[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"monoclonal-gammopathy-of-renal-significance-mgrs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:monoclonal-gammopathy-of-renal-significance-mgrs":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100575353","phase-2-dara-bcd-for-rare-mgrs-100575353",false,"NCT06771180","Dara-BCD for Rare MGRS","Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Rare Monoclonal Gammopathies of Renal Significance","Inclusion Criteria:\n\n1. Diagnosis of PGNMIDs, OR LCPT, OR TMA, OR CGGN.\n2. Evidence of clonal plasma cell in bone marrow.\n3. ECOG 0,1,2\n4. Neu≥ 1.0\\*10\\^9\u002FL, HGB ≥70g\u002FL, PLT ≥ 50\\*10\\^9\u002FL.\n5. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;\n6. Informed consent explained to, understood by and signed by the patient.\n\nExclusion Criteria:\n\n1. Prior therapy for MGRS, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)\n2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n3. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n4. Severe or persistent infection that cannot be effectively controlled;\n5. Presence of severe autoimmune diseases or immunodeficiency disease;\n6. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]); Patients with HIV infection or syphilis infection;\n7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.","ALL",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","This is an open-label, multicenter, phase 2 study in subjects with newly diagnosed proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMIDs), OR light chain proximal tubulopathy (LCPT), OR thrombotic Microangiopathy (TMA), OR cryoglobulinemic glomerulonephritis, (CGGN), treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.",[25],"Monoclonal Gammopathy of Renal Significance (MGRS)",[27,28,29,30,31],"PGNMIDs","LCPT","TMA","CGGN","daratumumab","NOT_YET_RECRUITING","2025-01-08",{"date":35,"type":36},"2025-01-13","ACTUAL",{"date":38,"type":19},"2025-01-15",{"date":40,"type":19},"2026-06-30",{"name":42,"class":43},"Peking University People's Hospital","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100461081","a-cohort-study-of-plasma-cell-disorders-pcds-in-pkufh-100461081","NCT05283993","A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH","A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH","Inclusion Criteria:\n\n1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)\n2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).\n3. Patients are included into this cohort after signing the ICFs.\n\nExclusion Criteria:\n\nSignificant comorbidity may be life-threatening.",true,{"count":53,"type":19},2000,"OBSERVATIONAL","The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.",[57,58,59,60,61,62,63,64,65,66,25,67],"Multiple Myeloma","Amyloidosis","Cryoglobulinemia","Castleman's Disease","Light Chain Deposition Disease","Heavy Chain Deposition Disease","Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes","Smoldering Multiple Myeloma","Plasma Cell Leukemia","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Monoclonal Gammopathy of Neurological Significance (MGNS)","RECRUITING","2022-04-21",{"date":71,"type":36},"2022-04-25",{"date":73,"type":36},"2021-07-01",{"date":75,"type":19},"2030-12-31",{"name":77,"class":43},"Peking University First Hospital",1]