[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyloid-light-chain-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyloid-light-chain-amyloidosis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100633280","phase-2-dose-schedule-study-of-bcma-bispecific-antibody-elranatamab-for-newly-diagnosed-immunoglobulin-light-chain-al-amyloidosis-100633280",false,"NCT07524634","Dose Schedule Study of BCMA Bispecific Antibody, Elranatamab, for Newly Diagnosed Immunoglobulin Light Chain (AL) Amyloidosis","Dose Schedule Investigation of B-Cell Maturation Antigen (BCMA) Bispecific Antibody, Elranatamab, for Treatment of Newly Diagnosed Light Chain Amyloidosis","Inclusion Criteria:\n\n* Newly diagnosed Immunoglobulin Light Chain (AL) amyloidosis who have not received any prior therapy.\n* Participants must have a tissue biopsy demonstrating Congo red positivity with characteristic birefringence on polarized microscopy and immunohistochemistry or mass spectrometry confirming light chain type.\n* Participants must not have any evidence of myeloma defining events based on the International Myeloma Working Group (IMWG) myeloma diagnostic criteria (SLIM-CRAB). This excludes the light chain ratio criteria of involved versus uninvolved free light chains (FLC) over 100 in the absence of CRAB criteria.\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Participants must meet the following organ and marrow function as defined below: Absolute neutrophil count ≥1,000\u002FmcL, Absolute platelet count ≥50,000\u002FmcL, Direct bilirubin ≤1.5 × institutional upper limit of normal (ULN) AST(SGOT)\u002FALT(SGPT) ≤3 × institutional ULN.\n* Participants must have a clonal plasma cell burden of less than 40%.\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 2015 European Modification of the 2004 Standard Mayo Clinic Staging in participants with advanced cardiac involvement (Dispenzieri et al., 2004; Wechalekar et al., 2013) (NT-proBNP \\\u003C8500 ng\u002FL and troponin criteria per staging system).\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\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents for this condition.\n* Participants with Stage IIIB Amyloidosis as defined by the Europeans Revised 2004 Mayo Clinic Criteria.\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 participant 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 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 or solid organ 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 Left Ventricular (LV) systolic dysfunction as defined by Left Ventricular Ejection Fraction (LVEF) is \\\u003C 30% by echocardiogram at Screening per site cardiology interpretation.\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\n* Participants with a Glomerular Filtration Rate (GFR) \\\u003C20, unless stable on dialysis for at least 3 months","ALL","18 Years",{"count":19,"type":20},64,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This research study is for people who have newly diagnosed with AL (light chain) amyloidosis and have not yet received any treatment for this condition. The purpose of this study is to evaluate whether elranatamab, a type of immunotherapy drug, can produce deep remissions and organ recovery in people with newly diagnosed AL amyloidosis, and to compare two different dosing schedules.\n\nElranatamab (brand name ELREXFIO™) is an investigational (experimental) drug in the setting of AL amyloidosis. It works by connecting immune cells (T-cells) directly to the abnormal plasma cells that are causing amyloidosis, triggering the immune system to destroy those cells. It is not approved by the Food and Drug Administration (FDA) for use in AL amyloidosis.\n\nParticipants in this study will receive elranatamab as a series of injections under the skin (subcutaneously) over 6 treatment cycles (approximately 6 months). Treatment begins with inpatient \"step-up\" doses designed to reduce side effects, followed by two different dosing schedules based on which study arm participants are randomly assigned to. Participants will have regular blood tests, physical exams, bone marrow biopsies, and heart assessments throughout the study, and follow-up visits for up to 2 years after treatment ends.\n\nThis study is randomized, meaning that participants will be assigned by chance (similar to a coin flip) to one of two treatment arms. Participants cannot choose their arm.\n\nParticipation in this research will last approximately 6 months of active treatment, followed by follow-up visits for up to 2 years (with an option to extend to 5 years).",[26],"Amyloid Light-chain Amyloidosis",[28,29,30,31],"B-Cell Maturation Antigen","Elranatamab","Step-up dosing","Bispecific","NOT_YET_RECRUITING","2026-08-03",{"date":35,"type":36},"2026-08-05","ACTUAL",{"date":38,"type":20},"2026-08",{"date":40,"type":20},"2031-06",{"name":42,"class":43},"Case Comprehensive Cancer Center","OTHER",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":5},"100601465","phase-2-teclistamab-daratumumab-in-al-amyloidosis-100601465","NCT07110844","Teclistamab-Daratumumab in AL Amyloidosis","A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis","Inclusion Criteria:\n\n1. Age \\>18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.\n2. Ability to comply with the study protocol, in the investigator's judgment.\n3. Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.\n4. Patient must not have received any prior plasma cell clone-directed therapy.\n5. Measurable hematologic disease, defined as one of the following:\n\n   1. Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg\u002FL and\u002For 5 mg\u002FdL\n   2. Serum M-protein ≥0.5 g\u002FdL on protein electrophoresis\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n7. One or more organs involved by AL amyloidosis as per consensus guidelines\n8. Pre-treatment clinical laboratory values meeting the following criteria during the screening phase:\n\n   1. Absolute neutrophil count ≥0.75 × 10\\^9\u002FL\n   2. Hemoglobin level ≥8.0 g\u002FdL; red blood cell transfusion allowed until 7 days before C1D0.\n   3. Platelet count ≥50 × 10\\^9\u002FL; Platelet transfusions are acceptable without restriction during the Screening period\n   4. Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN)\n   5. Aspartate aminotransferase (AST) ≤2.5 times the ULN\n   6. Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN\n   7. Estimated glomerular filtration rate (eGFR) ≥20 mL\u002Fmin\u002F1.73 m\\^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n9. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs.\n\nFor men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n1. Prior therapy for AL amyloidosis or multiple myeloma with the exception of 160 mg dexamethasone (or equivalent corticosteroid) maximum exposure prior to C1D0.\n2. Patients meeting criteria for symptomatic multiple myeloma by any one of the following: (a) Lytic lesions on imaging (Skeletal survey, whole body CT or MRI, or PET\u002FCT) (b) Plasmacytoma, (c) Hypercalcemia without any alternate etiology, (d) Bone marrow plasma cell infiltrate of greater than 60%.\n\n   Patients with involved\u002Funinvolved serum FLC ratio\\>100 as the sole myeloma-defining event will be allowed.\n3. Evidence of significant cardiovascular conditions as specified below:\n\n   1. NT-Pro BNP \\> 8500 pg\u002FmL, and\u002For\n   2. NYHA Class IIIb or IV functional class\n4. History of other malignancy that could affect compliance with the protocol or interpretation of results.\n\n   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.\n5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to, uncontrolled systemic infection (viral, bacterial, or fungal).\n6. Patients on renal replacement therapy\n7. Patients with HIV who are not on HAART or those with active hepatitis A, B, or C infection.\n8. Planned stem cell transplant during the first 6 cycles of protocol therapy are excluded. Stem cell collection during the first 6 cycles of protocol therapy is permitted, as per investigators' discretion.\n9. Known hypersensitivity to any of the agents\n10. Patients who are receiving any other investigational agent concurrently.","100 Years",{"count":54,"type":20},25,[23],"The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis.\n\nThe study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.",[26],[59,60,61,62],"Untreated AL Amyloidosis","untreated light chain amyloidosis","light chain amyloidosis","AL Amyloidosis","RECRUITING","2026-07-09",{"date":66,"type":36},"2026-07-13",{"date":68,"type":36},"2025-11-07",{"date":70,"type":20},"2033-10",{"name":72,"class":43},"Rajshekhar Chakraborty, MD",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100551104","daratumumabdaratumumab-and-hyaluronidase-fihj-in-combination-with-pomalidomide-and-dexamethasone-for-the-treatment-of-patients-with-newly-diagnosed-al-amyloidosis-a-prospective-multicenter-single-arm-study-100551104","NCT06455748","Daratumumab\u002FDaratumumab and Hyaluronidase-fihj in Combination With Pomalidomide and Dexamethasone for the Treatment of Patients With Newly Diagnosed AL Amyloidosis: a Prospective, Multicenter, Single-arm Study","Inclusion Criteria:\n\n1. Age: 18-80 years old, diagnosed with primary amyloidosis of AL tissue;\n2. ECOG PS score 0-2 points;\n3. Measurable disease: The difference between affected and unaffected FLC is\\>20 mg\u002FL, and the serum immunoglobulin kappa λ FLC ratio is abnormal;\n4. Having sufficient organ and bone marrow function, defined as follows:\n\n   1. Blood routine: Absolute neutrophil count ≥ 1.0 x 10 \\^ 9\u002FL, platelet count ≥ 50 x 10 \\^ 9\u002FL;\n   2. Blood biochemistry and electrolytes: ALT and AST both ≤ 3 times the upper limit of normal, total bilirubin ≤ 1.5 times the upper limit of normal, creatinine clearance rate ≥ 30 mL\u002Fmin, serum corrected calcium ≤ 14.0 mg\u002FdL (≤ 3.5 mmol\u002FL) or free ion calcium ≤ 6.5 mg\u002FdL (≤ 1.6 mmol\u002FL);\n5. Women of childbearing age must agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 3 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test was negative and must be a non lactating patient; In addition, if the subject misses their menstrual period or experiences abnormal menstrual bleeding, the researcher can conduct a pregnancy trial at any time during the study period;\n6. Men must agree to use contraceptive measures during the study period and within 3 months after the end of the study period;\n7. The patient agrees to participate in the clinical trial and signs an informed consent form.\n\nExclusion Criteria:\n\n1. Non AL amyloidosis;\n2. Known to be allergic, hypersensitive or intolerant to monoclonal antibodies or human derived proteins, daretozumab or its excipients, or known to be allergic to mammalian derivatives;\n3. Female patients who have tested positive for lactation or serum pregnancy test during the screening period;\n4. Received ASCT or had graft-versus-host disease in the past 12 months;\n5. Suffering from moderate or severe persistent asthma within 2 years prior to enrollment, or having uncontrolled asthma at the time of enrollment;\n6. Evidence of having other malignant tumors within the 3 years prior to enrollment or having been previously diagnosed with another malignant tumor with any residual lesions;\n7. Suffering from chronic obstructive pulmonary disease (COPD), the forced expiratory volume (FEV1) in one second is less than 50% of the normal expected value;\n8. Clinically significant heart disease, including:\n\n   1. Start studying myocardial infarction or unstable or uncontrollable conditions within 6 months prior to treatment (such as unstable angina, congestive heart failure, New York Heart Association (NYHA) III-IV);\n   2. Arrhythmias (NCI CTCAE V5.0 standard ≥ grade 3) or clinically significant electrocardiogram (ECG) abnormalities;\n   3. The electrocardiogram shows a baseline corrected QT (QTc) interval\\>470 ms;\n9. Active infections, including but not limited to HAV, HBV, HCV, HIV;\n10. Plasma cell leukemia (circulating plasma cells\\>2.0 × 10 \\^ 9\u002FL) or Waldenstrom macroglobulinemia (WM) or POEMS syndrome (multiple neuropathies, organ enlargement, endocrine disorders, monoclonal plasma cell disease, and skin changes);\n11. Peripheral neuropathy or neuralgia of grade 2 or above (CTCAE 5.0 standard);\n12. Underwent major surgery within 14 days prior to enrollment, or did not fully recover from early surgery, or planned surgery during the study period or within 14 days after the last study drug treatment (note: does not include surgery under local anesthesia or kyphoplasty or vertebroplasty);\n13. According to the judgment of the investigator, there are concomitant diseases (such as active systemic infection, uncontrolled diabetes, acute diffuse invasive pulmonary disease, neurological or mental disease, etc.) or any other conditions that may confuse the research results or affect the completion of the study;\n14. Individuals who are receiving any other experimental drugs or experimental medical devices;\n15. The researchers believe that the patient has other circumstances that are not suitable for participation in this study.","80 Years",{"count":81,"type":20},20,[83],"NA","This is a prospective and single arm clinical study. The goal of this clinical trial is to observe and evaluate the efficacy and safety of Daratumumab\u002Fdaratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone in the treatment of patients with newly diagnosed AL amyloidosis.",[26],"2024-06-06",{"date":88,"type":36},"2024-06-12",{"date":90,"type":36},"2024-03-01",{"date":92,"type":20},"2025-03-01",{"name":94,"class":43},"Yongyong MA",1]