[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carfilzomib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carfilzomib":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100647672","phase-4-a-single-center-prospective-single-arm-clinical-study-exploring-the-treatment-of-newly-diagnosed-multiple-myeloma-patients-with-t1114-suitable-for-transplantation-using-the-sonkrd-regimen-100647672",false,"NCT07709884","A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen","A Single-center, Prospective, Single-arm Clinical Study Exploring the Treatment of Newly Diagnosed Multiple Myeloma Patients With t(11;14) Suitable for Transplantation Using the SonKRd Regimen, Consisting of Sodium Oxychloride, Caffizyme, Lenalidomide and Dexamethasone","Inclusion Criteria:\n\n1. Diagnosed as active multiple myeloma according to the diagnostic criteria outlined in the \"Guidelines for Diagnosis and Treatment of Multiple Myeloma in China (2024 Revision)\";\n2. Aged 18 or above, male or female;\n3. Initial diagnosis of multiple myeloma;\n4. The FISH test confirmed by a third-party laboratory is positive for t(11;14) or the previous FISH test report is positive for t(11;14);\n5. ECOG score of 0-2;\n6. Possessing the following organ function conditions, defined as:\n\n   HGB\\> 80g\u002Fdl Platelets \\> 50×10\\^9\u002FL Neutrophil count \\> 1×10\\^9\u002FL Total bilirubin ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 times ULN; Creatinine clearance rate ≥ 30 mL\u002Fmin Blood oxygen saturation is ≥90%;\n7. Expected survival period is greater than 6 months; The patient understands the purpose and procedures of this trial, voluntarily participates in it, and signs a written informed consent form.\n\nExclusion Criteria:\n\n1. Have received any experimental drug treatment within 2 weeks;\n2. Secondary plasma cell leukemia;\n3. Transmyocardial amyloidosis with heart failure and arrhythmia;\n4. Creatinine clearance rate \\\u003C 30 ml\u002Fmin;\n5. Simultaneous presence of other tumors or a history of tumor, or having undergone anti-tumor treatment (including major surgery) within the last 3 weeks, except for the following tumor diseases or those who have been tumor-free for ≥3 years to date: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM clinical stage T1a or T1b), or previously treated prostate cancer;\n6. Accompanied by mental illnesses requiring inpatient treatment in psychiatric hospitals or controlled institutions, as well as continuous and frequent outpatient treatment, or exhibiting a dependent cognitive state that cannot be controlled by caregivers (confirmed by a specialist physician);\n7. Accompanied by severe pulmonary infection, skin and soft tissue infection, or urinary tract infection;\n8. Patients experiencing unstable angina pectoris or myocardial infarction, heart failure NYHA class III or IV, uncontrolled severe coronary artery disease, uncontrolled severe ventricular arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia or third-degree conduction block within 4 months prior to enrollment, except for those with a cardiac pacemaker;\n9. Poorly controlled hypertension or hyperglycemia within 14 days prior to enrollment;\n10. Severe, uncontrolled medical disorders or active infections that may impair the subject's ability to receive the treatment specified in the protocol, including but not limited to HIV antibody-positive, syphilis antibody-positive, uncontrolled diabetes, and patients undergoing hemodialysis or peritoneal dialysis;\n11. Subjects with uncontrolled active or chronic liver diseases and medical histories (including but not limited to viral hepatitis, cirrhosis, non-alcoholic steatohepatitis) or subjects with significant abnormalities in liver function, or other liver-related diseases that, in the investigator's judgment, may affect drug metabolism or subject safety;\n12. Women who are pregnant or breastfeeding\n13. Situations where researchers determine that the participant is not suitable for enrollment.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this study is to evaluate treatment of newly diagnosed multiple myeloma patients with t(11;14) suitable for transplantation using the SonKRd regimen, consisting of Sodium Thiotepa, Caffizotide, Lenalidomide, and Dexamethasone. Main objectives is to evaluate the MRD negative rate in newly diagnosed multiple myeloma patients with t(11;14) who are eligible for transplantation, treated with the SOTOKLA combined with KRd regimen.\n\nAnd the secondary objective is to evaluate the ORR, CR rate, 1-year sustained MRD negative rate, 2-year PFS rate, and safety of the SOTOLA combined with KRd treatment regimen in newly diagnosed multiple myeloma patients with t(11;14) who are suitable for transplantation.",[26,27,28,29],"Newly Diagnosed Multiple Myeloma","T(11;14)","Sotoclax","Carfilzomib","NOT_YET_RECRUITING","2026-07-16",{"date":33,"type":34},"2026-07-17","ACTUAL",{"date":36,"type":20},"2026-07-01",{"date":38,"type":20},"2028-12-31",{"name":40,"class":41},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100594098","the-efficacy-and-safety-of-the-combination-therapy-of-daratumumab-cabozantinib-pomalidomide-and-dexamethasone-d-kpd-in-the-treatment-of-high-risk-first-time-relapsed-or-primary-refractory-mm-patients-100594098","NCT07015021","The Efficacy and Safety of the Combination Therapy of Daratumumab, Cabozantinib, Pomalidomide, and Dexamethasone (D-KPd) in the Treatment of High-risk First-time Relapsed or Primary Refractory MM Patients","The Efficacy and Safety of the Combination Therapy of Daratumumab, Cabozantinib, Pomalidomide, and Dexamethasone (D-KPd) in the Treatment of High-risk First-time Relapsed or Primary Refractory MM Patients: a Randomized, Open Label, Single Arm, Single Center Clinical Study","DKPD","Inclusion Criteria:\n\n1. Men and women aged ≥ 18 years old;\n2. Functional high-risk patients: Patients who have previously received treatment with VRd or VRd lite regimens for 2-8 courses and achieved therapeutic effects, but have progressed during treatment (primary refractory), experienced clinical recurrence for the first time after treatment, or developed progression or recurrence after the first transplantation (not entered maintenance treatment).\n3. Multiple myeloma patients with measurable M protein must meet at least one of the following three criteria: 1) serum M protein ≥ 10 g\u002FL; 2) Urinary M-protein ≥ 200 mg\u002F24h; 3) In the case of abnormal serum free light chain ratio, the affected free light chain level is ≥ 100 mg\u002FL \\[18\\];\n4. Physical condition (ECOG) score 0-2 points, expected survival period ≥ 3 months;\n5. Hematology meets the following conditions: ANC ≥ 1.0 × 109\u002FL (G-CSF is not allowed to be used within 14 days after screening), patients with ANC\\\u003C1.0 × 109\u002FL can consider screening based on specific circumstances and additional monitoring after discussing with PI and obtaining PI approval; When the number of myeloma cells is less than 50%, PLT ≥ 75 × 109\u002FL, and when the number of myeloma cells is ≥ 50%, PLT ≥ 50 × 109\u002FL (platelet transfusion is not allowed within 7 days after screening); Hemoglobin level ≥ 7.5g\u002FdL.\n6. The creatinine clearance rate measured or calculated by the patient is ≥ 30mL\u002Fmin.\n7. The liver, heart and other major organs meet the requirements of the following laboratory examination indicators (conducted within 7 days before treatment):\n\n1\\) Total bilirubin ≤ 1.5 times the upper limit of normal value (for the same age group); 2) Aspartate transaminase (AST) and alanine aminotransferase (ALT) are ≤ 2.5 times the upper limit of normal values for the same age group; 3) Myocardial enzymes are less than twice the upper limit of normal values for the same age group; 4) The ejection fraction measured by echocardiography (ECHO) is within the normal range.\n\n8\\. Women of childbearing age (FCBP) subjects must have a negative serum pregnancy test 21 days prior to enrollment and agree to use an effective contraceptive method during all study drug periods and within 30 days after the last receipt of the study drug (if pregnancy tests may be conducted more frequently according to local guidelines). This protocol defines FCBP as sexually mature women who have not undergone hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, or have not experienced natural menopause for at least 24 consecutive months (i.e. have had menstruation at any time during the past 24 consecutive months); If there is sexual activity with FCBP, male participants must use an effective barrier contraceptive method during the study period and within 3 months after the last receipt of the study drug. Male participants are not allowed to donate sperm during the treatment period and within 90 days after receiving the study drug for the last time. Male participants whose partners are pregnant must abstain from sexual activity or use condoms during vaginal intercourse; 10. Clearly understand the content of the experiment, voluntarily participate and complete the experiment, and sign the informed consent form. The informed consent form shall be signed by the patient or their immediate family members. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, an informed consent form shall be signed by the legal guardian or the patient's immediate family members; 11. It is necessary to agree to comply with all research requirements, follow-up schedules, outpatient treatment, necessary concomitant medication therapy, and laboratory monitoring.\n\nExclusion Criteria:\n\n1. Non active multiple myeloma, including MGUS and smoking myeloma;\n2. Subjects with POEMS syndrome or known\u002Fsuspected amyloidosis in any organ;\n3. Subjects with plasma cell leukemia: patients with a proportion of peripheral plasma cells ≥ 5% and\u002For an absolute value of peripheral plasma cells ≥ 0.5 × 109\u002FL;\n4. Patients who have been exposed to daratumumab in the past;\n5. Previous malignant tumors that require treatment or have evidence of recurrence within the 5-year period prior to the first study medication \\[excluding basal cell carcinoma of the skin and the following in situ cancers: squamous cell carcinoma, bladder in situ carcinoma, endometrial in situ carcinoma, cervical in situ carcinoma\u002Fatypical hyperplasia, prostate cancer incidentally discovered histologically (TNM staging T1a or T1b), or breast in situ carcinoma\\];\n6. Hepatitis B serum positivity (defined as positive detection of hepatitis B surface antigen \\[HBsAg\\]). The subjects whose infection has subsided (that is, the subjects whose HBsAg is negative but whose hepatitis B B core antigen antibody \\[anti HBc\\] and\u002For hepatitis B B surface antigen antibody \\[anti HBs\\] are positive) must use real-time polymerase chain reaction (PCR) to detect the level of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) for screening. PCR positive individuals will be excluded. Exception: Serological results indicate HBV vaccination (with anti HBs positivity as the sole serological marker) and subjects with a known history of HBV vaccination do not require PCR detection of HBV DNA;\n7. Known to be HIV positive;\n8. Uncontrolled active infections, or acute active infections, require systemic use of antibiotics, antiviral drugs, or antifungal drugs within two weeks prior to the first use of medication;\n9. History of VTE or cerebral infarction before treatment;\n10. The patient has uncontrolled or severe cardiovascular disease, including hypertension that has not been effectively controlled within the past 6 months (hypertension is defined as: non same day 3 measurements of clinic blood pressure without the use of antihypertensive drugs, SBP ≥ 140 mmHg and\u002For DBP ≥ 90 mmHg) Arrhythmia (QT interval prolongation, ventricular tachycardia, ventricular flutter, ventricular fibrillation, frequent ventricular premature beats (24-hour ventricular premature load ≥ 15% of total heart rate), degree atrioventricular block, heart rate\\\u003C30-40 bpm), congestive heart failure, unstable angina or myocardial infarction, New York Heart Association (NYHA) class II, III, IV heart failure, clinically significant pericardial disease;\n11. Participants are known to have chronic obstructive pulmonary disease (COPD) (defined as forced expiratory volume in one second \\[FEV1\\]\\\u003C60% of the predicted normal value), persistent asthma, or a history of asthma within the past 2 years (intermittent asthma or mild persistent asthma allowed to be controlled). Participants with known or suspected COPD must undergo FEV1 testing during the screening period.\n12. Patients who undergo major surgeries within 30 days prior to enrollment that significantly reduce their physical condition and increase the risk of thrombosis, or whose surgical plans are scheduled during the study period. Participants who plan to undergo surgical procedures under local anesthesia that will not significantly affect the patient's physical condition and significantly increase the risk of thrombosis formation are eligible to participate in the study;\n13. Any clinically significant medical disease or condition that the researcher believes may affect compliance with the experimental protocol or the subject's ability to give informed consent;\n14. The subject is a pregnant or lactating female;\n15. Uncontrolled hypertension or uncontrolled diabetes;\n16. Patients who are allergic to the experimental drug;\n17. According to the protocol or the researcher's judgment, patients with serious physical or mental illnesses may interfere with their participation in this clinical study; Drug abuse, medical, psychological, or social conditions that may interfere with subject participation in research or evaluation of research results;\n18. Patients undergoing other experimental drug treatments;\n19. Participants who have participated in other clinical trials within one month;\n20. Any other patients deemed unsuitable for inclusion by researchers.",{"count":52,"type":20},72,[54],"NA","This study is a prospective, single center, single arm phase II clinical trial. The study population consists of patients who have received treatment with VRd or VRd lite regimens for 2-8 courses in the past and have achieved therapeutic effects, but have progressed during treatment (primary refractory), experienced clinical recurrence for the first time after treatment, or progressed or recurred after the first transplant (without entering maintenance therapy). 72 patients are planned to be enrolled and receive 4 courses of induction therapy with D-KPd regimen for the first efficacy evaluation. For patients with ≥ SD, if the patient has ≥ PR and is suitable for ASCT, ASCT treatment will be given. For patients with\\\u003CPR or not suitable for ASCT, 4 courses of consolidation therapy with D-KPd regimen will be continued for the second efficacy evaluation SD patients continue to receive 4 courses of D-KPd regimen consolidation treatment. D-KPd dosing regimen: Daratumumab: 16mg\u002FKg, IV or 1800mg Sc; C1-2 d1,8,15,22; C3-6 d1,15; C7-12 d1。 Cafizomide: 20mg\u002Fm2; C1-8 d1,2,8,9,15,16； C9-12 d1,2,15,16； After tolerance to 20mg\u002Fm2, the dose of C1D1 and C1D2 can be adjusted to 27g\u002Fm2. Pomalidomide: 4mg, PO,d1-21。 Dexamethasone: 20mg, po,d1, 2,8,9,15,16,22,23. If the age is over 75 years old, the Dex dose is halved. The main efficacy endpoint after 12 treatment courses is: ORR； Secondary efficacy endpoint indicators: mPFS, mOS, ≥ VGPR rate, MRD negative rate, safety",[57,29,58,59],"Multiple Myeloma","Daratumumab","Pomalidomide","2025-06-03",{"date":62,"type":34},"2025-06-11",{"date":64,"type":20},"2025-06-01",{"date":66,"type":20},"2026-09-30",{"name":40,"class":41}]