[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"multiple-myeloma-relapsed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:multiple-myeloma-relapsed":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"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":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100596928","quality-of-life-and-treatment-outcomes-in-rrmm-patients-receiving-advanced-vs-conventional-immunotherapies-100596928",false,"NCT07051850","Quality of Life and Treatment Outcomes in RRMM Patients Receiving Advanced vs. Conventional Immunotherapies","Observational Study of Quality of Life, Efficacy, and Safety Following Administration of Advanced Immuno-Oncology Agents Versus Conventional Immunotherapies in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Male or female aged 19 years or older.\n* Diagnosed with multiple myeloma and have been previously treated with at least one proteasome inhibitor, one immunomodulatory drug, and one monoclonal antibody treatment (i.e., exposed to all three classes of immunotherapy agents).\n* Diagnosed with relapsed or refractory multiple myeloma between the IRB approval date and December 2025, and scheduled to start treatment with either advanced immuno-oncology agents or conventional immuno-oncology agents within one month from screening.\n* Provided written informed consent after receiving detailed explanation about the study and voluntarily agreed to participate and comply with study requirements.\n\nExclusion Criteria:\n\n* Those who do not agree to participate in the study.\n* Patients diagnosed with plasma cell disorders other than multiple myeloma (e.g., lymphoma, POEMS syndrome).\n* Individuals unable to read and understand documents written in Korean.","ALL","19 Years",{"count":19,"type":20},174,"ESTIMATED","OBSERVATIONAL","This is a non-interventional observational study aiming to evaluate the quality of life, efficacy, and safety of advanced immuno-oncology agents versus conventional immuno-oncology therapies in patients with relapsed or refractory multiple myeloma. A total of 174 participants are expected to be enrolled in this study.\n\nThe study consists of three parts:\n\nPart 1 is the screening and enrollment phase, during which inclusion and exclusion criteria will be assessed for individuals who have agreed to participate in the study. Eligible participants will be enrolled, and data will be collected on their prioritized treatment value criteria.\n\nPart 2 is the treatment phase, during which participants will receive either conventional immuno-oncology therapy or advanced immuno-oncology agents. Participants will visit the site on Day 1 of each treatment cycle to complete patient-reported outcomes (PROs), and efficacy and safety assessments will be conducted.\n\nPart 3 is the end-of-study visit, during which PROs will again be collected, along with final efficacy and safety assessments.\n\nAdditionally, for exploratory purposes, bone marrow and peripheral blood samples will be collected from participants at Seoul St. Mary's Hospital who have consented to sample collection and provision during the study period.",[24,25],"Multiple Myeloma, Relapsed","Multiple Myeloma (MM)",[27,28,29,30],"Relpased","Refractory","Advanced Immuno-Oncology Agents","Conventional Immunotherapies","RECRUITING","2025-07-10",{"date":34,"type":35},"2025-07-15","ACTUAL",{"date":37,"type":20},"2025-07-14",{"date":39,"type":20},"2025-12-31",{"name":41,"class":42},"Sung-Soo Park","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":43},"100590742","phase-2-study-of-hbi0101-nxc-201-car-t-therapy-in-multiple-myeloma-and-light-chain-amyloidosis-100590742","NCT06971380","Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis","A Phase 2 Trial to Study Efficacy and Safety of HBI0101 (NXC-201) CART in Subjects With Multiple Myeloma and Light-Chain Amyloidosis.","Inclusion Criteria:\n\n1. ≥18 years of age at the time of signing informed consent.\n2. Voluntarily signed informed consent form.\n3. Diagnosis of multiple myeloma and\u002For light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit\n4. Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody, or functionally high-risk patients (i.e. first relapse within 18 months of treatment initiation) may be included.\n\n   Subject with amyloidosis must have been exposed to at least one prior line of therapy which includes proteasome inhibitor or anti-CD38 antibody, or subjects with insufficient response (i.e. not achieving a VGPR or CR after exposure to at least an anti-CD38 antibody and a proteasome inhibitor) may be included.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n6. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n7. Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy.\n8. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n9. Subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation must have no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study.\n\nExclusion Criteria:\n\n1. Contraindication to a study treatment\u002Fprocedure or is anticipated to receive treatment\u002Fprocedure that may preclude performance of study procedures.\n2. Known bulky central nervous system disease.\n3. Inadequate hepatic function defined by aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and direct bilirubin \\> 4x ULN.\n4. Inadequate renal function defined by serum creatinine clearance\u002Festimated clearance of \\\u003C20(ml\u002Fmin).\n5. International ratio (INR) or partial thromboplastin time (PTT) \\> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).\n6. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \\\u003C 1000 cells\u002Fmm\\^3, platelet count \\\u003C 30,000 mm\\^3, or hemoglobin \\\u003C 8 g\u002FdL. Subjects with absolute lymphocyte count \\\u003C 300 cells\u002Fmm\\^3 may be excluded (due to potential challenges with producing CART cells), per investigator judgement.\n7. Echocardiogram with left ventricular ejection fraction \\\u003C 40%.\n8. Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg\u002Fm\\^2\u002Fd hydrocortisone or equivalent)\n9. Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.\n10. Known human immunodeficiency virus (HIV) positive status.\n11. Active Hepatitis B or Hepatitis C active infection.\n12. Active CMV infection.\n13. Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n14. Chronic atrial fibrillation with uncontrolled heart rate.\n15. Second primary malignancies that has required therapy in the last 2 years or is not in complete remission.\n16. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:\n\n    1. Have been on a stable dose of anticoagulation for \\\u003C 1 month (except for acute line insertion induced thrombosis.)\n    2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days\n    3. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n17. Pregnant or lactating women.\n18. Participation in another interventional clinical trial within 30 days prior to screening visit.","18 Years",{"count":53,"type":20},180,"INTERVENTIONAL",[56],"PHASE2","A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.",[59,24,60],"Multiple Myeloma, Refractory to Standard Treatment","Light Chain Amyloidosis",[62,63,64,65],"Relapsed\u002FRefractory Multiple Myeloma","Light-Chain Amyloidosis","B-cell maturation antigen (BCMA)","Autologous CAR-T","2025-05-06",{"date":68,"type":35},"2025-05-14",{"date":70,"type":35},"2025-03-01",{"date":72,"type":20},"2030-05-15",{"name":74,"class":42},"Polina Stepensky"]