[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fuling Zhou\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100577544","phase-1-a-phase-ibii-clinical-study-on-the-application-of-linperlisib-combined-with-the-vrd-regimen-in-newly-diagnosed-patients-with-multiple-myeloma-100577544",false,"NCT06799676","A Phase Ib\u002FII Clinical Study on the Application of Linperlisib Combined with the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma","A Single-Arm, Multicenter, Open-Label Phase Ib\u002FII Clinical Study on the Application of Linperlisib Plus the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma","Inclusion Criteria:\n\n* 1.Patients must be newly diagnosed with active multiple myeloma. 2. Patients must be between 18 and 65 years old and eligible for autologous hematopoietic stem cell transplantation (ASCT).\n\n  3\\. Patients must have measurable disease, defined as follows:\n* Any quantifiable serum monoclonal protein level (typically but not necessarily ≥0.5 g\u002FdL of M-protein), and\u002For urinary light chain excretion \\>200 mg\u002F24 hours.\n* For oligosecretory or non-secretory multiple myeloma (MM), patients must have measurable plasmacytomas \\>2 cm confirmed by clinical examination or imaging (e.g., MRI, CT scan) or an abnormal free light chain (FLC) ratio (normal value: 0.26-1.65) with an involved FLC level ≥10 mg\u002FdL.\n\n  4\\. Patients must have an expected survival of ≥3 months. 5. Karnofsky Performance Status (KPS) score must be ≥60%. 6. Liver Function:\n* Serum alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) ≤3 times ULN.\n* Direct bilirubin ≤2 mg\u002FdL (34 µmol\u002FL) within 14 days prior to randomization. 7. Neutrophil and Platelet Counts: Absolute neutrophil count (ANC) ≥1.0 × 10⁹\u002FL within 14 days prior to randomization.Platelet count ≥75 × 10⁹\u002FL (or ≥50 × 10⁹\u002FL if \\>50% of bone marrow is involved with myeloma) within 14 days prior to randomization.\n\n  8\\. Creatinine clearance (CrCl) ≥30 mL\u002Fmin, measured or calculated using standard formulas (e.g., Cockcroft-Gault) within 7 days prior to randomization.\n\n  9\\. Corrected serum calcium levels must be ≤14 mg\u002FdL (3.5 mmol\u002FL). 10. Left ventricular ejection fraction (LVEF) must be ≥40%. Two-dimensional transthoracic echocardiography (ECHO) is the preferred method for assessment. If ECHO is unavailable, a multigated acquisition scan (MUGA) is acceptable.\n\n  11\\. Patients must be able to understand and voluntarily sign the informed consent form.\n\n  12\\. Women with childbearing potential must agree to undergo pregnancy testing and use contraception.\n\n  13\\. Male subjects must agree to use contraception.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received anti-myeloma therapy, except for radiotherapy, bisphosphonates, or a single short course of steroids (≤40 mg\u002Fday of dexamethasone equivalent for up to 4 days).\n\n  2\\. Non-secretory MM patients, unless they have abnormal serum free light chains or a measurable plasmacytoma with a minimum maximum diameter \\>2 cm.\n\n  3\\. Patients who do not meet the eligibility criteria for autologous stem cell transplantation.\n\n  4\\. Women who are pregnant or breastfeeding. 5. Acute active infections requiring treatment (ongoing use of systemic antibiotics, antiviral, or antifungal agents) within 14 days prior to randomization.\n\n  6\\. Patients with known human immunodeficiency virus (HIV) infection. 7. Active hepatitis A, B, or C infection. 8. Patients with the following cardiac conditions within 4 months prior to randomization:\n* Unstable angina or myocardial infarction.\n* New York Heart Association (NYHA) Class III or IV heart failure.\n* Uncontrolled angina.\n* Severe coronary artery disease.\n* Severe ventricular arrhythmias.\n* Sick sinus syndrome.\n* Acute ischemia.\n* Electrocardiographic evidence of Grade 3 conduction abnormalities, unless the patient has a pacemaker.\n\n  9\\. Severe neuropathy (Grade 3-4 or Grade 2 with pain) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTC) Version 4.0 within 14 days prior to randomization.\n\n  10\\. Known allergy to any of the investigational drugs. 11. Patients with contraindications to required concomitant medications or supportive therapies, including hypersensitivity to all anticoagulants, antiplatelets, or antiviral agents, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.\n\n  12\\. Any other clinically significant disease or condition that, in the investigator's opinion, could interfere with protocol adherence or the patient's ability to provide informed consent.","ALL","18 Years","65 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study aims to evaluate the safety and efficacy of Linperlisib combined with the VRD regimen in the treatment of newly diagnosed patients with multiple myeloma. The study is divided into a Phase Ib dose exploration phase and a Phase II expansion phase.The Phase Ib dose exploration phase primarily aims to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT). The Phase II expansion phase involves induction therapy using at least four cycles of Linperlisib at RP2D in combination with the VRD regimen. After completing four cycles of induction therapy, patients eligible for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. For patients whose therapeutic evaluation results in PD (progressive disease) or SD (stable disease), alternative treatment regimens will be considered based on their condition. After successful transplantation, 2-4 cycles of the original induction regimen will be used for consolidation therapy.The primary objective is to evaluate the proportion of patients achieving a very good partial response (VGPR) after four cycles of induction therapy with the Linperlisib combined VRD regimen.",[28],"Newly Diagnosed Multiple Myeloma",[30,31,32],"multiple myeloma","PI3Kδ inhibitor","Linperlisib","NOT_YET_RECRUITING","2025-01-27",{"date":36,"type":37},"2025-01-29","ACTUAL",{"date":39,"type":21},"2025-02",{"date":41,"type":21},"2027-10",{"name":43,"class":44},"Fuling Zhou","OTHER",3,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100513801","helical-tomotherapy-in-multiple-myeloma-100513801","NCT05970198","Helical Tomotherapy in Multiple Myeloma","A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma","Inclusion Criteria:\n\n1. Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;\n2. Should agree to comply with all contraceptive requirements; 3, ECOG≤2;\n\n4\\. Total bilirubin, ALT and AST \\\u003C2×UNL (upper limit of normal), BUN \\\u003C 30 mg\u002FdL; 5. At least 2 x 10\\^6 CD34+ cells \u002Fkg were collected; 6.absolute neutrophil count \\>1000\u002FuL and a platelet count of \\>100,000\u002FuL; 7. The expected survival time is more than 3 months; 8. Written informed consent was obtained from the patients or their immediate family members.\n\nExclusion Criteria:\n\nAny of the following was an exclusion criterion:\n\n1. According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;\n2. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);\n3. patients with uncontrolled or severe cardiovascular disease\n4. According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness","75 Years",{"count":55,"type":21},58,[57],"NA","To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.",[60],"Multiple Myeloma","RECRUITING","2023-07-24",{"date":64,"type":37},"2023-08-01",{"date":66,"type":37},"2023-06-14",{"date":68,"type":21},"2027-12-31",{"name":43,"class":44},1,""]