-23",{"date":43,"type":21},"2027-04",{"name":45,"class":46},"Wake Forest University Health Sciences","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":47},"100639454","early-detection-of-amyloidosis-in-monoclonal-gammopathy-using-nuclear-medicine-imaging-100639454","NCT07624760","Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging","Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET\u002FMR: a Prospective, Single-Center, Observational Study","MGUS-PET","Inclusion Criteria:\n\n* Participation in the COSMO-AL study\n* Available biopsy test result\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women","18 Years",{"count":58,"type":21},50,"INTERVENTIONAL",[61],"NA","The goal of this clinical trial is to evaluate whether ¹⁸F-florbetaben PET\u002FMR can detect systemic amyloid deposits early and noninvasively in patients with monoclonal gammopathy. The main question it aims to answer is: Can ¹⁸F-florbetaben PET\u002FMR identify systemic amyloid deposits across clinically and histologically defined patient groups?\n\nParticipants will:\n\n* Be screened for eligibility and asked to sign an informed consent form\n* Have their vital signs measured\n* Receive a single intravenous injection of approximately 300 MBq ¹⁸F-florbetaben (Neuraceq®), followed by whole-body PET\u002FMR imaging from skull base to below the kidneys. If MRI is contraindicated (e.g., pacemaker, severe claustrophobia), PET\u002FCT will be performed instead. The scan takes approximately one hour, during which participants lie still in the scanner\n* Be monitored during and after the scan for any side effects or adverse events\n* Complete study participation at the end of the imaging session (single visit, no follow-up required)",[26,64,29,65,66],"Monoclonal Gammopathy of Undetermined Significance (MGUS)","AL Amyloidosis","Systemic Amyloidosis",[34,68,69,70,71,72,73,74,75],"MGCS","Amyloid PET","PET\u002FMRI","Florbetaben","Early detection","Systemic amyloidosis","Monoclonal gammopathy","AL amyloidosis","NOT_YET_RECRUITING","2026-05-28",{"date":79,"type":39},"2026-06-03",{"date":81,"type":21},"2026-10",{"date":83,"type":21},"2028-05",{"name":85,"class":46},"University of Zurich",{"id":87,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":89,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":47},"100583010",{"count":20,"type":21},[25,26,27,28,29,30],[32,33,34],"2026-04-13",{"date":93,"type":39},"2026-04-16",{"date":95,"type":21},"2026-06",{"date":43,"type":21},{"name":45,"class":46},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":59,"phases":107,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":119},"100409674","phase-2-isatuximab-in-patients-with-monoclonal-gammopathy-of-renal-significance-100409674","NCT04614558","Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance","A Single Arm, Multicenter, Phase II, Open-Label Trial to Evaluate Efficacy of Isatuximab in Patients With Monoclonal Gammopathy of Renal Significance","Inclusion Criteria:\n\n1. Renal biopsy proven diagnosis of an MGRS disorder including the following:\n\n   1. Proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMID)\n   2. C3 glomerulopathy associated with monoclonal gammopathy\n   3. Non-Amyloid Fibrillary Glomerulonephritis\n   4. Light chain Proximal Tubulopathy\n   5. Immunotactoid Glomerulopathy\n\n   A concurrent diagnosis of Monoclonal gammopathy (with +ve Serum and\u002For Urine protein electrophoresis or Bone marrow biopsy) is required in patients with C3 glomerulopathy but not for other disorders. Patients with concurrent MGUS, non-high risk smoldering myeloma are eligible for enrollment.\n2. Measurable Proteinuria ≥1gram over 24 hours.\n3. Prior Therapy: Newly diagnosed as well as patients with previous therapy but persistent renal dysfunction and persistent proteinuria ≥1gram over 24 hours are eligible for enrollment. Patients who received a prior cluster of differentiation 38 (CD38) antibody therapy are not eligible for study. In patients who have received prior therapy a wash out period of 12 weeks for chemotherapy based therapies and 24 weeks for Rituximab based therapies is required between completion of prior therapy and cycle 1 Day1 of study therapy.\n4. Age ≥18 years.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n6. Life expectancy of greater than 6 months\n7. Participants must have normal organ and marrow function as defined below:\n\nLeukocytes ≥3,000\u002Fmicroliters (mcL)\n\n1. absolute neutrophil count ≥1,500\u002FmcL\n2. platelets ≥100,000\u002FmcL\n3. total bilirubin within normal institutional limits\n4. Aspartate aminotransferase (AST) (SGOT)\u002Falanine transaminase (ALT)(SGPT) ≤2.5 × institutional upper limit of normal\n5. Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m2.\n\nExclusion Criteria:\n\n1. Participants who have had chemotherapy based therapy within 12 weeks or Rituximab based therapy within prior 24 weeks prior to starting the cycle 1 Day 1 of trial therapy\n2. Participants who are receiving any other investigational agents concurrently.\n3. History of severe allergic reactions or anaphylaxis attributed to compounds of similar chemical or biologic composition to Isatuximab.\n4. Diagnosis of Multiple Myeloma or High risk smoldering Multiple Myeloma or a B cell lymphoma meeting criteria for therapy.\n5. Renal Biopsy showing the coexistence of other significant diagnosis e.g. diabetic nephropathy.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant and Lactating women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Isatuximab.\n8. HIV-positive Participants are ineligible because of increased risk of lethal infections when treated with immunosuppressive therapy.",{"count":106,"type":21},27,[108],"PHASE2","The purpose of this study is to see whether Isatuximab can help improve kidney function of participants with MGRS. Isatuximab is approved by the Food and Drug Administration (FDA) for the treatment of adult patients with multiple myeloma, but it is not approved by the FDA to treat MGRS. This means that the use of isatuximab in this study is considered 'investigational'.",[26],"2025-06-04",{"date":113,"type":39},"2025-06-06",{"date":115,"type":39},"2021-06-08",{"date":95,"type":21},{"name":118,"class":46},"Columbia University",2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":15,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100573798","multi-center-screening-for-serum-m-protein-100573798","NCT06750965","Multi-center Screening for Serum M Protein","Epidemiological Characteristics Associated With Precursor Lesions of Multiple Myeloma Using Serum M Protein Screening: a Multi-center, Prospective Cohort Study.","Inclusion Criteria:\n\n(1) Screening stage\n\n1. Over 30 years old.\n2. Volunteer to participate in this study and sign an informed consent form.\n\n(2) Follow up stage\n\n1. According to previous studies, a positive rate of 5% -8% was found in subjects with positive M protein screening. Each sub center included approximately 50-80 positive subjects based on actual conditions. At the same time, control subjects with negative M protein testing were matched by age and gender parameter 1:1.\n2. Volunteer to participate in the follow-up phase of the study and sign an informed consent form.\n\nExclusion Criteria:\n\n(1) Screening stage\n\n1\\) Previously diagnosed with hematological diseases such as plasma cell or other B lymphocyte proliferative diseases.\n\nCulling criteria:\n\n1. Samples with incomplete or untraceable subject data.\n2. Unqualified samples: including serum samples with severe hemolysis, fatty blood or jaundice, insufficient sample, and samples not stored as required.\n3. The subject requested to withdraw from the study midway.\n4. Duplicate samples of subjects at the same time point.","30 Years",{"count":129,"type":21},10000,"This study aims to utilize a highly sensitive method for detecting M protein in serum to examine the prevalence of M protein in various age groups of individuals aged over 30 who underwent physical examinations in different regions of China. Furthermore, the study seeks to analyze the relationship between physical examination indicators and the presence of serum M protein (as measured by relative intensity) in the study participants at the time of enrollment. Additionally, a 5-year follow-up period will be employed to observe the association between annual physical examination indicators and clinical outcomes in subjects identified with positive\u002Fnegative serum M protein screening.",[26,29,132],"M-protein",[132],"2025-04-07",{"date":136,"type":39},"2025-04-09",{"date":138,"type":21},"2025-05-01",{"date":140,"type":21},"2029-12-31",{"name":142,"class":46},"Zhujiang Hospital",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":47},"100553709","screening-for-monoclonal-gammopathy-in-individuals-undergoing-physical-examinations-using-ims-lc-assay-technology-100553709","NCT06489613","Screening for Monoclonal Gammopathy in Individuals Undergoing Physical Examinations Using iMS-LC Assay Technology.","Inclusion Criteria:\n\n1. Clinical patients:\n\n   * ≥18 years old;\n   * have concurrent SPEP + SIFE + FLC test results.\n2. Individuals undergoing routine physical examinations:\n\n   * ≥30 years old;\n   * have concurrent SPEP test results.\n\nExclusion Criteria:\n\n* NA",{"count":150,"type":21},15600,"iMS-LC Assay (intact M-protein Screening-Light Chain Assay) is a new technology based on mass spectrometry identification of intact clonal immunoglobulin light chains for the specific detection of M-proteins in peripheral blood.\n\nThe investigators propose to conduct a prospective, single-center observational study to screen for M-proteins in the peripheral blood of individuals undergoing routine physical examinations using iMS-LC Assay technology. The goals of this observational study are : (1) to evaluate the diagnostic efficacy of detecting peripheral blood M-proteins using the iMS-LC Assay method; and (2) to determine the prevalence of MGUS in the population undergoing routine physical examinations based on mass spectrometry screening.\n\nInitially, the investigators will collect clinical patient samples continuously and conduct a diagnostic trial of the iMS-LC Assay, using the clinical methods SPEP + SIFE + FLC as the gold standard. Based on the diagnostic performance of the iMS-LC Assay, the investigators will then screen for M-proteins in continuous samples from individuals undergoing routine physical examinations, to further determine the prevalence of MGUS in this population based on mass spectrometry screening.",[153,26,154],"M Protein","Monoclonal Gammopathy of Undetermined Significance",[156,157],"M protein","Monoclonal gammopathy of unknown significance","2024-07-06",{"date":160,"type":39},"2024-07-09",{"date":162,"type":21},"2024-07",{"date":164,"type":21},"2025-06",{"name":166,"class":46},"Jian Li"]