[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jin Lu, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"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":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100530914","optimize-first-line-treatment-for-al-amyloidosis-with-t-11-14-100530914",false,"NCT06192979","Optimize First-line Treatment for AL Amyloidosis With t (11; 14)","Optimize First-line Treatment for Systemic Light Chain Amyloidosis With t (11; 14)","Inclusion Criteria:\n\n1. Diagnosis of systemic AL amyloidosis;\n2. Daratumumab, bortezomib, dexamethasone used in 1st line treatment;\n3. Life expectancy greater than 12 weeks;\n4. HGB ≥70g\u002FL;\n5. Blood oxygen saturation \\>90%;\n6. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;\n7. Informed consent explained to, understood by and signed by the patient.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. 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},41,"ESTIMATED","INTERVENTIONAL",[22],"NA","Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.",[25,26],"Amyloidosis; Systemic","AL Amyloidosis",[28,29,30],"t(11;14)","Rapid Response","AL amyloidosis","RECRUITING","2026-03-06",{"date":34,"type":35},"2026-03-09","ACTUAL",{"date":37,"type":35},"2024-01-05",{"date":39,"type":19},"2027-03-31",{"name":41,"class":42},"Jin Lu, MD","OTHER",6,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100542407","phase-2-bortezomib-pomalidomide-dexamethasone-for-systemic-al-amyloidosis-100542407","NCT06342466","Bortezomib, Pomalidomide, Dexamethasone for Systemic AL Amyloidosis","A Study of Bortezomib, Pomalidomide, Dexamethasone in Patients with Systemic AL Amyloidosis","Inclusion Criteria:\n\n1. Diagnosis of AL amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry.\n2. Newly diagnosed or previous treated AL amyloidosis\n3. Patients must be ≥ 18 years of age.\n4. ECOG performance status 0, 1 or 2.\n5. Measurable disease defined by at least one of the following:\n\n   ① serum free light chain (FLC) ≥2.0 mg\u002FdL (20 mg\u002FL) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dFLC) ≥2mg\u002FdL (20 mg\u002FL).\n\n   ②. presence of a monoclonal spike that is ≥5 g\u002Fl.\n6. Symptomatic organ involvement (heart, kidney, liver\u002FGI tract, peripheral nervous system).\n7. Absolute neutrophil count (ANC) ≥1.0 X 10\\^9\u002FL, Hemoglobin ≥70 g\u002FL, Platelets ≥50 X 10\\^9\u002FL\n8. eGFR ≥20 mL\u002Fmin\u002F 1.73 m\\^2\n9. Written informed consent in accordance with local and institutional guidelines.\n10. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n1. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.\n2. Presence of other tumors which is\u002Fare in advanced malignant stage and has\u002Fhave systemic metastasis;\n3. Severe or persistent infection that cannot be effectively controlled;\n4. Presence of severe autoimmune diseases or immunodeficiency disease;\n5. Patients with active hepatitis B or hepatitis C (\\[HBVDNA+\\] or \\[HCVRNA+\\]);\n6. 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.","18 Years","90 Years",{"count":54,"type":19},40,[56],"PHASE2","This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (AL) amyloidosis. Approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. The primary outcome is hematologic very good partial response and complete response rate at 6 months.",[59],"Systemic Amyloidosis","2024-12-25",{"date":62,"type":35},"2024-12-30",{"date":64,"type":35},"2024-05-06",{"date":66,"type":19},"2026-12",{"name":41,"class":42},1,""]