[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"FengYan Jin\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":146},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,68,92,121],{"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":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100535512","dara-pd-in-the-treatment-of-patients-with-first-relapse-of-multiple-myeloma-100535512",false,"NCT06252792","Dara-PD in the Treatment of Patients With First Relapse of Multiple Myeloma","Prospective, Multicenter, Open and Non-interference Observational Clinical Study of Daratumumab, Pomalidomide and Dexamethasone (Dara-PD) in the Treatment of Patients With First Relapse of Multiple Myeloma","Inclusion Criteria:\n\nSubjects will be enrolled in this study only if they met all of the following inclusion criteria.\n\n1. Age 18 years or older, regardless of gender.\n2. Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease\n3. First relapse of multiple myeloma;\n4. Receiving first-line anti-multiple myeloma therapy;\n5. The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD);\n6. Subject must have achieved a response (partial response \\[PR\\] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen;\n7. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n8. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.\n\nExclusion Criteria:\n\n1. Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma.\n2. Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course；\n3. Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy；\n4. Subject has received daratumumab or pomalidomide previously；\n5. Subject has a history of malignancy (other than multiple myeloma) within 3 years before the date of randomization (exceptions is malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years).；\n6. Subjects with uncontrollable psychiatric disorders;\n7. Subject is known or suspected of not being able to comply with the study protocol.Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","At present, there is no prospective study on the treatment of first-relapsed multiple myeloma with daratumumab plus pomalidomide and dexamethasone (Dara-Pd). A prospective, multicenter, open, non-interventional, observational clinical study to evaluate the efficacy and safety of Dara-Pd in patients with first relapse multiple myeloma.",[24,25],"Multiple Myeloma","First Relapse",[24,27,28],"First relapse","the second progression free survival time (PFS2)","RECRUITING","2026-03-30",{"date":32,"type":33},"2026-04-03","ACTUAL",{"date":35,"type":33},"2023-06-15",{"date":37,"type":20},"2026-06-15",{"name":39,"class":40},"FengYan Jin","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100523761","individualized-dynamic-frailty-tailored-therapy-dynafit-in-elderly-patients-with-ndmm-100523761","NCT06099912","Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With NDMM","Individualized Dynamic Frailty-tailored Therapy (DynaFiT) in Elderly Patients With Newly Diagnosed Multiple Myeloma: a Prospective and Multi-center Study","DynaFiT","Inclusion Criteria:\n\n* Adult males and females aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant;\n* Subject must have documented multiple myeloma as defined by the criteria below:\n\nMonoclonal plasma cells in the bone marrow 10% or presence of a biopsy-proven plasmacytoma;\n\nMeasurable disease as defined by any of the following:\n\n* Serum monoclonal paraprotein (M-protein) level ≥1.0 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours; or\n* IgA multiple myeloma: serum M-protein level ≥0.5 g\u002FdL or urine M-protein level ≥200 mg\u002F24 hours; or\n* Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg\u002FdL and abnormal serum immunoglobulin kappa lambda free light chain ratio.\n\n  * Has not had prior systemic therapy for multiple myeloma;\n  * The functional reserve of the organs can withstand systemic therapy;\n  * Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.\n\nExclusion Criteria:\n\n* There are active systemic viral, fungal, or bacterial infections that require systemic anti-infective treatment;\n* Severe organ dysfunction (New York Heart Association class III and IV or transaminases ≥5 normal level, except those caused by cardiac and hepatic amyloidosis secondary to MM)\n* Patients with prior history of hematologic or solid tumors treated with radiotherapy or chemotherapy(except ≥5 years);\n* Patients who currently have hematologic tumors or solid tumors that require radiotherapy or chemotherapy;\n* Non-signation of informed consent.","65 Years",{"count":52,"type":20},131,"Frailty is dynamic and confers poor outcomes in elderly patients with newly diagnosed multiple myeloma (NDMM), mainly because of the high prevalence of treatment discontinuation due to intolerability. We designed a multi-center prospective study (DynaFiT) based on our real-life practice to evaluate the feasibility and benefits of a dynamic frailty-tailored therapy in elderly patients with different fitness\u002Ffrailty statuses.\n\nSince Dara-based treatment have recently become the new standard regimens, in this amendment of the study, daratumumab added to VRd is recommended as induction therapy regimen.",[24,55],"Frailty",[57,55,58,59],"Newly diagnosed multiple myeloma","Elderly","Dynamic frailty-tailored therapy","2026-02-11",{"date":62,"type":33},"2026-02-12",{"date":64,"type":33},"2021-09-08",{"date":66,"type":20},"2029-09-08",{"name":39,"class":40},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":41},"100596416","risk-adapted-therapeutic-strategy-in-1q-ndmm-100596416","NCT07045168","Risk-adapted Therapeutic Strategy in +1q NDMM","Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study","Inclusion Criteria:\n\n* Age \\>=18, or \\>=65 and fit according to IMWG-FI.\n* Newly diagnosed NDMM by 2014 IMWG criteria.\n* Adequate organ function for systemic therapy.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Active infections requiring systemic treatment.\n* Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias.\n* History of hematologic or solid tumors treated with chemo\u002Fradiotherapy within 5 years.\n* Current malignancies requiring therapy.\n* Refusal to participate.",{"count":76,"type":20},200,"This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.",[24],[24,80,81,82,83],"Risk-adapted therapeutic strategy","+1q MM","high-risk MM","minimal residual disease","NOT_YET_RECRUITING","2025-09-07",{"date":87,"type":33},"2025-09-15",{"date":87,"type":20},{"date":90,"type":20},"2029-07-04",{"name":39,"class":40},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":41},"100588823","rituximab-methotrexate-and-tepadina-induction-followed-by-etoposide-and-cytarabine-consolidation-in-primary-central-nervous-system-lymphoma-100588823","NCT06946407","Rituximab, Methotrexate, and Tepadina Induction Followed by Etoposide and Cytarabine Consolidation in Primary Central Nervous System Lymphoma","A Prospective, Single-Arm Clinical Study of Rituximab, Methotrexate, and Thiotepa (R-MT) Induction Followed by Etoposide and Cytarabine (EA) Consolidation for Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n* Age ≤ 60 years, male or female\n* Histologically and immunohistochemically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) without prior treatment\n* No evidence of systemic lymphatic or hematopoietic involvement or other systemic disease, based on thorough physical examination and imaging\u002Flaboratory tests\n* Diagnosis meets criteria for Primary Central Nervous System Lymphoma (PCNSL)\n* Written informed consent obtained from the patient or their legal guardian\n* Voluntary agreement to participate in the study\n\nExclusion Criteria:\n\n* Presence of another active malignancy\n* Known history of HIV infection or diagnosis of acquired immunodeficiency syndrome (AIDS)\n* Known allergy to any of the investigational drugs or their excipients\n* Any condition that, in the opinion of the investigator, may lead to early study termination, including but not limited to:\n* Severe comorbidities\n* Significant laboratory abnormalities\n* Serious social or family circumstances affecting safety or compliance","60 Years",{"count":101,"type":20},41,"INTERVENTIONAL",[104],"NA","High-dose methotrexate (HD-MTX) remains the foundation of treatment for primary central nervous system lymphoma (PCNSL), but outcomes are suboptimal. The addition of rituximab has shown mixed results, partly due to limited blood-brain barrier penetration. The MATRix regimen (rituximab, HD-MTX, cytarabine, thiotepa) has improved survival but is associated with significant toxicity.\n\nConsolidation therapy is recommended after induction, but there is no standard approach. Preliminary data suggest that etoposide and cytarabine (EA) consolidation after rituximab-HD-MTX induction may offer improved tolerability, though relapse rates remain high.\n\nThis study evaluates the safety, efficacy, and tolerability of a novel RMT-EA regimen-rituximab, methotrexate, and thiotepa (RMT) induction followed by etoposide and cytarabine (EA) consolidation-in newly diagnosed, untreated PCNSL patients. The aim is to improve remission depth and prolong disease-free survival, especially in younger patients.",[107,108],"Primary Central Nervous System Lymphoma (PCNSL)","CNS Lymphoma Treatment",[110,111,112],"PCNSL","Induction Therapy","Consolidation Therapy","2025-04-23",{"date":115,"type":33},"2025-04-27",{"date":117,"type":33},"2022-12-02",{"date":119,"type":20},"2029-12-01",{"name":39,"class":40},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100524477","a-perspective-study-of-the-mrd-tailored-therapy-in-patients-with-newly-diagnosed-multiple-myeloma-with-persistent-minimal-residual-disease-after-initial-treatment-100524477","NCT06109233","A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment","MRD","Inclusion Criteria:\n\n1. Subject must be at least 18 years of age.\n2. Subject must have documented newly diagnosed symptomatic multiple myeloma as defined by 2014 International Myeloma Working Group criteria.\n3. Subject must have achieved a response (partial response \\[PR\\] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen.\n4. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.\n5. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma. Monoclonal gammopathy of undetermined significance is defined by presence of serum M-protein \\\u003C3 g\u002FdL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less. Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of related organ or tissue impairment or end-organ damage.\n2. Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.\n3. Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy.\n4. Subject is known or suspected of not being able to comply with the study protocol。 Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.",{"count":129,"type":20},80,"The aim of this study was to observe the rate of MRD conversion and the impact on survival in newly diagnosed multiple myeloma (NDMM) patients with persistent MRD positivity after induction and consolidation therapy (autologous hematopoietic stem cell transplantation or consolidation of the original regimen) who were switched to high-intensity therapy, and to compare the rate of persistent MRD-negativity, progression-free survival (PFS), and overall survival (OS) between the two groups in comparison with NDMM patients who achieved MRD-negativity after the same induction and consolidation therapy.",[24,132],"Minimal Residual Disease",[24,134,135,136,137],"MRD-tailored therapy","MRD status","MRD-negative rates","Survival","2024-07-03",{"date":140,"type":33},"2024-07-05",{"date":142,"type":33},"2022-01-10",{"date":144,"type":20},"2026-01-10",{"name":39,"class":40},""]