[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"al-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:al-amyloidosis":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,55,82,107,136,171,191,215,238,260,282,304,322,345,367,391,416,436,455,476,497,522,540,563,598],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100590778","evaluation-of-skin-tests-in-biotherapy-allergies-100590778",false,"NCT06971848","Evaluation of Skin Tests in Biotherapy Allergies","ETCABIO","Inclusion Criteria :\n\n* Patient treated with one of the biotherapies under study (Atezolizumab 1200 mg, Nivolumab 480 mg, Obinutuzumab 100 mg, Durvalumab 1500 mg, Pembrolizumab 200 mg, Daratumumab 1800 mg, Cemiplimab 3500 mg) and who has received at least two injections of the biotherapy without suspected allergic side effects.\n* Subjects covered by or having the rights to medical care assurance\n* Written informed consent obtained from subject\n* If applicable, treatment with corticosteroids and H1 antihistamines by systemic route (IV or oral) which may be discontinued at least one week before performing the tests (Inhaled corticosteroids are allowed).\n\nExclusion Criteria:\n\n* Presence of local or diffuse dermatological lesions (e.g., psoriasis, eczema, ...) that could interfere with the interpretation of skin tests.\n* Poor understanding of the French language\n* Pregnancy, breastfeeding\n* Persons in detention by judicial or administrative decision\n* Person admitted to a health or social establishment for purposes other than research\n* Person subject to a legal protection measure",true,"ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","Biotherapies are biological (extracted from an organism or living tissue) or biotechnological drugs used in the treatment of multiple conditions, such as autoimmune inflammatory diseases, cancers, and hematologic diseases. In recent years, these biotherapies have notably emerged in the treatment of cancers and hematologic disorders. As such, most patients with cancers or hematologic diseases will likely receive a biotherapy as part of their care pathway.\n\nThese biotherapies are associated with various side effects, including hypersensitivity or allergic reactions, which are often poorly characterized in clinical trials. These reactions manifest as symptoms without specific dermatologic or allergologic semiology (such as itching, erythema, shortness of breath, sometimes digestive issues, or discomfort, and in some cases, an anaphylactic reaction).\n\nUnlike other treatments, such as antibiotics and neuromuscular blockers, there are currently no guidelines on the concentrations to use in skin tests for biotherapies. We propose conducting prospective clinical research to scientifically establish the concentrations to be used when investigating hypersensitivity to a biotherapy, in line with best practice recommendations for drug skin testing.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck","Melanoma Neoplasms","Small Cell Bronchial Carcinomas","Bronchial Carcinoma","Pleural Mesothelioma","Hodgkin&#39;s Lymphoma","Chronic Lymphocytic Leukemia","Follicular Lymphoma","Myeloma","AL Amyloidosis","Hepatocarcinoma","Colorectal Cancer","Esophageal Squamous Cell Carcinoma","Heart Cancer","Cholangiocarcinoma","Colorectal Adenocarcinoma","RECRUITING","2026-06-17",{"date":46,"type":47},"2026-06-18","ACTUAL",{"date":44,"type":47},{"date":50,"type":21},"2028-07",{"name":52,"class":53},"University Hospital, Angers","OTHER_GOV",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100473967","phase-1-venetoclax-dexamethasone-in-relapsed-andor-refractory-t1114-amyloidosis-100473967","NCT05451771","Venetoclax-Dexamethasone in Relapsed and\u002For Refractory t(11;14) Amyloidosis","An Open-label Phase I\u002FII Trial of Venetoclax-Dexamethasone in Relapsed and\u002For Refractory t(11;14) Systemic Light-Chain Amyloidosis","Inclusion Criteria:\n\n* Age ≥ 18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol, in the investigator's judgment\n* Confirmed diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) on a tissue biopsy\n* Has received ≥1 prior lines of therapy, including an anti-cluster of differentiation 38 (CD 38) monoclonal antibody\n* Participants with a history of autologous hematopoietic cell transplantation must have recovered from any transplant-related toxicities\n* Presence of t(11;14) on FISH at any time since diagnosis (Eligibility must confirmed by FISH testing at Columbia University Irving Medical Center (CUIMC)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Known hypersensitivity to any of the study drugs\n* History of other malignancy that could affect compliance with the protocol or interpretation of results (Patients with a history of curatively treated basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix, breast cancer, or Hodgkin's Lymphoma are generally eligible. Patients with a malignancy that has been treated, but not with curative intent, will be excluded, unless the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment.)\n* Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal)\n* Patients on renal replacement therapy\n* Known GI disease or GI procedure that could interfere with oral absorption (including difficulty swallowing)\n* New York Heart Association (NYHA) Class III or IV heart failure\n* Mayo stage three-B (IIIB) with N-terminal pro-hormone B-type natriuretic peptide (NT-Pro BNP) \\> 8500 pg\u002FmL\n* Prior exposure to anti-apoptotic protein B-cell lymphoma 2 (BCL-2) inhibitors\n* Patients with human immunodeficiency virus (HIV) who are not on highly active antiretroviral therapy (HAART) or those with active hepatitis A, B, or C infection\n* Patients meeting criteria for symptomatic multiple myeloma by one of the following:(a) Lytic lesions on imaging (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, or (c) Bone marrow plasma cell infiltrate of greater than 60%",{"count":63,"type":21},53,[65,66],"PHASE1","PHASE2","The purpose of this study is assess safety, safest dose, and effectiveness of venetoclax in combination with dexamethasone in participants with t(11;14) positive relapsed (comes back) or refractory (did not get better) light chain amyloidosis.",[36],[70,71],"Light Chain Amyloidosis","Protein Misfolding Disorder","2026-06-16",{"date":46,"type":47},{"date":75,"type":47},"2022-10-26",{"date":77,"type":21},"2027-09",{"name":79,"class":80},"Columbia University","OTHER",6,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":54},"100643534","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-teclistamab-in-combination-with-daratumumab-tec-dara-in-newly-diagnosed-multiple-myeloma-with-concurrent-light-chain-amyloidosis-mmal-100643534","NCT07638683","A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL).","A Phase II Study to Evaluate the Efficacy and Safety of Teclistamab in Combination With Daratumumab (Tec-Dara) in Newly Diagnosed Multiple Myeloma With Concurrent Light Chain Amyloidosis (MM+AL)","Inclusion Criteria:\n\n1. Age ≥18 years, any sex\u002Fgender\n2. Diagnosis of multiple myeloma according to IMWG criteria\n3. Histopathologic diagnosis of AL amyloidosis confirmed by:\n\n   * Green birefringence under polarized light microscopy with Congo red staining; AND at least one of the following:\n\n     1. Immunohistochemistry and\u002For immunofluorescence\n     2. Mass spectrometry\n     3. Electron microscopy\u002Fimmunoelectron microscopy\n4. Measurable disease at screening\n5. Newly diagnosed, no prior anti-plasma cell therapy\n6. Adequate laboratory values:\n\n   * Hemoglobin ≥7.5 g\u002FdL\n   * Absolute neutrophil count ≥1.0×10⁹\u002FL\n   * Platelet count ≥70×10⁹\u002FL (platelet transfusion acceptable; \\>50×10⁹\u002FL if ≥50% bone marrow nucleated cells are plasma cells)\n   * ALT ≤2.5× upper limit of normal (ULN)\n   * AST ≤2.5× ULN\n   * Total bilirubin ≤2.0× ULN\n   * Creatinine clearance ≥30 mL\u002Fmin\n   * Corrected serum calcium ≤14 mg\u002FdL\n7. Male and female participants of childbearing potential must use at least 2 effective contraceptive methods during the study\n8. Voluntarily signed informed consent form (ICF)\n\nExclusion Criteria:\n\n1. Prior anti-myeloma therapy or stem cell transplantation\n2. Diagnosis of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, primary AL amyloidosis without concurrent MM, Waldenström macroglobulinemia, plasma cell leukemia, POEMS syndrome, or other malignancies within 3 years prior to enrollment\n3. Active infection or autoimmune disease\n4. Uncontrolled diabetes, hypertension, or other comorbidities\n5. Pregnant or lactating female\n6. Currently participating in another interventional study\n7. Any other condition that the investigator considers unsuitable for study participation",{"count":90,"type":21},30,[66],"The goal of this clinical trial is to learn if teclistamab in combination with daratumumab (Tec-Dara) works to treat newly diagnosed multiple myeloma with concurrent light chain amyloidosis (MM+AL). It will also learn about the safety of this combination. The main questions it aims to answer are:\n\nDoes Tec-Dara improve the 1-year progression-free survival rate compared to historical data (50% to 75%) in MM+AL patients? What are the rates of hematologic response (ORR, VGPR, CR, MRD negativity) and organ response in MM+AL patients treated with Tec-Dara? What medical problems do participants have when taking Tec-Dara?\n\nParticipants will:\n\nReceive teclistamab subcutaneous injection with step-up dosing (0.06, 0.3, 1.5 mg\u002Fkg), followed by 1.5 mg\u002Fkg weekly in Cycle 1, 3.0 mg\u002Fkg every 2 weeks in Cycles 2-3, and 3.0 mg\u002Fkg every 4 weeks in Cycles 4-24 Receive daratumumab subcutaneous injection 1800 mg weekly in Cycles 1-2, every 2 weeks in Cycles 3-6, and every 4 weeks in Cycles 7-24 Continue treatment until disease progression, unacceptable toxicity, or a maximum of 24 cycles Undergo disease assessments every 28 days (±7 days) including laboratory tests for hematologic and organ response evaluation Provide bone marrow samples for MRD and RNA sequencing analysis",[94,36],"Multiple Myeloma",[94,36,96,97],"Teclistamab","Daratumumab","2026-06-04",{"date":100,"type":47},"2026-06-10",{"date":102,"type":21},"2026-05-22",{"date":104,"type":21},"2028-12-30",{"name":106,"class":80},"Shanghai Zhongshan Hospital",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":54},"100640019","early-phase-1-autologous-bcma-targeted-car-t-cell-injection-for-relapsedrefractory-light-chain-amyloidosis-100640019","NCT07626476","Autologous BCMA-targeted CAR-T Cell Injection for Relapsed\u002FRefractory Light Chain Amyloidosis","An Exploratory Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Autologous BCMA-targeted CAR-T Cell Injection in Participants With Relapsed\u002FRefractory Light Chain Amyloidosis","Inclusion Criteria:\n\n* The participant must personally sign an ethics-committee-approved informed consent form before study start.\n* Age ≥18 years.\n* Pathologically confirmed light chain amyloidosis.\n* Relapsed\u002Frefractory light chain amyloidosis previously treated with 2 or more lines of therapy.\n* dFLC \\>50 mg\u002FL.\n* Expected survival ≥12 weeks.\n* ECOG score ≤2.\n* Diagnosis of AL amyloidosis must meet the following conditions: (1) clinical manifestations, physical examination, laboratory or imaging examinations confirm tissue or organ involvement; (2) tissue biopsy pathology confirms amyloid deposition, and the precursor protein of amyloid protein is immunoglobulin light chain or heavy and light chain; and the participant is relapsed\u002Frefractory.\n* Female participants of childbearing potential should agree to use effective contraception from the date of signing informed consent until 365 days after infusion. Effective contraception is defined as abstinence or contraception using methods specified in the protocol with an annual failure rate \\\u003C1%.\n* Adequate organ function before enrollment, meeting all of the following:\n\n  * Absolute neutrophil count ≥1.0×10\\^9\u002FL; granulocyte colony-stimulating factor (G-CSF) support is permitted.\n  * Platelet count ≥50×10\\^9\u002FL.\n  * Hemoglobin ≥8 g\u002FdL.\n  * Bilirubin ≤1.5×upper limit of normal (ULN), except biliary obstruction caused by tumor compression.\n  * ALT or AST ≤2.5×ULN; for participants with liver involvement, ≤5×ULN.\n  * Mayo 2004 stage I-IIIa.\n  * Stable coagulation function: INR ≤1.5 and APTT ≤1.2×ULN, except tumor-related anticoagulant therapy.\n  * Baseline oxygen saturation on room air \\>92%.\n\nExclusion Criteria:\n\n* Participants who have received the following prior treatments:\n\n  * Prior gene therapy before enrollment.\n  * Live vaccine injection within 4 weeks before enrollment.\n  * Other interventional clinical study drug treatment within 12 weeks before leukapheresis.\n* Central nervous system involvement or complete intestinal obstruction.\n* Moderate or higher pleural effusion or ascites that is difficult to control with conventional treatment and requires continuous catheter drainage.\n* Active malignancy within the past 5 years, unless it is a curable tumor and has been clearly cured.\n* HBsAg positivity with abnormal peripheral blood HBV DNA testing; HCV antibody positivity with peripheral blood HCV RNA positivity; HIV antibody positivity; CMV DNA positivity; or positive syphilis RPR test.\n* Uncontrolled active infection, except CTCAE grade \\\u003C2 urogenital infection and upper respiratory tract infection.\n* Severe heart disease, including but not limited to unstable angina, myocardial infarction within 6 months before screening, congestive heart failure (New York Heart Association \\[NYHA\\] class ≥III), positive six-minute walk test, interventricular septum and left ventricular posterior wall thickness \\>1.5 cm, or ventricular arrhythmia and atrioventricular block indicated by ambulatory electrocardiography.\n* Hypertension that cannot be controlled by medication.\n* Toxicity from prior treatment not recovered to baseline or ≤grade 1 according to NCI CTCAE v5.0, except alopecia and clinically insignificant laboratory abnormalities.\n* Major surgery within 2 weeks before enrollment, or planned surgery during the waiting period before infusion or within 12 weeks after study treatment, except planned local anesthesia surgery.\n* Solid organ transplantation.\n* Pregnant or breastfeeding women.\n* History of central nervous system disease, such as cerebral aneurysm, epilepsy, stroke, senile dementia or psychiatric disease, or disturbance of consciousness.\n* Other systemic disease judged unstable by the investigator, including but not limited to severe hepatic, renal or metabolic disease requiring medication.\n* Known life-threatening allergic reaction, hypersensitivity or intolerance to the CAR-T cell product or its components.\n* Bleeding or severe thrombosis as judged by the investigator, hereditary\u002Facquired bleeding or severe thrombosis, including hemophilia, coagulopathy, thrombocytopenia and hypersplenism, or current thrombolytic or anticoagulant therapy.\n* Other conditions that the investigator considers unsuitable for enrollment.",{"count":90,"type":21},[116],"EARLY_PHASE1","Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed\u002Frefractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended.\n\nThis study evaluates targeted BCMA autologous CART cell injection in participants with relapsed\u002Frefractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.",[119,36,120],"Relapsed\u002FRefractory Light Chain Amyloidosis","Systemic Light Chain Amyloidosis",[122,123,124,125,126,127],"AL amyloidosis","light chain amyloidosis","relapsed\u002Frefractory","BCMA","CAR-T","autologous CAR-T","2026-05-29",{"date":98,"type":47},{"date":131,"type":47},"2024-12-16",{"date":133,"type":21},"2029-12-15",{"name":135,"class":80},"Beijing Boren Hospital",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":54},"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",{"count":145,"type":21},50,[24],"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)",[149,150,94,36,151],"Monoclonal Gammopathy","Monoclonal Gammopathy of Undetermined Significance (MGUS)","Systemic Amyloidosis",[153,154,155,156,157,158,159,160,122],"MGUS","MGCS","Amyloid PET","PET\u002FMRI","Florbetaben","Early detection","Systemic amyloidosis","Monoclonal gammopathy","NOT_YET_RECRUITING","2026-05-28",{"date":164,"type":47},"2026-06-03",{"date":166,"type":21},"2026-10",{"date":168,"type":21},"2028-05",{"name":170,"class":80},"University of Zurich",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":189,"locationsCount":54},"100639800","early-phase-1-a-pilot-study-of-anselamimab-in-patients-with-al-amyloidoma-and-measurable-tissue-involvement-100639800","NCT07615270","A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement","A Pilot Study of CAEL-101\u002FAnselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement","Inclusion Criteria:\n\n1. AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry\n2. Amyloid deposits are measurable by imaging (ultrasound or cross-sectional)\n3. 18 years or older\n4. ECOG performance status 0-3\n5. Adequate bone marrow reserve, hepatic and renal function as demonstrated by:\n\n   1. Absolute neutrophil count ≥ 1.0 × 109\u002FL\n   2. Platelet count ≥ 75 × 109\u002FL\n   3. Hemoglobin ≥ 9 g\u002FdL\n   4. Total bilirubin ≤ 2 times the upper limit of normal (× ULN) unless due to Gilbert's syndrome.\n   5. Aspartate aminotransferase (AST) ≤ 3 × ULN\n   6. Alanine aminotransferase (ALT) ≤ 3 × ULN\n6. No evidence of cardiac, renal or hepatic involvement by amyloidosis\n\n   1. Echocardiogram with mean wall thickness \\\u003C\u002F= 12mm unless other cardiac cause\n   2. 24 hour urine protein \\\u003C500mg AND estimated glomerular filtration rate (eGFR) \\>50mL\u002Fmin\u002F1.73 sqm (Cockcroft-Gault formula)\n   3. Alkaline phosphatase below upper limit of normal and total liver span \\\u003C\u002F=15cm\n7. Participants of childbearing potential agree to use contraception throughout study an\n8. Ability to understand and willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Use of other investigational agents within 30 days of screening\n2. Taking doxycycline within 30 days of screening\n3. Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder.\n4. Major surgery within 4 weeks of enrollment\n5. Pregnant\n6. Breast feeding\n7. Participant is eligible and agreeable to standard of care chemotherapy.\n8. Presence of active infection at the time of screening\n9. Participant with a monoclonal protein or isotypic light chain predominance (increased level of the involved light chain and abnormal free light chain ratio (\\\u003C0.26 or \\>1.65)) ☐\n\n   ☐\n10. Participant with known or suspected systemic AL amyloidosis, or suspicion of other organ involvement.\n11. Lymph node involvement\n12. Involvement of amyloidoma in more than one organ.\n13. AL amyloidoma involving other disease locations except those specified in the protocol\n14. Presence of solitary plasmacytoma\n15. Participant with clinically significant lung disorder or disease\n16. Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.",{"count":179,"type":21},5,[116],"This is an exploratory study to assess the binding of CAEL-101\u002Fanselamimab to amyloid in vivo, recruitment of inflammatory cells and reduction of the amyloid mass.",[36],[184],"Anselamimab",{"date":128,"type":47},{"date":187,"type":21},"2026-07",{"date":50,"type":21},{"name":190,"class":80},"Stanford University",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":214},"100517853","phase-3-comparing-dara-vcd-chemotherapy-plus-stem-cell-transplant-to-dara-vcd-chemotherapy-alone-for-people-who-have-newly-diagnosed-al-amyloidosis-100517853","NCT06022939","Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis","A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloidosis","Inclusion Criteria:\n\n* STEP 1: Participants must have systemic AL amyloidosis which is biopsy proven and includes histologically-confirmed by positive Congo red stain with green birefringence on polarized light microscopy, OR characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence). If there is question regarding diagnosis, consult study chairs prior to registration\n* STEP 1: Participants must have measurable disease within 28 days prior to treatment if initiated prior to registration or within 28 days of registration as defined by at least one of the following:\n\n  * Positive monoclonal serum immunofixation electrophoresis\n  * Positive monoclonal urine immunofixation electrophoresis\n  * Monoclonal plasma cells in bone marrow In addition, participants must also have a difference between the involved and uninvolved free light chain (dFLC) \\>= 2 mg\u002FdL\n* STEP 1: Participants may receive up to one cycle (or 28 days) of therapy prior to enrollment. If a patient receives \\>= 75% of 1 cycle of protocol identical Dara-VCD, this will be considered 1 cycle of protocol induction. Any patient who receives less than 75% of 1 cycle of Dara-VCD or non-protocol therapy will still be eligible but will be treated per protocol. If protocol identical therapy is initiated prior to enrollment, this treatment is not continued but rather treatment is dictated per protocol\n* STEP 1: Participants may be receiving chronic corticosteroids if they are being given for disorders other than AL amyloidosis or myeloma\n* STEP 1: Participant must be \\>= 18 years old\n* STEP 1: Participant must have Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)\n* STEP 1: Participant must have a complete medical history and physical exam within 28 DAYS prior to registration\n* STEP 1: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are randomized to the arm receiving high dose chemotherapy and autologous stem cell transplantation\n* STEP 1: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg\u002Fm\\^2 or 140 mg\u002Fm\\^2 (200 mg\u002Fm\\^2 is highly encouraged but not mandated). Transplant eligibility criteria are included in the general eligibility criteria listed below:\n\n  * Participant must have a supine systolic blood pressure (BP) \\>= 90 mmHg (at registration step-1, this may by supported by midodrine\n  * Participant must have non-severe cardiac AL (meeting all the below criteria) as defined by:\n\n    * N-terminal proB-type natriuretic peptide (NT proBNP) \\\u003C 5000 (if no NTproBNP, brain natriuretic peptide \\[BNP\\] must be available and \\\u003C 400)\n    * Troponin T (TnT) \\\u003C 0.06. If not available, one of the following two criteria must be met:\n\n      * High sensitivity troponin (hsTnT) T \\\u003C 75 or troponin I \\\u003C 0.1ng\u002FdL\n    * New York Heart Association (NYHA) I or II\n    * Cardiac ejection fraction (EF) \\>= 40%\n* STEP 1: Hemoglobin \\>= 8.0 g\u002FdL (\\> 5 mmol\u002FL); red blood cell transfusion allowed up to 7 day prior to registration (within 28 days prior to registration) (NOTE: Growth factor support granulocyte colony-stimulating factor \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Leukocytes \\>= 2 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Platelets \\>= 50 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 1: Total bilirubin =\\\u003C 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* STEP 1: Direct bilirubin =\\\u003C 2.0 mg\u002FdL (within 28 days prior to registration)\n* STEP 1: Aspartate aminotransferase (AST)\u002F alanine aminotransferase (ALT) =\\\u003C 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 1: Alkaline phosphatase =\\\u003C 750 U\u002FL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 1: Participants must have a serum creatinine =\\\u003C the institutional (I)ULN OR measured OR calculated creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to registration\n* STEP 1: If peripheral neuropathy is present at diagnosis, participants must be grade 2 (moderate symptoms; limiting instrumental activity of daily living \\[ADL\\]) or less\n* STEP 1: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better\n* STEP 1: Participants must not be seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR\n* STEP 1: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* STEP 1: Participants must not have concurrent multiple myeloma as defined by the presence of lytic bone disease, plasmacytomas, \\>= 60% plasma cells in the bone marrow, or hypercalcemia. Participants will not be excluded solely based on the presence of plasma cells \\> 10% in the bone marrow unless the plasma cell percentage exceeds \\>60%\n* STEP 1: Participants must not have known allergies to any of the study drugs\n* STEP 1: Participants must not have had a major surgery within 14 days prior to registration and be fully recovered from surgery completed within 14 days prior to registration\n* STEP 1: Participants must not have a known chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \\\u003C 50% of predicted normal\n* STEP 1: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* STEP 1: Participants must not have either moderate or severe persistent asthma within the past 2 years), or currently have uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study)\n* STEP 1: Participants must not have uncontrolled diabetes within 28 days prior to registration\n* STEP 1: Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration. Participants must have a supine systolic BP of \\>= 90 mmHg\n* STEP 1: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* STEP 1: Participants must not have received vaccination with live attenuated vaccines within 28 days prior to Registration to Step 1\n* STEP 1: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment\n* STEP 1: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* STEP 1: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwestern Oncology group (SWOG) Specimen Tracking System\n* STEP 1: Participants must agree to have blood, bone marrow core biopsy and aspirate, and fat pad biopsy specimens submitted for minimal residual disease assessment and future exploratory studies\n* STEP 1: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life\n* STEP 2: Participants must have met all eligibility criteria for Step-1 registration\n* STEP 2: Participants must have achieved at least a partial response\n* STEP 2: Participants must continue receiving at least one of study drugs (bortezomib, cyclophosphamide, or daratumumab and hyaluronidase-fihj) if another study drug (daratumumab and hyaluronidase-fihj, cyclophosphamide, or bortezomib) has been discontinued due to adverse events. Note: daratumumab and hyaluronidase-fihj cannot be permanently discontinued\n* STEP 2: Participants must have completed induction therapy\n* STEP 2: Participants must be registered to Step 2 within 42 days of cycle 3, day 28 of induction therapy\n* STEP 2: Participants must plan to initiate their assigned consolidation therapy within 8 weeks after randomization\n* STEP 2: Participants must not have experienced a MOD-PFS event\n* STEP 2: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 may be allowed if secondary to neuropathy)\n* STEP 2: Participant must have a complete medical history and physical exam within 28 days prior to registration\n* STEP 2: Participants must be willing to undergo high dose chemotherapy and autologous stem cell transplantation if they are randomized to the arm receiving high dose chemotherapy and autologous stem cell transplantation\n* STEP 2: Participants randomized to Arm 2 must be willing and able to return to a participating treatment center for their assigned treatment after transplant. Note that participants need not to have a direct relationship with the transplant center in order to register\n* STEP 2: Participants must be eligible to receive high dose chemotherapy with melphalan at a dose of 200 mg\u002Fm\\^2 or 140 mg\u002Fm\\^2 (200 mg\u002Fm\\^2 is highly encouraged but not mandated). Transplant eligibility criteria are included in the general eligibility criteria listed below:\n\n  * Patient must have a supine systolic BP \\>= 90 mmHg (at registration step-1, this may not by supported by midodrine)\n  * Patient must have non-severe cardiac AL as defined by:\n\n    * NT proBNP \\\u003C5000 (if no NTproBNP, BNP must be available and \\\u003C 400 pg\u002FmL) (within 14 days prior to registration step-2)\n    * TnT \\\u003C 0.06. If not available, one of the following two criteria must be met (within 14 days prior to registration step-2)\n\n      * hsTnT \\\u003C75 or troponin I \\\u003C 0.1ng\u002FdL\n    * NYHA I or II (within 14 days prior to registration step-2)\n    * Cardiac EF \\>= 40% (within 14 days prior to registration step-2)\n* STEP 2: Hemoglobin \\> 8.0 g\u002FdL (\\> 5 mmol\u002FL); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Leukocytes \\>= 2 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Platelets \\>= 50 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 2: Total bilirubin =\\\u003C 1.5 times the institutional ULN unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* STEP 2: Direct bilirubin =\\\u003C 2.0 mg\u002FdL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 2: AST\u002FALT =\\\u003C 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 2: Alkaline phosphatase =\\\u003C 750 U\u002FL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 2: Participants must have a serum creatinine =\\\u003C the IULN OR calculated creatinine clearance ≥ 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* STEP 2: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment\n* STEP 2: Participants randomized to the ASCT arm must be able to have at least 2.0 x 10\\^6 CD34 cells\u002Fkg collected\n* STEP 2: Participants who can complete PRO, QOL, PRO-CTCAE questionnaires, etc. forms in English, Spanish and French must participate in the patient-reported outcomes and quality of life\n* STEP 3: Participants must have met all eligibility criteria for Step-1 and Step-2 registration\n* STEP 3: Participants must not have had daratumumab and hyaluronidase-fihj permanently discontinued during induction or consolidation\n* STEP 3: Participants must have completed induction and consolidation therapy\n* STEP 3: Participants must be registered to Step 3 within the following time frames:\n\n  * If randomized to Arm 1 Dara-VCD consolidation: within 28 days of completion of 3 cycles of consolidation therapy\n  * If randomized to Arm 2 high dose chemotherapy and autologous stem cell transplantation: within 180 days following initiation of stem cell transplantation\n* STEP 3: Participants must not have experienced a MOD-PFS event\n* STEP 3: Participants must have ECOG performance score (PS) of 0, 1, or 2 (PS = 3 is allowed if secondary to neuropathy)\n* STEP 3: Participants must have a complete medical history and physical exam within 28 DAYS prior to registration\n* STEP 3: Hemoglobin \\> 8.0 g\u002FdL (\\> 5 mmol\u002FL); red blood cell transfusion allowed up to 7 days prior to registration (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Leukocytes \\>= 2 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Platelets \\>= 50 x 10\\^3\u002FuL (within 28 days prior to registration) (NOTE: Growth factor support \\[G-CSF\\] is permitted per institutional guidelines)\n* STEP 3: Total bilirubin =\\\u003C 1.5 times the institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\\u003C 5 x institutional ULN (within 28 days prior to registration)\n* STEP 3: Direct bilirubin =\\\u003C 2.0 mg\u002FdL (within 28 days prior to registration)\n* STEP 3: AST\u002FALT =\\\u003C 3x upper limit of normal (ULN) (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 3: Alkaline phosphatase =\\\u003C 750 U\u002FL (except if secondary to hepatic involvement) (within 28 days prior to registration)\n* STEP 3: Participants must not have uncontrolled infection at the discretion of the enrolling physician and to be discussed with the study chair if the participant is on active anti-infectious therapy. Any patient on active anti-microbial therapy for chronic infectious issues should be discussed with the study chair prior to enrollment\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\nFor participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":199,"type":21},338,[201],"PHASE3","This phase III trial compares the effect of adding a stem cell transplant with melphalan after completing chemotherapy with daratumumab, cyclophosphamide, bortezomib and dexamethasone (Dara-VCD) versus chemotherapy with Dara-VCD alone for treating patients with newly diagnosed amyloid light chain (AL) amyloidosis. Melphalan is a chemotherapy given prior to a stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. The stem cells are then returned to the patients to replace the blood forming cells that were destroyed by the chemotherapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs, such as cyclophosphamide and bortezomib, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dexamethasone is in a class of medications called corticosteroids. It is used to lower the body's immune response to help stop the growth of cancer cells. Giving a stem cell transplant with melphalan after Dara-VCD may kill more cancer cells in patients with newly diagnosed AL amyloidosis.",[36],"2026-05-04",{"date":206,"type":47},"2026-05-06",{"date":208,"type":47},"2024-07-01",{"date":210,"type":21},"2030-10-29",{"name":212,"class":213},"SWOG Cancer Research Network","NETWORK",117,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100450463","phase-1-phase-12a-study-of-belantamab-mafodotin-in-relapsed-or-refractory-al-amyloidosis-100450463","NCT05145816","Phase 1\u002F2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis","A Dose-Finding and Proof-of-Concept Phase 1\u002F2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis","Inclusion Criteria:\n\n1. Participants medically diagnosed with relapsed or refractory Amyloid Light Chain Amyloidosis (AL amyloidosis) with one or more line of treatment as below:\n\n   1. Must have received a proteosome inhibitor, alkylator and anti-cluster of differentiation 38 (CD38) antibody (e.g., daratumumab - for patients who were eligible to receive in newly diagnosed AL Amyloidosis) and autologous stem cell transplant (for transplant eligible candidates).\n\n      OR\n   2. Failed treatment and\u002For intolerant\u002Fineligible for above agents\n\n   NOTE: Patients who fail to achieve Partial Hematological Response or better after 2 cycles of induction therapy for newly diagnosed AL Amyloidosis are also eligible.\n2. Participant must be over 18 years of age inclusive, at the time of signing the informed consent.\n3. Participant and Disease Characteristics: Patient must have primary systemic AL amyloidosis, histologically confirmed at the initial diagnosis before initiation of 1st-line treatment by positive Congo red stain with green birefringence on polarized light microscopy, Or characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence).\n4. Patient must have measurable disease within 28 days prior to registration; serum quantitative immunoglobulins (immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM), serum free kappa and lambda, and serum protein electrophoresis (SPEP) with M-protein quantification must be obtained within 14 days prior to registration.\n5. Measurable disease of amyloid light chain amyloidosis as defined by at least One of the following:\n\n   a. Serum M-protein ≥0.5 g\u002FdL by protein electrophoresis (routine serum protein electrophoresis and immunofixation).\n\n   b. Serum free light chain ≥50 mg\u002FL with an abnormal kappa: lambda ratio or the difference between the involved and uninvolved free light chains (dFLC) ≥50 mg\u002FL.\n6. One or more organs impacted by AL Amyloidosis according to consensus guidelines below per National Comprehensive Cancer Network (NCCN)Guidelines Version 1.2016:\n\n   a. Cardiac Involvement i. Mean left ventricular wall thickness on echocardiogram greater than or equal to 12 mm in the absence of hypertension or valvular heart disease, OR N-terminal fragment brain natriuretic protein (NT-pro) brain natriuretic peptide (BNP) greater than 332 ng\u002FmL provided that patient does not have impaired renal function (as defined by calculated creatinine clearance less than 25 mL\u002Fmin) within 14 days prior to registration, OR prior cardiac biopsy (at time of diagnosis) showing amyloid deposition with past documented or presently noted clinical symptoms and signs supportive of a diagnosis of heart failure in the absence of an alternative explanation for heart failure.\n\n   b. Non-Cardiac Organ Involvement\n\n   i. Kidney: albuminuria greater than or equal to 500 mg per day on a 24-hour urine specimen within 35 days prior to registration, OR prior kidney biopsy (at the time of diagnosis) showing amyloid deposition.\n\n   ii. Liver: hepatomegaly (total liver span \\> 15 cm) as demonstrated by computed tomography (CT) or magnetic resonance imaging (MRI) within 35 days prior to registration OR alkaline phosphatase (ALP) greater than 1.5 times the institutional upper limit of normal within 14 days prior to registration, OR prior liver biopsy (at the time of diagnosis) showing amyloid deposition.\n\n   iii. Gastrointestinal tract: direct biopsy verification with symptoms.\n\n   iv. Lung: biopsy verifications with symptoms and interstitial radiographic pattern.\n\n   v. Soft tissue: tongue enlargement, clinical, arthropathy, claudication, presumed vascular amyloid, skin involvement, carpal tunnel syndrome, myopathy by biopsy or pseudohypertrophy.\n7. Patients must have completed other systemic therapy or investigational drug ≥ 28 days or five half-lives prior to registration, surgery (other than biopsies) ≥ 28 days prior to registration, and any autologous stem cell transplant (ASCT) ≥ 100 days prior to registration.\n8. Patients must have a complete medical history and physical exam within 14 days prior to registration.\n9. New York Heart Association (NYHA) Class 1 - 3a which has been clinically stable for 56 days before registration\n10. Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2\n11. Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) \\> 35% within 28 days prior to registration.\n12. Adequate organ system functions within 14 days of registration as defined by the laboratory assessments below:\n\n    a) Hematologic i) Absolute neutrophil count (ANC): ≥1.0 × 10(9)\u002F L \\* ii) Hemoglobin: ≥8.0 g\u002FdL \\* iii) Platelets: ≥50 × 10(9)\u002FL \\*\n\n    b) Hepatic i) Total bilirubin: ≤1.5 × upper limit of normal (ULN); (Isolated bilirubin ≥1.5 × ULN is acceptable if bilirubin is fractionated, and direct bilirubin is \\\u003C35%) ii) Alanine aminotransferase (ALT): ≤2.5 × ULN\n\n    c) Renal i) Estimated glomerular rate (eGFRª): ≥30 mL\u002Fmin\u002F1.73 m2 Note: Laboratory results obtained during Screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the participant and the subsequent within range screening result may be used to confirm eligibility.\n\n    \\* Without growth factor or cell transfusion support for the past 14 days prior to testing, excluding erythropoietin.\n\n    ª As calculated by Modified Diet in Renal Disease (MDRD) formula (Appendix 4 in Protocol)\n13. Females of childbearing potential: These participants must have a negative baseline pregnancy test using serum or urine within 14 days prior to starting therapy and a confirmatory negative serum pregnancy test with a sensitivity of at least 50 mIU\u002FmL within 72 hours prior to registration; females of childbearing potential must also agree:\n\n(1) to have a pregnancy test prior to the start of each treatment cycle and (2) to either commit to continued abstinence from heterosexual intercourse or to use effective contraception while receiving study drug and for at least 4 months after receiving the last dose of study drug; females are considered to be of childbearing potential if they have had menses at any time in the preceding 24 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures.\n\n1. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), preferably with low user dependency (as described in Appendix 9), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.\n2. A WOCBP must have a negative serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention.\n3. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy.\n4. Non-childbearing potential is defined as follows (by other than medical reasons):\n\ni. ≥45 years of age and has not had menses for \\>1 year.\n\nii. Patients who have been amenorrhoeic for \\\u003C2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation.\n\niii. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure.\n\n14\\. Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm:\n\n1. Refrain from donating sperm\n\n   Plus, either:\n2. be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent\n\n   Or\n3. agree to use a barrier method of birth control (e.g., male condom), even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \\\u003C1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females).\n\n   15\\. Patients with Human Immunodeficiency Virus (HIV) infection are eligible if:\n\na. patients without a history of Acquired Immune Deficiency Syndrome (AIDS)-defining opportunistic infections\n\nb. patients with a history of AIDS-defining opportunistic infection may be eligible if they have not had an opportunistic infection within past 12 months.\n\nc. Patients on active anti-retroviral therapy are eligible as long as anti-retroviral therapy is established for at least four weeks and have HIV viral load less than 400 copies\u002Fml prior to enrollment.\n\n16\\. Patients with chronic Hepatitis B Virus (HBV) infection or chronic Hepatitis C Virus (HCV) infection or virologically suppressed on HCV treatment are eligible if:\n\n1. Hepatitis B surface antigen (HBsAg)-negative, anti-Hemoglobin C (HBc)-positive patients are at lower risk of HBV reactivation compared with HBsAg-positive patients, risk of HBV reactivation should be considered in all patients and if patients can be on anti-HBV prophylaxis prior to initiation of anti-cancer therapy.\n2. Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy.\n3. Patients actively on treatment for HCV should have HCV below the limit of quantification before initiation of anti-cancer therapy.\n4. Patients who are HCV antibody (Ab) positive but HCV Ribonucleic Acid (RNA) negative due to prior treatment or natural resolution of infection are eligible.\n\nExclusion Criteria:\n\n1. Patients previously treated for active symptomatic multiple myeloma.\n2. Any corneal disease except for mild epithelial punctate keratopathy.\n3. Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment.\n4. Patients eligible for autologous stem cell transplantation (ASCT).\n5. Evidence of significant cardiovascular condition as specified below:\n\n   1. N-terminal-prohormone of brain natriuretic peptide (NT-proBNP) ≥ 8500ng\u002FL within 14 days of registration.\n   2. New York Heart Association (NYHA) classification IIIB (3b) through IV (4) heart failure\n   3. Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram (ECG) changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy\n   4. Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening\n   5. Subjects with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker\u002Fimplantable cardioverter-defibrillator (ICD) is indicated but not placed (Subjects who do have a pacemaker\u002FICD are allowed on study)\n   6. Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) \\> 500 msec. Subjects who have a pacemaker may be included regardless of calculated QTc interval\n   7. Symptomatic, clinically significant autonomic neuropathy which the Investigator feels will preclude administration of study treatment\n   8. Acute coronary syndrome, or any form of coronary revascularization procedure including coronary artery bypass grafting (CABG), within 6 months of screening\n   9. Prior solid organ transplant, or anticipated to undergo solid organ transplantation, or requiring left ventricular assist device (LVAD) implantation, during the course of the study\n   10. Stroke within 6 months of screening, or transient ischemic attack (TIA) within 3 months of screening\n   11. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block\n   12. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening\n   13. Uncontrolled hypertension\n6. Prior history of malignancy with the exception of the following: adequately treated basal cell or squamous cell skin cancer, curatively treated non-melanoma skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years.\n7. Presence of any comorbid or uncontrolled medical condition (e.g. uncontrolled hypertension) - defined as defined as an average SBP ≥ 160mm Hg or diastolic ≥ 100mm Hg despite optimal treatment) at screening, which in the opinion of the investigator would increase the potential risk to the subject.\n8. Unwillingness or inability to follow the procedures outlined in the protocol.\n9. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or five half-lives, whichever is shorter, before Cycle 1 Day 1.\n10. Participant must not use contact lenses while participating in this study.\n11. Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment.\n12. Participant must not have any evidence of active mucosal or internal bleeding.\n13. Participant must not have any serious and\u002For unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.\n14. Participants must not be pregnant or lactating.\n15. Participant must not be simultaneously enrolled in any interventional clinical trial.\n16. Participant must not have an active infection requiring treatment.\n17. Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.",{"count":223,"type":21},37,[65,66],"The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug.\n\nThe study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1",[36,227],"Amyloidosis","2026-05-01",{"date":230,"type":47},"2026-05-07",{"date":232,"type":47},"2024-02-15",{"date":234,"type":21},"2027-09-01",{"name":236,"class":80},"University of Texas Southwestern Medical Center",3,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":54},"100627461","one-gene-two-diseases-the-pathologic-role-of-iglv1-44-in-al-amyloidosis-and-poems-100627461","NCT07448935","One Gene, Two Diseases: the Pathologic Role of IGLV1-44 in AL Amyloidosis and POEMS","ALPS","Inclusion Criteria:\n\n* Biopsy-proven diagnosis of systemic AL amyloidosis, POEMS syndrome or multiple myeloma\n* Planned peripheral blood sampling +\u002F- bone marrow aspiration\n* Age \\> 18 years\n* Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent.\n\nExclusion Criteria:\n\n* Undefined monoclonal gammopathy or non-AL amyloidosis\n* Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy\n* Age \\\u003C18 years\n* Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.","99 Years",{"count":247,"type":21},100,"OBSERVATIONAL","By detailed sequence analysis and subsequent biophysical characterization of prototypic light chains, this project aims to identify sequence fingerprints in IGLV1-44 light chains leading to AL amyloidosis and POEMS syndrome. This understanding might help improve the risk stratification and early diagnosis of patients overexpressing pathologic IGLV1-44 LCs. Moreover, the development of nanobodies efficient in recognizing and stabilizing IGLV1-44 light chains which exert direct toxicity in cardiac AL amyloidosis and POEMS syndrome might form the basis for future development of therapeutic agents capable of counteracting IGLV1-44 light chain proteotoxicity.",[36,251,94],"POEMS Syndrome","2026-04-30",{"date":206,"type":47},{"date":255,"type":47},"2025-11-28",{"date":257,"type":21},"2026-06-30",{"name":259,"class":80},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":267,"briefSummary":268,"conditions":269,"keywords":270,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100566016","phase-2-a-phase-ii-trial-of-teclistamab-in-participants-with-previously-treated-immunoglobulin-light-chain-al-amyloidosis-100566016","NCT06649695","A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis","Inclusion Criteria:\n\n* Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry\u002F immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.\n* Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry\u002F immunofluorescence\u002F immunoelectron microscopy\u002F mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2\n* Mayo stage I-IIIA cardiac disease at Screening\n* Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.\n* Measurable hematologic disease: a dFLC \\>20 mg\u002FL with an abnormal κ\u002Fλ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g\u002FdL.\n* Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:\n* Absolute neutrophils ≥1,000\u002Fmm3,\n* Platelets ≥75,000\u002Fmm3,\n* Hemoglobin ≥8.5 g\u002FdL.\n* Adequate organ function, defined as:\n* Serum creatinine clearance (CKD-EPI formula) ≥20 mL\u002Fmin,\n* Serum SGPT\u002FALT \\\u003C5.0 x Upper Limit of Normal (ULN),\n* Serum total bilirubin \\\u003C2.0 mg\u002FdL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be \\\u003C2.0 mg\u002FdL,\n* Serum albumin ≥\\\u003C2.5 gr\u002Fdl (medication to correct serum albumin levels is permitted).\n\nExclusion Criteria:\n\n* Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.\n* Isolated soft-tissue involvement.\n* Presence of non-AL amyloidosis.\n* Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).\n* Intolerance to dexamethasone that would prohibit treatment with trial therapy.\n* MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.\n\nNote: A MM diagnosis with a serum FLC ratio \\>100, as the only myeloma-defining event, does NOT constitute an exclusion.\n\n* All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.\n* Mayo stage IIIB cardiac disease at Screening",{"count":90,"type":21},[66],"This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab",[36],[271],"teclistamab","2026-04-20",{"date":274,"type":47},"2026-04-21",{"date":276,"type":47},"2025-07-02",{"date":278,"type":21},"2028-09",{"name":280,"class":213},"European Myeloma Network B.V.",10,{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":289,"targetDuration":291,"studyType":248,"phases":4,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":303},"100545533","promoting-diagnosis-and-management-of-al-in-italy-prodigality-100545533","NCT06383143","Promoting Diagnosis and Management of AL in Italy (ProDigALIty)","ProDigALIty","PART A\n\nInclusion Criteria:\n\n* diagnosis of MGUS with altered FLCR or SMM;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* Diagnosis of symptomatic monoclonal gammopathies;\n* Previous treatment for monoclonal gammopathies.\n\nPART B\n\nInclusion criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.",{"count":290,"type":21},760,"2 Years","The investigators plan to establish a dedicated network of Italian Hematologic Departments interconnected with the Amyloidosis Research and Treatment Center in Pavia to:\n\n1. Implement a biomarker-based screening strategy to promote early diagnosis of AL amyloidosis among at-risk patients, including patients with monoclonal gammopathy of undetermined significance, MGUS, and altered free light chain ratio (aFLCR), and patients with smoldering multiple myeloma (SMM)\n2. Expedite and facilitate patients' referral and their enrollment in ongoing pre-clinical\u002Fclinical studies, also to reflect a broader spectrum of the real-world population of patients with AL amyloidosis in Italy;\n3. Investigate the clinical utility of novel diagnostic technologies, including light chain sequencing and N-glycosylation analysis",[36,294,295],"Smoldering Multiple Myeloma","Monoclonal Gammopathy of Undetermined Significance","2026-04-13",{"date":298,"type":47},"2026-04-16",{"date":300,"type":47},"2023-05-01",{"date":228,"type":21},{"name":259,"class":80},4,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":312,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":314,"conditions":315,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":316,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":81},"100531911","a-european-registry-and-sample-sharing-network-to-promote-the-diagnosis-and-management-of-light-chain-amyloidosis-eureka-100531911","NCT06205953","A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)","Bonding Molecular Genotyping and Phenotyping to Outcome Measures in AL Amyloidosis: A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)","EUREKA","Inclusion Criteria:\n\n* diagnosis of systemic AL amyloidosis;\n* treatment-naïve;\n* age ≥18 years;\n* ability to understand and willingness to sign an informed consent;\n* planned follow-up at participating center.\n\nExclusion Criteria:\n\n* non-AL amyloidosis;\n* previous treatment for AL amyloidosis.",{"count":313,"type":21},400,"A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.",[36],{"date":298,"type":47},{"date":318,"type":47},"2024-01-01",{"date":320,"type":21},"2026-06-01",{"name":259,"class":80},{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":330,"targetDuration":332,"studyType":248,"phases":4,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":339,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":54},"100426899","a-registry-of-al-amyloidosis-real-100426899","NCT04839003","A Registry of AL Amyloidosis (ReAL)","A Registry to Investigate Real-world Natural History, Impact of Therapies and Patterns of Progression of AL Amyloidosis (ReAL)","ReAL","Inclusion Criteria:\n\n1. diagnosis of systemic AL amyloidosis;\n2. treatment-naïve (pre-treatment data collected at participating center available for retrospective part);\n3. age ≥18 years;\n4. ability to understand and willingness to sign an informed consent (patients who already sign informed consent for clinical data to be used in retrospective analyses will be accepted);\n5. planned (or ongoing) follow-up at participating center.\n\nExclusion Criteria:\n\n1. non-AL amyloidosis;\n2. previous treatment for AL amyloidosis.",{"count":331,"type":21},5000,"5 Years","The purpose of this protocol is to generate a large registry of patients with AL amyloidosis.",[36],[336,337,338],"amyloidosis","prognosis","registry",{"date":298,"type":47},{"date":341,"type":47},"2020-02-27",{"date":343,"type":21},"2027-05",{"name":259,"class":80},{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":22,"phases":354,"briefSummary":355,"conditions":356,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":366},"100508302","phase-2-daratumumab-maintenance-therapy-for-improving-survival-in-patients-with-light-chain-amyloidosis-emilia-trial-100508302","NCT05898646","Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial","Phase II Study Evaluating Maintenance in Light Chain Amyloidosis (EMILIA)","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histological confirmation of AL amyloidosis with adequate typing (mass spectrometry, immunohistochemistry, immunofluorescence, immunogold)\n* AL amyloidosis with organ disease requiring therapy\n\n  * NOTE: Disease requiring therapy is referred to the time of diagnosis. There are no limitations in baseline measurable disease parameters\n* Patients must have monoclonal protein studies (serum free light chain assay, serum immunofixation or serum MASS-FIX) obtained at time of diagnosis before induction therapy initiated and available for review to be enrolled.\n\n  * NOTE: Patients are allowed to participate in this study if urine electrophoresis immunofixation study was not done at time of diagnosis or cannot be obtained\n* Patients must have completed 6 cycles of daratumumab (Dara)-CyBorD-based induction treatment prior to registration or have a plan to complete cycle 6 prior to cycle 1 day 1. NOTE: treatment in the study is allowed only after the completion of 6 cycles of induction\n* Patients must have achieved a hematological complete response (CR) (irrespective of organ response achievement) or hematological very good partial response (VGPR) (irrespective of organ response achievement) or hematological low-difference in involved and uninvolved free light chain (dFLC) partial response (PR) (irrespective of organ response achievement) or hematological PR with at least one organ response after receiving Dara-CyBorD-based induction.\n\n  * NOTE: Patients with baseline dFLC \\\u003C 5 mg\u002FdL, must have achieved hematological CR, or dFLC \\\u003C 1 mg\u002FdL or achieved organ response prior to randomization\n* Patients in whom bortezomib and\u002For cyclophosphamide were omitted from induction due to toxicity concerns or adverse effects are allowed. Patients must receive at least daratumumab and dexamethasone at induction to qualify for the study\n\n  * NOTE: Dexamethasone use does not need to be carried to end of induction for eligibility consideration\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3\n* Hemoglobin \\>= 8.0 g\u002FdL (obtained =\\\u003C 28 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained =\\\u003C 28 days prior to registration)\n* Platelet count \\>= 50,000\u002Fmm\\^3 (obtained =\\\u003C 28 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only.\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Provide written informed consent\n\n  * NOTE: Informed consent required =\\\u003C 90 days prior registration\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an agent that has possible genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* Received \\>1 cycle of daratumumab maintenance after end of induction therapy and prior to registration\n* Multiple myeloma at time of diagnosis as defined by any of the following:\n\n  * Hypercalcemia: Serum calcium \\> 1 mg\u002FdL higher than upper limit of normal or \\> 11 mg\u002FdL\n  * Renal insufficiency: Creatinine clearance \\\u003C 40 mL per min or serum creatinine \\> 2 mg\u002FdL attributed to high circulating light chains (i.e. cast nephropathy) or hypercalcemia\n  * Anemia: Hemoglobin \\> 2 g\u002FdL below lower limit of normal, or \\\u003C 10 g\u002FdL, attributed to high marrow myeloma infiltration\n  * Bone lesions: \\>= 1 osteolytic lesion on skeletal x-ray, computed tomography (CT), or positron emission tomography (PET)-CT (bone imaging is not mandatory but based on clinical suspicion)\n  * Clonal bone marrow plasma cells \\>= 60%\n  * \\> 1 focal lesion on magnetic resonance imaging (MRI) (MRI is not mandatory but based on clinical suspicion)\n  * If bone imaging (CT, MRI, PET-CT) was not done at time of diagnosis it is not needed to be performed at registration to rule out bone disease\n\n    * \\>= 40% BMPCs irrespective of the above\n  * The study will allow patients with involved: uninvolved serum-free light chain (sFLC) ratio \\>= 100 if this is the only criteria that defines amyloidosis if all the above criteria are not met\n* Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). Note: Subjects with resolved infection (i.e., subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and\u002For antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR\n* Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Unstable angina pectoris\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements",{"count":353,"type":21},96,[66],"This phase II trial compares shorter-duration versus longer-duration maintenance therapy with daratumumab for improving survival in patients who have received initial treatment with daratumumab for light chain (AL) amyloidosis. Maintenance therapy is treatment that is given to help keep cancer from coming back after it has disappeared following initial therapy. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Daratumumab is commonly prescribed as initial treatment for patients with AL amyloidosis. However, it is not known what role daratumumab may play in the maintenance therapy period of patients with AL amyloidosis. This phase II trial compares shorter duration maintenance to longer duration maintenance for improving survival in patients with AL amyloidosis.",[36],"2026-03-26",{"date":359,"type":47},"2026-03-30",{"date":361,"type":47},"2023-07-17",{"date":363,"type":21},"2026-11-30",{"name":365,"class":80},"Mayo Clinic",2,{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":376,"studyType":248,"phases":4,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":54},"100164029","ohio-state-university-multiple-myeloma-and-amyloidosis-data-registry-and-sample-resource-100164029","NCT01408225","Ohio State University Multiple Myeloma and Amyloidosis Data Registry and Sample Resource","Buckeye Surveillance, Contact, and Research for Multiple Myeloma and Amyloidosis","B-SCR-MM","Inclusion:\n\nDiagnosis of a plasma cell dyscrasia\n\nExclusion:\n\nPrisoners are excluded from participation as they have no standard access to the Ohio State myeloma clinic and would impede the research objective of this protocol.",{"count":331,"type":21},"10 Years","The investigators are researching patients with diseases of their plasma cells in order to improve their quality and length of life. The investigators have created a database of patient information, blood samples, and bone marrow tissue in order to achieve the following three goals:\n\n* Surveillance: The investigators want to track what treatments patients get or don't get, how effective they are, how they feel, what complications they suffer, how long they stay in remission, and how long they live.\n* Contact: Because myeloma and amyloidosis are rare, less than 700 patients are diagnosed in the state of Ohio each year, patients often feel they don't have accurate information. The investigators want to provide them access to our clinical team (both phone and email consultations, even office visits for patients that can come to Columbus) as well as information regarding informational events pertaining to your disease and local support groups.\n* Research: Because nearly all myeloma and amyloid patients relapse and treatment is eventually unsuccessful, our focus is to develop more effective treatments that not only prolong life, but cure the disease. Periodically the investigators will inform them about clinical trials studying new drugs or treatment paradigms.",[379,295,36,94],"Plasma Cell Dyscrasias",[153,94,381],"Tissue Bank","2026-03-18",{"date":384,"type":47},"2026-03-23",{"date":386,"type":47},"2011-03-17",{"date":388,"type":21},"2050-03",{"name":390,"class":80},"Ohio State University Comprehensive Cancer Center",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":410,"completionDateStruct":412,"leadSponsor":414,"locationsCount":81},"100530914","optimize-first-line-treatment-for-al-amyloidosis-with-t-11-14-100530914","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.",{"count":399,"type":21},41,[24],"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.",[403,36],"Amyloidosis; Systemic",[405,406,122],"t(11;14)","Rapid Response","2026-03-06",{"date":409,"type":47},"2026-03-09",{"date":411,"type":47},"2024-01-05",{"date":413,"type":21},"2027-03-31",{"name":415,"class":80},"Jin Lu, MD",{"id":417,"slug":418,"hasResults":11,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":423,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":54},"100559823","phase-1-elranatamab-in-patients-with-relapsed-or-refractory-al-amyloidosis-100559823","NCT06569147","Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis","A Phase I\u002FII, Open Label, Study to Evaluate Safety, Tolerability and Efficacy of Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis","Inclusion Criteria:\n\n* Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles).\n* Participants must have progression of light chain disease, defined as dFLC \\>20mg\u002FL.\n* For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light chain (FLC) over 40 mg\u002FL; Abnormal level of FLC with an abnormal κ\u002Fλ ratio (except in participants with CKD stage 3 or higher where a rise of lambda FLC to an abnormal level and of at least 50% over the nadir with a normal κ\u002Fλ ratio is acceptable); A serum M spike measuring ≥ 0.5 g\u002FdL\n* Age ≥ 18 years\n* ECOG performance status ≤2 or Karnofsky ≥60%\n* Participants must meet the following organ and marrow function as defined below: Absolute leukocyte count ≥3,000\u002FmcL , Absolute neutrophil count ≥1,000\u002FmcL, Absolute platelet count ≥75,000\u002FmcL , Direct bilirubin ≤1.5 × institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN, Creatinine: Calculated clearance ≥30 mL\u002Fmin using Cockcault-Groft equation\n* Participants who received belantamab mafodotin are eligible if discontinued due to intolerance or adverse event.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* AL Amyloidosis Cardiac stage I, II or IIIa disease based on the 2013 European Modification of the 2004 Standard Mayo Clinic Staging in participants with advanced cardiac involvement (Dispenzieri et al., 2004; Wechalekar et al., 2013).\n* The effects of elranatamab on the developing human fetus are unknown. Based on the mechanism of action, elranatamab may cause fetal harm when administered to a pregnant woman and therefore should not be used during pregnancy. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and until 90 days since the last dose of elranatamab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of elranatamab administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willingness to undergo study procedures, including bone marrow biopsies as detailed in the schedule of events.\n* Participants should have received prior treatment with Daratumumab + CyBorD.\n\nExclusion Criteria:\n\n* Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.\n* Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* Participants who are receiving any other investigational agents for this condition.\n* Participants with Stage IIIB Amyloidosis as defined by the 2004 Mayo Clinic Criteria (see above).\n* History of allergic reactions to elranatamab.\n* Participants with an active malignancy (including lymphoma) with the following exceptions: adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer; adequately treated stage I cancer from which the patient is currently in remission and has been for over 2 years; low-risk prostate cancer with a Gleason score \\\u003C 7 and prostate specific antigen \\\u003C 10ng\u002FmL; other localized, indolent and\u002For low risk cancer may be permitted\n* Women who are pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or 4 months following discontinuation of elranatamab, whichever is longer. Pregnant women are excluded from this study because elranatamab is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with elranatamab, breastfeeding should be discontinued if the mother is treated with elranatamab.\n* Have any other medical, social or psychological factors that could affect the participant's safety or ability to consent personally or comply with study procedures.\n* Participants meeting criteria for active MM based on presence of CRAB criteria (a ratio of involved versus uninvolved FLC over 100 is allowed in the absence of CRAB criteria).\n* Participants with active clinically significant autoimmune diseases.\n* Participants seropositive for the human immunodeficiency virus (HIV).\n* Severe, uncontrolled orthostatic hypotension resulting in syncopal\u002Fpre-syncopal events despite optimized medical management (e.g., midodrine, pyridostigmine) and in the absence of volume depletion.\n* Plan for autologous stem cell transplant during the first 6 months of protocol therapy.\n* History of acute coronary syndrome or uncontrolled ventricular arrhythmias within 3 months prior to screening.\n* Evidence of LV systolic dysfunction as defined by LVEF is \\\u003C 30% by echocardiogram at Screening per site cardiology interpretation.\n* Presence of severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area \\\u003C 1.0 cm2) or severe congenital heart disease.\n* Have history of sustained ventricular tachycardia or aborted ventricular fibrillation or a history of atrioventricular nodal or sinoatrial nodal dysfunction if a permanent pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) is not placed.\n* QT corrected by Fridericia (QTcF) is \\> 550 msec on Screening ECG unless they have a PPM\u002FICD implanted.\n* Screening EKG showing acute myocardial ischemia or active conduction system abnormalities with the exception of any of the following: First degree atrioventricular block; Second degree atrioventricular block Type 1 (Mobitz Type 1\u002FWenckebach type); Right or left bundle branch block (e.g., Left Bundle Branch Block, Right Bundle Branch Block, Left Anterior Fascicular Block, or Left Posterior Fascicular Block); Atrial fibrillation with a controlled ventricular rate; Bifascicular block assessed as benign by the Investigator\n* Major surgery that required general anesthesia within 4 weeks of randomization or is planning major surgery during the study.\n* NYHA class IV symptoms or participants with acute decompensation of congestive heart failure.\n* Transplant eligible participants who have not undergone transplant are not eligible.",{"count":424,"type":21},49,[65,66],"This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.",[36],"2026-03-05",{"date":407,"type":47},{"date":431,"type":47},"2024-11-01",{"date":433,"type":21},"2029-09-01",{"name":435,"class":80},"Brigham and Women's Hospital",{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":443,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":54},"100627449","investigating-the-pathogenic-role-of-n-glycosylation-in-al-amyloidosis-molecular-bases-diagnosis-and-treatment-100627449","NCT07448779","Investigating the Pathogenic Role of N-glycosylation in AL Amyloidosis: Molecular Bases, Diagnosis, and Treatment","GlycAL","Inclusion Criteria:\n\n* Diagnosis of monoclonal gammopathy (e.g. AL amyloidosis, MGUS, MM, others)\n* Planned peripheral blood sampling +\u002F- bone marrow aspiration\n* Age \\> 18 years\n* Willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes through signing a written informed consent.\n\nExclusion Criteria:\n\n* Lack of monoclonal gammopathy\n* Patients fulfilling the criteria for complete hematologic response after anti-clonal therapy\n* Age \\\u003C18 years\n* Failure to show willingness to allow use of clinical data and diagnostic leftovers of clinical specimens for research purposes.",{"count":247,"type":21},"Immunoglobulin light chain (AL) amyloidosis is caused by a typically small, minimally proliferating bone marrow plasma cell clone secreting a patient-unique, unstable, aggregation-prone, toxic light chain (LC). The amyloidogenicity of LCs is encrypted in their sequence, yet molecular determinants of LC pathogenicity remain obscure. N-glycosylation has been long suspected to be a determinant of LC amyloidogenicity based on anecdotal reports of individual AL patients with a clonal LC displaying this post-translational modification. It is hypothesized that N-glycosylation fundamentally contributes to determining the amyloidogenicity of immunoglobulin LCs in a subset of patients with AL and might influence its clinical phenotype. It is further proposed that the synthesis and secretion of unstable LCs that also have to be N-glycosylated might reverberate on the biology of the plasma cell clone, possibly modulating the sensitivity toward different drugs and might represent itself a therapeutic target.\n\nThe objective of our study is now to elucidate the molecular role of LC N-glycosylation in AL amyloidosis, exploit it for risk assessment, and define its potential impact on the biology of the underlying plasma cell clone and its drug sensitivity.",[36,153,94,446],"Monoclonal Gammopathies","2026-02-25",{"date":449,"type":47},"2026-03-04",{"date":451,"type":47},"2025-11-17",{"date":453,"type":21},"2027-05-30",{"name":259,"class":80},{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":366},"100606183","beamycon-biobank--data-registry-uz-leuven-100606183","NCT07172243","BE.Amycon Biobank & Data Registry UZ Leuven","BE.Amycon Biobank & Data Registry UZ Leuven: Human Body Material (HBM) Collection and Data Collection of Patients With Amyloidosis","Inclusion Criteria:\n\n* Provide consent and sign informed consent form\n* Age 18 years or older\n* Diagnosis of amyloidosis (suspected or confirmed, any subtypes)\n* For the prospective sample collection only: newly diagnosed (any subtype) or at relapse (AL amyloidosis)\n\nExclusion Criteria:\n\n* Not willing to sign informed consent\n* Not able to sign informed consent",{"count":463,"type":21},505,"The goal of this study is to collect and store human body material (HBM) of patients with amyloidosis in a biobank \"BE.Amycon biobank\" for future research and to collect clinical data of patients with amyloidosis in a database \"BE.Amycon data registry\".",[227,36,466],"Amyloidosis Cardiac","2026-02-23",{"date":469,"type":47},"2026-02-27",{"date":471,"type":47},"2025-09-24",{"date":473,"type":21},"2030-01",{"name":475,"class":80},"Universitaire Ziekenhuizen KU Leuven",{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":22,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":54},"100599048","phase-2-teclistamab-in-newly-diagnosed-mayo-stage-iiib-al-amyloidosis-100599048","NCT07079423","Teclistamab in Newly Diagnosed Mayo Stage IIIB AL Amyloidosis","Teclistamab for Newly Diagnosed Mayo Stage IIIB Light-chain Amyloidosis Patients, a Phase II Study","Inclusion Criteria:\n\n* Biopsy confirmed AL amyloidosis\n* Mayo 2004 stage IIIB\n* dFLC ≥ 50mg\u002FL\n\nExclusion Criteria:\n\n* Co-morbidity of uncontrolled infection\n* Co-morbidity of other active malignancy\n* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia\n* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)\n* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia\n* Seropositive for human immunodeficiency virus\n* Hepatitis B virus (HBV)-DNA \\> 1000 copies\u002FmL\n* Seropositive for hepatitis C (except in the setting of a sustained virologic response)\n* Neutrophil \\\u003C1×10E9\u002FL, hemoglobin \\\u003C 8g\u002FdL, or platelet \\\u003C 75×10E9\u002FL.\n* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \\> 5 × upper limit of normal (ULN), total bilirubin \\> 2 × ULN, estimated glomerular filtration rate \\\u003C 20 mL\u002Fmin, or receiving renal replacement therapy",{"count":484,"type":21},35,[66],"This is a phase II study in patients with newly diagnosed Mayo stage IIIB immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab",[36],"2025-07-22",{"date":490,"type":47},"2025-07-23",{"date":492,"type":47},"2025-06-28",{"date":494,"type":21},"2027-12-31",{"name":496,"class":80},"Peking Union Medical College Hospital",{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":504,"targetDuration":4,"studyType":22,"phases":506,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":4},"100597225","phase-2-study-of-eque-cel-car-t-therapy-in-newly-diagnosed-severe-al-amyloidosis-100597225","NCT07055724","Study of Eque-cel CAR-T Therapy in Newly Diagnosed Severe AL Amyloidosis","Exploratory Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T-cell Injection (Equecabtagene Autoleucel, Eque-cel) for the Treatment of Newly Diagnosed Mayo Stage IIIb AL Amyloidosis Patients","Inclusion Criteria:\n\n1. Subjects aged ≥18 years, regardless of gender.\n2. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.\n3. Clinically diagnosed with newly diagnosed AL (light chain) amyloidosis, classified as Mayo Stage IIIb per the revised 2004 Mayo Clinic staging system at screening, with serum N-terminal pro-brain natriuretic peptide (NT-proBNP) \\>8500 ng\u002FL and serum cardiac troponin T (cTnT) \\>0.035 μg\u002FL or cardiac troponin I (cTnI) \\>0.01 g\u002FL.\n4. Presence of measurable hematologic disease at screening, defined as at least one of the following:\n\n   1. Difference in free light chains (dFLC) \\>4 mg\u002FdL, or\n   2. Involved free light chain (iFLC) \\>4 mg\u002FdL with abnormal kappa\u002Flambda (κ\u002Fλ) ratio, or\n   3. Serum protein electrophoresis (SPEP) M protein \\>0.5 g\u002FdL.\n5. Histopathological diagnosis of amyloidosis based on polarized light microscopy of Congo red-stained tissue specimens showing green birefringence, with confirmation of AL-derived amyloid deposits by at least one of the following methods:\n\n   1. Immunohistochemistry\u002Fimmunofluorescence,\n   2. Mass spectrometry,\n   3. Electron microscopy for characteristic appearance\u002Fimmunoelectron microscopy.\n6. Presence of clonal plasma cells in bone marrow, detectable by light microscopy or flow cytometry.\n7. Presence of M protein in blood or urine, with exclusion of multiple myeloma, Waldenström macroglobulinemia, or other lymphoplasmacytic proliferative disorders.\n8. Organ involvement: At least one organ affected (kidney, heart, liver, nervous system, gastrointestinal tract, lung, soft tissue) as per consensus guidelines.\n9. Expected survival time ≥12 weeks.\n10. Subjects must have adequate organ function, meeting all of the following laboratory criteria prior to enrollment:\n\n    1. Complete blood count: Absolute neutrophil count (ANC) ≥1×10⁹\u002FL; absolute lymphocyte count (ALC) ≥0.3×10⁹\u002FL.\n    2. Hemoglobin \\>60 g\u002FL (no red blood cell \\[RBC\\] transfusion within 7 days prior to testing; use of recombinant human erythropoietin allowed).\n    3. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5× upper limit of normal (ULN); total serum bilirubin ≤1.5× ULN.\n    4. Renal function: Creatinine clearance (CrCl) ≥30 mL\u002Fmin as calculated by the Cockcroft-Gault formula.\n    5. Coagulation function: Fibrinogen ≥1.0 g\u002FL; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.\n    6. Blood oxygen saturation \\>91%.\n    7. Echocardiogram showing left ventricular ejection fraction (LVEF) ≥40%.\n    8. Systolic blood pressure (SBP) ≥90 mmHg (oral vasopressor support allowed).\n11. Subjects and their spouses agree to use effective contraceptive methods (tools or medications) from the time of signing the informed consent form until one year after CAR-T cell infusion.\n12. Subjects voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Subjects who have received any of the following treatments prior to enrollment:\n\n   1. Gene therapy before enrollment;\n   2. Live vaccine within 4 weeks before enrollment;\n   3. Other interventional clinical trial drugs within 12 weeks before leukapheresis.\n2. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for cytomegalovirus (CMV) DNA; positive for syphilis testing.\n3. Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \\>20 mg\u002Fday) within 7 days before screening, though physiological replacement, topical, and inhaled steroids are permitted.\n4. Presence of uncontrolled active infection within 7 days before peripheral blood mononuclear cell (PBMC) collection (excluding genitourinary system infections and upper respiratory tract infections \\\u003CCTCAE Grade 2).\n5. Receipt of any systemic therapy for AL amyloidosis within 14 days before PBMC collection.\n6. Undergoing major surgery within 14 days before PBMC collection, or planning surgery within 2 weeks after study treatment (subjects planning local anesthesia surgery are eligible to participate).\n7. Unresolved non-hematologic toxicity from prior therapy to baseline or ≤Grade 1 (per NCI-CTCAE v5.0, excluding alopecia and Grade 2 peripheral neuropathy).\n8. Known life-threatening allergic reaction, hypersensitivity, or intolerance to cellular products or their components.\n9. Subjects with suspected or confirmed symptoms of central nervous system (CNS) involvement by plasma cell tumors.\n10. Bone marrow plasma cells \\>30% with clinical symptoms of multiple myeloma accompanied by osteolytic bone lesions.\n11. Severe active cardiovascular disease with significant clinical symptoms despite treatment, including but not limited to unstable angina, myocardial infarction, and severe arrhythmia (excluding those with implanted implantable cardioverter-defibrillator \\[ICD\\] or pacemaker).\n12. Subjects with bleeding or severe thrombosis symptoms as judged by the investigator, or with genetic\u002Facquired bleeding and severe thrombosis conditions (including hemophilia, coagulopathy, thrombocytopenia, splenomegaly), or currently receiving thrombolytic or anticoagulant therapy.\n13. Subjects with hypertension that cannot be controlled by medication.\n14. Subjects who have received solid organ transplantation.\n15. Subjects with a history of central nervous system disorders (e.g., cerebral aneurysm, epilepsy, stroke, dementia, psychosis) or consciousness impairment.\n16. Subjects with unstable systemic diseases as judged by the investigator, including but not limited to severe liver, kidney, or metabolic diseases requiring medical treatment.\n17. Diagnosis of malignancy other than multiple myeloma within 5 years before screening, excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer post-radical surgery, or ductal carcinoma in situ of the breast post-radical surgery.\n18. Participation in another interventional clinical trial within 1 month before signing the ICF.\n19. Women who are pregnant, breastfeeding, or planning to become pregnant.\n20. Subjects who do not agree to or have not completed the signing of the ICF.\n21. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":505,"type":21},17,[66],"The goal of this clinical trial is to learn if Equecabtagene Autoleucel(Eque-cel), a Chimeric Antigen Receptor T-cell (CAR-T) therapy, works to treat severe Light Chain (AL) Amyloidosis in newly diagnosed adults with Mayo Stage IIIb. It will also learn about the safety and effects of Eque-cel. The main questions it aims to answer are:\n\nDoes Eque-cel lead to hematologic remission (achieving a very good partial response or better) in AL amyloidosis? How safe is Eque-cel for these patients, and what side effects might occur?\n\nParticipants will:\n\nUndergo blood cell collection to create personalized Eque-cel therapy. Receive pre-treatment to prepare their body for the therapy (lymphodepletion). Receive a single infusion of Eque-cel. Be monitored closely for 24 weeks after infusion, followed by long-term checkups for up to 15 years.",[36],[510,126,511],"Eque-cel","Mayo Stage IIIb","2025-07-03",{"date":514,"type":47},"2025-07-09",{"date":516,"type":21},"2025-07",{"date":518,"type":21},"2027-06",{"name":520,"class":521},"Nanjing IASO Biotechnology Co., Ltd.","INDUSTRY",{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":537,"leadSponsor":539,"locationsCount":54},"100587959","phase-2-teclistamab-in-previously-treated-al-amyloidosis-100587959","NCT06935162","Teclistamab in Previously Treated AL Amyloidosis","Teclistamab for Previously Treated Light-chain Amyloidosis Patients, a Phase II Study","Inclusion Criteria:\n\n* Biopsy confirmed AL amyloidosis\n* Patients must have received at least one line of treatment, including daratumumab and bortezomib\n* Relapse from previous treatment, or less than partial response after two cycles of treatment\u002Fless than very good partial response after three cycles of treatment\n* dFLC \\> 50mg\u002FL\n\nExclusion Criteria:\n\n* Previous anti-BCMA targeted therapy\n* Co-morbidity of uncontrolled infection\n* Co-morbidity of other active malignancy\n* Co-diagnosis of multiple myeloma or waldenstrom macroglobulinemia\n* Co-morbidity of grade 2 Mobitz II or grade 3 atrioventricular block (expect for those with implanted pacemaker)\n* Co-morbidity of sustained or recurrent nonsustained ventricular tachycardia\n* Seropositive for human immunodeficiency virus\n* Hepatitis B virus (HBV)-DNA \\> 1000 copies\u002FmL\n* Seropositive for hepatitis C (except in the setting of a sustained virologic response)\n* Neutrophil \\\u003C1×10E9\u002FL, hemoglobin \\\u003C 8g\u002FdL, or platelet \\\u003C 75×10E9\u002FL.\n* Severely compromised hepatic or renal function: alanine transaminase (ALT) or aspertate aminotransferase (AST) \\> 5 × upper limit of normal (ULN), total bilirubin \\> 2 × ULN, eGFR \\\u003C 20 mL\u002Fmin, or receiving renal replacement therapy",{"count":90,"type":21},[66],"This is a phase II study in patients with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the efficacy and safety of teclistamab",[36],"2025-05-21",{"date":535,"type":47},"2025-05-25",{"date":533,"type":47},{"date":538,"type":21},"2028-12-31",{"name":496,"class":80},{"id":541,"slug":542,"hasResults":11,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":22,"phases":549,"briefSummary":550,"conditions":551,"keywords":552,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":366},"100569834","prospective-study-of-teclistamab-in-the-treatment-of-systemic-al-amyloidosis-100569834","NCT06699394","Prospective Study of Teclistamab in the Treatment of Systemic AL Amyloidosis","Teclistamab in Systemic AL Amyloidosis: a Multi-center Prospective Study","Inclusion Criteria:\n\n1. Diagnosis of systemic AL amyloidosis;\n2. Patients must have received standard-of-care daratumumab, bortezomib, they do not have at least one organ response, and have not get complete hematological response;\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.",{"count":548,"type":21},20,[24],"This study aims to evaluate the use of teclistamab in systemic AL amyloidosis and answer whether teclistamab can improve the rate of complete hematological response.\n\nThis is a single-arm, multi-center, prospective study. Participants will receive the single drug teclistamab, which the investigator deems the best choice.",[36],[271,553],"complete hematological response","2025-04-20",{"date":556,"type":47},"2025-04-24",{"date":558,"type":47},"2025-03-29",{"date":560,"type":21},"2026-12-31",{"name":562,"class":80},"Peking University People's Hospital",{"id":564,"slug":565,"hasResults":11,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":569,"eligibilityCriteria":570,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":248,"phases":4,"briefSummary":572,"conditions":573,"keywords":576,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":588,"lastUpdatePostDateStruct":589,"startDateStruct":591,"completionDateStruct":593,"leadSponsor":595,"locationsCount":597},"100581808","the-norwegian-immunotherapy-in-multiple-myeloma-study-100581808","NCT06855121","The Norwegian Immunotherapy in Multiple Myeloma Study","The Norwegian Immunotherapy in Multiple Myeloma Study - A Population-based Longitudinal Observational Multicenter Study on Effectiveness and Complications of Immunotherapy in Multiple Myeloma in the Norwegian Myeloma Cohort","NIMMS","Inclusion criteria\n\n* Participants age ≥ 18 years\n* Prior diagnosis of one of the following\n\n  * Multiple myeloma as defined according to IMWG criteria\n  * Primary plasma cell leukemia as defined according to IMWG consensus definition\n  * AL-amyloidosis as defined according to IMWG criteria\n* Planned treatment with one of the following outside clinical trials (list to be amended based on approvals within the EU):\n\n  * Teclistamab (Tecvayli)\n  * Elranatamab (Elrexfio)\n  * Talquetamab (Talvey)\n  * Idecabtagene vicleucel (ide-cel\u002FAbecma)\n  * Ciltacabtagene autoleucel (cilta-cel\u002FCarvykti)\n\nExclusion Criteria:\n\n* None",{"count":313,"type":21},"The goal of this observational study is to study the effectiveness and complications of novel immunotherapies used in the treatment of multiple myeloma in routine care in Norway. The aim is to close knowledge gaps, generate evidence for future clinical trials and contribute to future consensus on how to monitor for adverse events, and what mitigation strategies should be implemented, so that we can increase patient survival and quality-of-life.",[574,575,36],"Myeloma Multiple","Plasma Cell Leukemia",[577,271,578,579,580,581,582,583,584,585,586,587],"bispesific antibodies","elranatamab","talquetamab","cilta-cel","ide-cel","ciltacabtagene autoleucel","idecabtagene vicleucel","CRS","ICAN","infections","supportive care","2025-02-26",{"date":590,"type":47},"2025-03-03",{"date":592,"type":47},"2025-01-15",{"date":594,"type":21},"2037-12-01",{"name":596,"class":80},"St. Olavs Hospital",23,{"id":599,"slug":600,"hasResults":11,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":606,"targetDuration":608,"studyType":248,"phases":4,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":694,"lastUpdatePostDateStruct":695,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":701,"locationsCount":54},"100521150","national-registry-of-rare-kidney-diseases-100521150","NCT06065852","National Registry of Rare Kidney Diseases","National Registry of Rare Kidney Diseases (RaDaR)","RaDaR","* Kidney Rare Disease\n* Paeds and adults\n* Eligibility differs for each rare disease group\n* See: https:\u002F\u002Fukkidney.org\u002Frare-renal\u002Frecruitment",{"count":607,"type":21},35000,"30 Years","The goal of this National Registry is to is to collect information from patients with rare kidney diseases, so that it that can be used for research.\n\nThe purpose of this research is to:\n\n* Develop Clinical Guidelines for specific rare kidney diseases. These are written recommendations on how to diagnose and treat a medical condition.\n* Audit treatments and outcomes. An audit makes checks to see if what should be done is being done and asks if it could be done better.\n* Further the development of future treatments.\n\nParticipants will be invited to participate on clinical trials and other studies. The registry has the capacity to feedback relevant information to patients and in conjunction with Patient Knows Best (Home - Patients Know Best), allows patients to provide information themselves, including their own reported quality of life and outcome measures.",[611,612,613,36,614,615,616,617,618,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,666,667,668,669,670,671,672,673,674,675,676,677,678,679,680,681,682,683,684,685,686,687,688,689,690,691,692,693],"Adenine Phosphoribosyltransferase Deficiency","AH Amyloidosis","AHL Amyloidosis","Alport Syndrome","Atypical Hemolytic Uremic Syndrome","Autoimmune Distal Renal Tubular Acidosis","Autosomal Recessive Proximal Renal Tubular Acidosis","Autosomal Recessive Distal Renal Tubular Acidosis","Autosomal Dominant Polycystic Kidney Disease","Autosomal Recessive Polycystic Kidney Disease","Bartter Syndrome","BK Nephropathy","C3 Glomerulopathy With Monoclonal Gammopathy","C3 Glomerulopathy","Calciphylaxis","Crystalglobulinaemia","Crystal-storing Histiocytosis","Cystinosis","Cystinuria","Dense Deposit Disease","Dent Disease","Denys-Drash Syndrome","Dominant Hypophosphataemia With Nephrolithiasis and\u002For Osteoporosis","Drug Induced Fanconi Syndrome","Drug-Induced Hypomagnesemia","Drug-Induced Nephrogenic Diabetes Insipidus","Epilepsy, Ataxia, Sensorineural Deafness and Tubulopathy","Fabry Disease","Familial Hypomagnesemia With Hypercalciuria and Nephrocalcinosis","Familial Primary Hypomagnesemia With Hypocalcuria","Familial Primary Hypomagnesaemia With Normocalciuria","Familial Renal Glucosuria","Fanconi Renotubular Syndrome 1","Fanconi Renotubular Syndrome 2","Fanconi Renotubular Syndrome 3","Fibrillary Glomerulonephritis","Fibromuscular Dysplasia","Focal Segmental Glomerulosclerosis","Generalised Pseudohypoaldosteronism Type 1","Gitelman Syndrome","Heavy-Metal-Induced Fanconi Syndrome","Hepatocyte Nuclear Factor 1-Beta-Associated Monogenic Diabetes","Hereditary Renal Hypouricemia","Hereditary Hypophosphatemic Rickets With Hypercalciuria","Hyperuricaemic Nephropathy","IgA Nephropathy","Immunotactoid Glomerulonephritis With Organised Microtubular Mononoclonal Immunoglobulin Deposits","Inherited Renal Cancer Syndromes","Intracapillary Monoclonal IgM Without Cryoglobulin","Intraglomerular\u002FCapillary Lymphoma\u002FLeukaemia","Isolated Autosomal Dominant Hypomagnesaemia Glaudemans Type","Liddle Syndrome","Light Chain Cast Nephropathy","Light Chain Proximal Tubulopathy Without Crystals","Light Chain Proximal Tubulopathy With Crystals","Lowe Syndrome","Membranous Nephropathy","Membranoproliferative Glomerulonephritis","Medullary Cystic Kidney Disease","Minimal Change Nephropathy","Mitochondrial Disease Of The Kidney","Monoclonal Immunoglobulin Deposition Disease","Nail Patella Syndrome","Nephrogenic Diabetes Insipidus","Nephrogenic Syndrome of Inappropriate Antidiuresis","Nephronophthisis","Primary Hypomagnesemia With Secondary Hypocalcemia","Primary Hyperoxaluria","Proliferative Glomerulonephritis With Monoclonal IgG Deposits","Proximal Tubulopathy Without Crystals","Pseudohypoaldosteronism Type 1, 2A-2E","Pure Red Cell Aplasia","Retroperitoneal Fibrosis","Sickle Cell Nephropathy","Shiga Toxin Associated Haemolytic Uraemic Syndrome","Steroid Resistant Nephrotic Syndrome","Steroid-Sensitive Nephrotic Syndrome","Thin Basement Membrane Nephropathy","Thrombotic Microangiopathy With Monoclonal Gammopathy","Type 1 Cryoglobulinaemic Glomerulonephritis","Tuberous Sclerosis","Unclassified Monoclonal Gammopathy Of Renal Significance","Vasculitis","2023-09-26",{"date":696,"type":47},"2023-10-04",{"date":698,"type":47},"2009-11-06",{"date":700,"type":21},"2039-12-31",{"name":702,"class":80},"UK Kidney Association"]