[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596416":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":45,"armGroups":46,"interventions":61,"overallOfficials":41,"centralContacts":41,"locations":68,"responsibleParty":81,"collaborators":41,"id":84,"slug":41,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":41,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":41,"maxAge":41,"enrollmentInfo":91,"targetDuration":41,"studyType":94,"phases":41,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":103,"whyStopped":41,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":41},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"MRD negativity rate","To compare MRD negativity rate between low\u002Fintermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.","through study completion, up to 2 years",{"measure":14,"description":15,"timeFrame":12},"sustained MRD negativity rate","To compare sustained MRD negativity rate between low\u002Fintermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.",{"measure":17,"description":18,"timeFrame":12},"Progression-Free Survival (PFS)","PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death",{"measure":20,"description":21,"timeFrame":12},"Overall Survival (OS)","OS were calculated from the time of enrollment to death or the last follow-up",{"measure":23,"description":24,"timeFrame":12},"objective response rate","To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).",{"measure":26,"description":27,"timeFrame":12},"Treatment related adverse event(TRAE)","Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.",[29,32,35,38],{"measure":30,"description":31,"timeFrame":12},"differences between MRD-negative and MRD-positive patients","Number of participants with distinct immunological (T-cell subsets by flow cytometry), inflammatory (CRP, IL-6 levels), genomic (mutational burden by NGS), and proteomic (LC-MS\u002FMS) signatures in MRD-negative vs. MRD-positive patients.",{"measure":33,"description":34,"timeFrame":12},"elderly +1q NDMM patients","Number of participants achieving MRD negativity (by next-generation sequencing \\[NGS\\] at 10\\^-5 sensitivity) and progression-free survival (PFS) at 24 months in elderly intermediate\u002Fhigh-risk +1q NDMM patients receiving MRD-tailored therapy.",{"measure":36,"description":37,"timeFrame":12},"The efficacy of 1q negativity patients","Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The efficacy of these patients were compared with those of patients stratified by 1q risk through objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR) .",{"measure":39,"description":40,"timeFrame":12},"The survival of 1q negativity patients","Patients with 1q negativity were included as the control group. According to the 2025 IMWG Risk Stratification, patients were divided into the high-risk group and the low-risk group. It is recommended that patients in the high-risk group receive CD38 monoclonal antibody in combination with the KRD regimen, while patients in the low-risk group receive CD38 monoclonal antibody in combination with the VRD regimen. The survival of these patients were compared with those of patients stratified by 1q risk through PFS and OS",null,{"allocation":41,"interventionModel":41,"interventionModelDescription":41,"primaryPurpose":41,"observationalModel":43,"timePerspective":44,"maskingInfo":41},"COHORT","PROSPECTIVE","Newly diagnosed NDMM by 2014 IMWG criteria",[47,52,56,59],{"label":48,"type":41,"description":49,"interventionNames":50},"low-risk +1q NDMM patients","This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting International Staging System (ISS) stage III, hypercalcemia, high lactate dehydrogenase (LDH), and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point) .",[51],"Other: risk-scoring model",{"label":53,"type":41,"description":54,"interventionNames":55},"intermediate\u002Fhigh-risk +1q NDMM patients","This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q was classified into intermediate- (1-3 points) and high-risk (4-7 points) groups.",[51],{"label":57,"type":41,"description":58,"interventionNames":41},"1q negativity low-risk group","Patients with 1q negativity were included as the control group, and patients were stratified into the high-risk group and low-risk group according to the 2025 IMWG Risk Stratification.",{"label":60,"type":41,"description":58,"interventionNames":41},"1q negativity high-risk group",[62],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":66},"risk-scoring model","This system classifies +1q NDMM patients into low, intermediate, and high-risk groups based on coexisting ISS stage III, hypercalcemia, high LDH, and t(14;16).Patients with ISS stage III, elevated LDH, hypercalcemia, and t(14;16) were assigned scores of 1 point, 1 point, 2 points, and 3 points, respectively. According to the tertiles of their scores,the patients with +1q were classified into low- (0 point),intermediate- (1-3 points), and high-risk (4-7 points) groups.",[53,48],[67],"Proposed risk-scoring model for estimating the prognostic impact of 1q gain in patients with newly diagnosed multiple myeloma",[69],{"facility":5,"status":41,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":41},"Changchun","Jilin","130021","China","CN",{"type":76,"coordinates":77},"Point",[78,79],125.32278,43.88,{"lat":79,"lon":78},{"type":82,"investigatorFullName":83,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","FengYan Jin","100596416",false,"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.","ALL",{"count":92,"type":93},200,"ESTIMATED","OBSERVATIONAL","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.",[97],"Multiple Myeloma",[97,99,100,101,102],"Risk-adapted therapeutic strategy","+1q MM","high-risk MM","minimal residual disease","NOT_YET_RECRUITING","2025-09-07",{"date":106,"type":107},"2025-09-15","ACTUAL",{"date":106,"type":93},{"date":110,"type":93},"2029-07-04",{"name":83,"class":6},1]