[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575353":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":19,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":19,"maxAge":19,"enrollmentInfo":38,"targetDuration":19,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":47,"overallStatus":53,"whyStopped":19,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":19},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dara-CyBorD","EXPERIMENTAL","Daratumumab Cyclophosphamide Bortezomib Dexamethasone",[13],"Drug: Dara-CyBorD",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Dara-CyBorD will be used for newly diagnosed PGNMID, OR LCPT, OR TMA OR CGGN.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Yang Liu","CONTACT","86-13716926210","pkuphliuyang@bjmu.edu.cn",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Jin Lu, MD","Dr","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":39,"type":40},10,"ESTIMATED","INTERVENTIONAL",[43],"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.",[46],"Monoclonal Gammopathy of Renal Significance (MGRS)",[48,49,50,51,52],"PGNMIDs","LCPT","TMA","CGGN","daratumumab","NOT_YET_RECRUITING","2025-01-08",{"date":56,"type":57},"2025-01-13","ACTUAL",{"date":59,"type":40},"2025-01-15",{"date":61,"type":40},"2026-06-30",{"name":5,"class":6}]