[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extramedullary-multiple-myeloma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extramedullary-multiple-myeloma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100577067","aponermin-based-bridging-therapy-prior-to-car-t-infusion-in-relapsedrefractory-multiple-myeloma-patients-with-extramedullary-disease-100577067",false,"NCT06793475","Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed\u002FRefractory Multiple Myeloma Patients With Extramedullary Disease","Aponermin-Based Bridging Therapy Prior to CAR-T Infusion in Relapsed\u002FRefractory Multiple Myeloma Patients With Extramedullary Disease: A Prospective, Single-Arm, Multicenter, Open-Label Study","Inclusion Criteria:\n\n1. Be informed and voluntarily sign the Informed Consent Form (ICF).\n2. Age ≥18 years.\n3. Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)\n4. Subjects with diagnosed relapsed or refractory extramedullary multiple myeloma according to IMWG criteria and have had at least 1 prior lines of therapy. Extramedullary disease (EMD) is defined as soft-tissue plasmacytomas NOT arising from skeletal lesions. The maximum diameter of extramedullary lesions should ≥2cm detected by physical exam and confirmed (when required) by Weight Bearing CT\u002FMRI\u002FPET-CT and\u002For biopsy.\n5. ECOG score is ≤ 2\n6. No active infections.\n7. Negative for HBV-DNA, HCV-RNA, and HIV.\n8. Liver function meeting the following criteria: Total bilirubin \\\u003C1.5 × ULN (patients with Gilbert's syndrome must have total bilirubin \\\u003C3 × ULN), ALT and AST \\\u003C3 × ULN.\n9. Renal function meeting the following criteria: Creatinine clearance ≥30mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n10. Blood tests conducted within 7 days before screening must meet the following standards: WBC count ≥1.0×10⁹\u002FL, Hemoglobin ≥70g\u002FL, Platelet count ≥75×10⁹\u002FL or ≥50×10⁹\u002FL (if ≥50% plasma cells are present in bone marrow); Or as determined appropriate by the investigator.\n11. Patients receiving hematopoietic growth factors (e.g., erythropoietin, granulocyte colony-stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\], and platelet-stimulating factors such as thrombopoietin \\[TPO\\] or interleukin-11) must stop such treatments at least 2 weeks prior to screening.\n12. Non-pregnant female patients must confirm pregnancy negativity at screening (via β-hCG serum test or urine pregnancy test).\n13. Male patients, female patients of childbearing potential, and their partners must agree to use effective contraception during the treatment period and for at least 3 months after CAR-T cell infusion.\n14. Male patients must agree not to donate sperm, starting from the initial screening period until 90 days after the last dose.\n15. Patients must agree to comply with study procedures and follow-up visits.\n\nExclusion Criteria:\n\n1. Plasma cell leukemia or solitary plasmacytoma.\n2. Prior exposure to both BCMA- and GPRC5D-targeted therapies (patients who have received only one of these targeted therapies are eligible for enrollment).\n3. Evidence of primary or secondary resistance to elotuzumab, carfilzomib, or thalidomide.\n4. Pregnant or breastfeeding women, or women with pregnancy plans within the next six months.\n5. Infectious diseases (e.g., HIV, active tuberculosis, etc.).\n6. Active hepatitis B or hepatitis C infection.\n7. Abnormal vital signs or inability to cooperate with examinations.\n8. Mental or psychological disorders preventing compliance with treatment or treatment evaluation.\n9. Severe allergic constitution or severe allergic history, particularly to aponermin, carfilzomib, thalidomide, dexamethasone or other effective components or excipients of related drugs.\n10. Significant dysfunction of major organs, such as the heart, lungs, or brain.\n\n9\\) Patients with severe autoimmune diseases. 11) Any other reasons deemed unsuitable for participation in this study as determined by the investigator.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a prospective, single-arm, multicenter, open-label study to evaluate the efficacy and safety of aponermin-based bridging therapy prior to CAR-T infusion in relapsed\u002Frefractory multiple myeloma patients with extramedullary disease.",[26],"Extramedullary Multiple Myeloma","RECRUITING","2025-08-11",{"date":30,"type":31},"2025-08-14","ACTUAL",{"date":33,"type":31},"2025-04-09",{"date":35,"type":20},"2026-12",{"name":37,"class":38},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100526916","phase-2-study-to-evaluate-the-safety-and-efficacy-of-daratumumab-and-carfilzomib-based-inductionconsolidationmaintenance-therapy-in-transplant-eligible-ultra-high-risk-newly-diagnosed-multiple-myeloma-100526916","NCT06140966","Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma","Clinical Study to Evaluate the Safety and Efficacy of Daratumumab and Carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy in Transplant-eligible, Ultra High-risk, Newly Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n1. Patients must have newly diagnosed ultra high-risk disease, as defined by one of the following:1)\"Double hit\"Multiple Myeloma (≥2 adverse markers: t(4;14), t(14;16), t(14;20), 1q21+, del(17p),p53 mutation) ,2)Extramedullary Multiple Myeloma, 3) primary plasma cell leukemia.\n2. Patients must be either untreated or have not received systemic MM therapy. Prior bisphosphonates and localized radiation are allowed.\n3. Aged 18 years to 70 years.\n4. Fit for intensive chemotherapy and autologous stem cell transplant (at clinician's discretion).\n5. Eastern Cooperative Oncology Group (ECOG) score ≤2 before induction chemotherapy.\n\nExclusion Criteria:\n\n1. No evidence of high-risk disease.\n2. Primary diagnosis of Waldenstrom's disease\u002FPOEMS syndrome\u002Flight chain amyloidosis.\n3. Received therapy for multiple myeloma.\n4. Prior or concurrent invasive malignancies.\n5. Eastern Cooperative Oncology Group (ECOG) score \\>2 before induction chemotherapy.\n6. Clinically significant allergies or intolerance to daratumumab,carfilzomib,lenalidomide, dexamethasone, cisPlatin, epirubicin, cyclophosphamide,melphalan, and etoposide.\n7. Participants with contraindication to thromboprophylaxis.\n8. Any uncontrolled or severe cardiovascular or pulmonary disease.\n9. Platelet count \\\u003C 50,000\u002FμL, absolute neutrophil count \\\u003C1000\u002FμL, and haemoglobin \\\u003C60 g\u002FL before induction chemotherapy.\n10. Calculated creatinine clearance \\\u003C30 mL\u002Fmin, alanine transaminase (ALT) or aspertate aminotransferase (AST) \\>3 times upper limit of normal (ULN). Bilirubin \\>2 times ULN, except in participants with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin \\>2.0 times ULN).\n11. Known to be seropositive for history of HIV or known to have active hepatitis B or hepatitis C.\n12. Ejection fraction by echocardiogram (ECHO) ≥ 45%, pulmonary function studies \\\u003C50% of predicted on mechanical aspects (Forced Expiratory Volume 1 (FEV1), Forced Vital Capacity (FVC) and diffusion capacity (DLCO) \\\u003C 50% of predicted.\n13. Uncontrolled or severe cardiovascular or pulmonary disease, clinically significant cardiac disease, uncontrolled diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.\n14. Known\u002Funderlying medical conditions that, in the investigator's opinion, would make the administration of the study drug hazardous.\n15. Participant is a woman who is pregnant, or breast feeding, or planning to become pregnant while enrolled in this trial or within at least 6 months after the last dose of trial treatment. Or, participant is a man who plans to father a child while taking part in this trial or within at least 6 months after the last dose of trial treatment.\n16. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before treatment protocol registration or is currently enrolled in an interventional investigational study.\n17. Major surgery within 2 weeks before treatment protocol registration or has not fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.\n18. Known or suspected of not being able to comply with the study protocol.","70 Years",{"count":48,"type":20},54,[50],"PHASE2","This study will assess whether the combination of daratumumab and carfilzomib-based Induction\u002FConsolidation\u002FMaintenance Therapy with ASCT improves the outcome of patients with ultra high-risk, newly diagnosed multiple myeloma",[53,54,26],"Multiple Myeloma","Primary Plasma Cell Leukemia",[56,57,53,58,54,26,59,60],"Daratumumab","Carfilzomib","Ultra High-risk","Autologous stem cell transplant","Double hit","2025-04-12",{"date":63,"type":31},"2025-04-16",{"date":65,"type":31},"2023-10-20",{"date":67,"type":20},"2027-10-20",{"name":69,"class":38},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",1]