[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641948":3},{"organization":4,"armGroups":7,"interventions":47,"overallOfficials":81,"centralContacts":89,"locations":98,"responsibleParty":150,"collaborators":152,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":163,"sex":169,"minAge":170,"maxAge":94,"enrollmentInfo":171,"targetDuration":94,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":181,"overallStatus":188,"whyStopped":94,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":198},{"fullName":5,"class":6},"University of Leeds","OTHER",[8,16,20,26,31,35,39,43],{"label":9,"type":10,"description":11,"interventionNames":12},"DRd induction","ACTIVE_COMPARATOR","All participants will receive standard of care treatment with daratumumab, lenalidomide, and dexamethasone for an initial 6 cycles.",[13,14,15],"Drug: Daratumumab","Drug: Lenalidomide","Drug: Dexamethasone",{"label":17,"type":10,"description":18,"interventionNames":19},"iFIT1 - DRd to PD","Participants assigned to the iFIT1 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease. Dexamethasone may be stopped due to toxicity.",[13,14,15],{"label":21,"type":22,"description":23,"interventionNames":24},"iFIT1 - Daratumumab plus teclistamab (Dara-Tec)","EXPERIMENTAL","Participants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and teclistamab for a fixed duration and then be actively monitored until progressive disease.",[13,25],"Drug: Teclistamab",{"label":27,"type":22,"description":28,"interventionNames":29},"iFIT1 - Daratumumab plus talquetamab (Dara-Tal)","Participants assigned to the iFIT1 pathway and randomised to this arm will receive treatment with daratumumab and talquetamab for a fixed duration and then be actively monitored until progressive disease.",[13,30],"Drug: Talquetamab",{"label":32,"type":10,"description":33,"interventionNames":34},"iFIT2 - DRd to PD","Participants assigned to the iFIT2 pathway and randomised to this arm will continue standard of care treatment with daratumumab, lenalidomide, and dexamethasone until progressive disease.",[13,14,15],{"label":36,"type":22,"description":37,"interventionNames":38},"iFIT2 - DR to PD","Participants assigned to the iFIT2 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.",[13,14],{"label":40,"type":10,"description":41,"interventionNames":42},"iFIT3 - DR to PD","Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide until progressive disease.",[13,14],{"label":44,"type":22,"description":45,"interventionNames":46},"iFIT3 - DR for 18 cycles","Participants assigned to the iFIT3 pathway and randomised to this arm will continue treatment with daratumumab and lenalidomide for 18 cycles, and then be actively monitored until progressive disease.",[13,14],[48,56,63,69,75],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","Daratumumab","Participants will receive daratumumab by subcutaneous injection. Each cycle is 28 days.",[9,17,27,21,36,32,44,40],[54,55],"D","Dara",{"type":49,"name":57,"description":58,"armGroupLabels":59,"otherNames":60},"Lenalidomide","Taken orally as capsules. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.",[9,17,36,32,44,40],[61,62],"R","Revlimid",{"type":49,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Dexamethasone","Taken as oral tablets, oral solution, or given by IV. Each cycle is 28 days. Dose can be adjusted for frailty and renal function.",[9,17,32],[68],"d",{"type":49,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Teclistamab","Participants will receive teclistamab by subcutaneous injection. Each cycle is 28 days.",[21],[74],"Tec",{"type":49,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Talquetamab","Participants will receive talquetamab by subcutaneous injection. Each cycle is 28 days.",[27],[80],"Tal",[82,86],{"name":83,"affiliation":84,"role":85},"Gordon Cook","Leeds Institute of Clinical Trials Research","STUDY_CHAIR",{"name":87,"affiliation":88,"role":85},"Charlotte Pawlyn","Institute of Cancer Research, United Kingdom",[90,96],{"name":91,"role":92,"phone":93,"phoneExt":94,"email":95},"Emma McNaught","CONTACT","0113 343 1978",null,"ctru-ifit@leeds.ac.uk",{"name":97,"role":92,"phone":94,"phoneExt":94,"email":95},"Catherine Olivier",[99,114,126,138],{"facility":100,"status":94,"city":101,"state":94,"zip":102,"country":103,"countryCode":104,"cosmosGeoPoint":105,"geoPoint":110,"contacts":111},"Bristol Haematology and Oncology Centre","Bristol","BS2 8ED","United Kingdom","UK",{"type":106,"coordinates":107},"Point",[108,109],-2.59665,51.45523,{"lat":109,"lon":108},[112],{"name":113,"role":92,"phone":94,"phoneExt":94,"email":95},"Sally Moore, Dr",{"facility":115,"status":94,"city":116,"state":94,"zip":117,"country":103,"countryCode":104,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Eastbourne District General Hospital","Eastbourne","BN21 2UD",{"type":106,"coordinates":119},[120,121],0.28453,50.76871,{"lat":121,"lon":120},[124],{"name":125,"role":92,"phone":94,"phoneExt":94,"email":95},"John Jones, Dr",{"facility":127,"status":94,"city":128,"state":94,"zip":129,"country":103,"countryCode":104,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"St James University Hospital","Leeds","LS9 7TF",{"type":106,"coordinates":131},[132,133],-1.54785,53.79648,{"lat":133,"lon":132},[136],{"name":137,"role":92,"phone":94,"phoneExt":94,"email":95},"Frances Seymour, Dr",{"facility":139,"status":94,"city":140,"state":94,"zip":141,"country":103,"countryCode":104,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"The Royal Marsden Hospital","London","SM2 5PT",{"type":106,"coordinates":143},[144,145],-0.12574,51.50853,{"lat":145,"lon":144},[148],{"name":149,"role":92,"phone":94,"phoneExt":94,"email":95},"Katy Smith, Dr",{"type":151,"investigatorFullName":94,"investigatorTitle":94,"investigatorAffiliation":94,"oldNameTitle":94,"oldOrganization":94},"SPONSOR",[153,155,158],{"name":154,"class":6},"Cancer Research UK",{"name":156,"class":157},"Blood Cancer UK","UNKNOWN",{"name":159,"class":160},"Johnson & Johnson","INDUSTRY","100641948","phase-3-personalising-treatment-for-myeloma-patients-based-on-initial-response-to-nhs-treatment-and-their-overall-fitness-level-100641948",false,"NCT07649525","Personalising Treatment for Myeloma Patients Based on Initial Response to NHS Treatment and Their Overall Fitness Level","iFIT (UK-MRA Myeloma XVIII): Immunotherapy Approaches Adapted for Fitness in Newly Diagnosed Transplant Ineligible Patients With Myeloma","iFIT","Eligibility criteria for registration:\n\nInclusion criteria for registration:\n\n1. Newly diagnosed as having symptomatic MM, plasma cell leukaemia or non-secretory MM according to IMWG diagnostic criteria 2014.\n2. Considered not suitable to receive autologous stem cell transplant as part of their first line therapy by the treating clinician,\n3. Planned for treatment with Daratumumab, Lenalidomide and dexamethasone (DRd) as first line therapy as standard of care,\n4. Aged 18 years or greater,\n5. Able to provide full informed consent, and\n6. Prepared to comply with pregnancy prevention plan.\n\nExclusion criteria for registration:\n\n1. Smouldering myeloma (SMM), primary amyloidosis, solitary plasmacytoma of bone or extramedullary plasmacytoma (without additional evidence of myeloma),\n2. Pregnant, breastfeeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within 3 months after the last dose,\n3. Previous treatment for myeloma, except as specified in the protocol,\n4. Active systemic viral, fungal or bacterial infection requiring systemic therapy. Criteria for specific chronic infections clarified in the protocol, or\n5. Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring.\n\nAdditional eligibility criteria for randomisation into iFIT1\u002FiFIT2\u002FiFIT3 pathways, as follows:\n\nInclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Completed 6 cycles of DRd induction therapy after registering within the iFIT study,\n* Able to provide full informed consent, and\n* Prepared to comply with pregnancy prevention plan.\n\nInclusion criteria specific to randomisation pathways:\n\n* Dexamethasone may have been stopped due to toxicity and the participant will remain eligible (iFIT1 and iFIT3),\n* Planned to continue on at least daratumumab (monthly) and lenalidomide (at any dose level) (iFIT1 and iFIT3),\n* Planned to continue on all three DRd medications (dose reductions are allowed) (iFIT2),\n* Achieved a partial response (PR) biochemically (irrespective of MRD status) or achieved a ≥VGPR and are MRD positive, as confirmed by HMDS (central laboratory) (iFIT1 and iFIT2),\n* Achieved a ≥VGPR and are MRD negative, as confirmed by HMDS (central laboratory) (iFIT3),\n* Categorised as FIT or UNFIT according to the IMWG frailty index (iFIT1),\n* Categorised as FRAIL according to the IMWG frailty index (iFIT2), and\n* Meet the blood criteria specified in the protocol within 14 days before randomisation (haematological and biochemical) (iFIT1).\n\nExclusion criteria for randomisation into all iFIT1\u002FiFIT2\u002FiFIT3 pathways:\n\n* Received systemic anti-myeloma therapy other than DRd prior to randomisation. Steroids given (by any route) for reasons other than myeloma disease control are allowed,\n* Received a stem cell transplant,\n* Participation in any other interventional study for myeloma that involves an IMP during treatment and active monitoring, and\n* Pregnant, breast feeding, plans to become pregnant, or plans to father a child whilst enrolled in the study or within a specified period after the last dose.\n\nExclusion criteria specific to randomisation pathways:\n\n* Stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT1 and iFIT2),\n* Partial response (PR), stable disease (SD) or progressive disease (PD) as per IMWG response criteria (iFIT3), and\n* Further exclusion criteria related to safety of interventions (iFIT1).\n\nFull inclusion and exclusion criteria are listed in the protocol.","ALL","18 Years",{"count":172,"type":173},1226,"ESTIMATED","INTERVENTIONAL",[176],"PHASE3","iFIT is a trial for newly diagnosed transplant-ineligible patients with the bone marrow cancer myeloma. These patients are generally older and have a lower level of fitness than others. Patients can take part if their doctor would otherwise recommend the standard NHS treatment daratumumab, lenalidomide and dexamethasone (DRd). After six months of DRd, the subsequent treatment a patient receives in iFIT is based on two factors: the patient's fitness level and treatment response. The trial compares different treatment strategies to determine whether outcomes can be improved for specific patient groups.",[179,180],"Multiple Myeloma (MM)","Plasma Cell Leukemia (PCL)",[182,183,184,185,186,187],"Myeloma","Platform adaptive design","Immunotherapy","Frailty","Personalised therapy","Biomarker-driven","NOT_YET_RECRUITING","2026-06-09",{"date":191,"type":192},"2026-06-16","ACTUAL",{"date":194,"type":173},"2026-06",{"date":196,"type":173},"2037-05",{"name":5,"class":6},4]