[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523761":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":59,"studyPopulation":60,"armGroups":56,"interventions":56,"overallOfficials":56,"centralContacts":56,"locations":61,"responsibleParty":81,"collaborators":85,"id":94,"slug":56,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":56,"enrollmentInfo":103,"targetDuration":56,"studyType":106,"phases":56,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":63,"whyStopped":56,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"The First Hospital of Jilin University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Overall response rate (at least PR) on induction therapy","Overall response rate(ORR) is defined as the percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.","From the date of inclusion to the end of induction therapy, up to 8 months.",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Rate of treatment discontinued(TD)","The effect of intensive or mild treatment based on dynamic frailty status on treatment discontinued(TD) in elderly newly diagnosed multiple myeloma.","The time from the date of inclusion to the date of treatment discontinued from any cause, up to 24 months.",{"measure":19,"description":20,"timeFrame":21},"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.","Baseline, end of every induction cycle and maintenance cycle, until disease progression or treatment discontinued, up to 24 months.",{"measure":23,"description":24,"timeFrame":25},"Early mortality(EM)","Early mortality is defined as death within 3, 6, 12 and 24 months (EM3,EM6,EM12 and EM24).","The time from the date of inclusion to the date of death from any cause, up to 24 months.",{"measure":27,"description":28,"timeFrame":29},"Progression-free survival(PFS)","Progression-free survival(PFS) is defined as the time from inclusion to the time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma.","The time from the date of inclusion to the date of first documented evidence of disease progression or death from any cause, up to 24 months.",{"measure":31,"description":32,"timeFrame":33},"Overall survival (OS)","In each case it is the time from inclusion to the time of death from any cause. Individuals who are lost to follow-up or still alive at the time of analysis will be censored at their last known date to be alive.","The time from the date of inclusion to the date of death from any cause, up to 24 months",[35,39,42,45,48,51],{"measure":36,"description":37,"timeFrame":38},"To establish a new and better comprehensive geriatric assessment system to predict prognosis of elderly NDMM","To establish a new and better comprehensive geriatric frailty assessment system that can predict TD and OS in NDMM patients, combining objective biological markers (biomarkers of sarcopenia, n-terminal pro-brain natriuretic peptide, inflammatory markers such as C-reactive protein, aging biomarkers, and immune markers).","Through study completion, up to 24 months.",{"measure":40,"description":41,"timeFrame":38},"To explore the value of sarcopenia in predicting treatment discontinued(TD) and prognosis of the elderly newly diagnosed multiple myeloma","Number of participants with imaging sarcopenia as assessed by dual-energy X-ray absorptiometry and whole-body low-dose CT;Number of participants with functional sarcopenia as assessed by grip strength and 6-meter walking speed;Number of participants with objective biomarkers in sarcopenia as assessed by peripheral blood test.",{"measure":43,"description":44,"timeFrame":38},"Minimal residual disease (MRD)","By using multiparameter flow cytometry and\u002For next-generation sequencing techniques dynamically monitor MRD status and its effect on OS and PFS",{"measure":46,"description":47,"timeFrame":38},"Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma","Discovery and identification of frailty biomarkers in elderly newly diagnosed multiple myeloma.",{"measure":49,"description":50,"timeFrame":38},"To explore the prognostic significance of blood liquid biopsy based on platelet RNA sequencing for multiple myeloma","Heterogeneity of disease as assessed by platelet RNA sequencing to explore the prognostic significance of blood liquid biopsy based on for multiple myeloma.",{"measure":52,"description":53,"timeFrame":54},"To establish a predictive model for treatment discontinuation in elderly NDMM.","To identify elderly NDMM who are intolerant to standard-dose therapy, a predictive model for treatment discontinuation will be constructed. Proactive management will be implemented for patients at high risk of treatment discontinuation, including appropriate reduction of treatment intensity and active supportive care.","The time from the date of inclusion to the date of treatment discontinued, up to 24 months",{"allocation":56,"interventionModel":56,"interventionModelDescription":56,"primaryPurpose":56,"observationalModel":57,"timePerspective":58,"maskingInfo":56},null,"COHORT","PROSPECTIVE","Older patients with MM represent a heterogeneous population with different fitness\u002Ffrailty statuses. Unlike fit patients who can benefit from intensive therapies due to their endurance, frail patients are often susceptible to treatment-related toxicity, leading to treatment discontinuation and poor outcomes. More importantly, frailty can diminish the prognostic impact of disease-related factors over disease trajectory. Thus, it is of utmost importance to determine the fitness\u002Ffrailty status for treatment decision-making that carefully balances efficacy and safety in this vulnerable population. However, geriatric assessment is often conducted at diagnosis in clinical practice. Although baseline frailty status, as a static risk factor, is significantly associated with OS, its predictive ability decreases over time. Of note, emerging evidence indicates that the fitness\u002Ffrailty status is highly dynamic because of age increase, disease trajectory, and treatment, raising the notion that frailty-tailored therapy should be designed based on the baseline fitness\u002Ffrailty status and also according to its longitudinal changes during the treatment course. Thus, current frailty status better predicts OS.\n\nTo improve outcomes in elderly patients, this study was designed to investigate an entirely novel therapeutic strategy, the dynamic frailty-tailored therapy, in elderly MM patients with different fitness\u002Ffrailty statuses.","Diagnosed with primary multiple myeloma according to the 2014 IMWG multiple myeloma diagnostic criteria,aged ≥65 years who were either transplant-ineligible or had no intent for immediate transplant.",[62],{"facility":5,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Changchun","Jilin","130021","China","CN",{"type":70,"coordinates":71},"Point",[72,73],125.32278,43.88,{"lat":73,"lon":72},[76],{"name":77,"role":78,"phone":79,"phoneExt":56,"email":80},"Fengyan Jin, Professor","CONTACT","+8613844989638","fengyanjin@jlu.edu.cn",{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"SPONSOR_INVESTIGATOR","FengYan Jin","Clinical Professor",[86,88,90,92],{"name":87,"class":6},"Sun Yat-Sen University Cancer Center",{"name":89,"class":6},"Ruijin Hospital",{"name":91,"class":6},"Second Hospital of Shanxi Medical University",{"name":93,"class":6},"The First Affiliated Hospital of Air Force Medicial University","100523761",false,"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.","ALL","65 Years",{"count":104,"type":105},131,"ESTIMATED","OBSERVATIONAL","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.",[109,110],"Multiple Myeloma","Frailty",[112,110,113,114],"Newly diagnosed multiple myeloma","Elderly","Dynamic frailty-tailored therapy","2026-02-11",{"date":117,"type":118},"2026-02-12","ACTUAL",{"date":120,"type":118},"2021-09-08",{"date":122,"type":105},"2029-09-08",{"name":83,"class":6},1]