[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629460":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":42,"centralContacts":46,"locations":56,"responsibleParty":129,"collaborators":50,"id":133,"slug":134,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":135,"sex":141,"minAge":142,"maxAge":50,"enrollmentInfo":143,"targetDuration":50,"studyType":146,"phases":147,"briefSummary":149,"conditions":150,"keywords":153,"overallStatus":156,"whyStopped":50,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab","ACTIVE_COMPARATOR","Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed\u002Frefractory multiple myeloma",[13],"Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab",{"label":15,"type":16,"description":17,"interventionNames":18},"Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab","EXPERIMENTAL","Reduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed\u002Frefractory multiple myeloma",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia","A phase 4, open-label, parallel-group, two-arm domain to assess the effectiveness and safety of reduced-dose BTK inhibitors (ibrutinib and zanubrutinib) compared to standard-dose in male and female patients with Waldenström´s macroglobulinemia",[23],"Drug: BTK inhibitors (ibrutinib and zanubrutinib)",{"label":25,"type":16,"description":26,"interventionNames":27},"Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia","Phase 4, open-label, parallel-group, two-arm domain to assess the effectiveness and safety of reduced-dose BTK inhibitors (ibrutinib and zanubrutinib) compared to standard-dose in male and female patients with Waldenström´s macroglobulinemia",[23],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","teclistamab OR talquetamab OR elranatamab OR linvoseltamab","ElasTEC: A phase 4, open-label, parallel-group, two-arm domain on the BLOOD-dose platform trial to evaluate the non-inferiority, safety, and effectiveness of reduced-frequency bispecific antibody treatments (teclistamab, talquetamab, elranatamab and linvoseltamab) compared with standard-frequency treatment in patients with relapsed\u002Frefractory multiple myeloma.",[15,9],[35],"Tecvayli OR Talvey OR Elrexfio OR Lynozyfic",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"BTK inhibitors (ibrutinib and zanubrutinib)","BELLIS: A phase 4, open-label, parallel-group, two-arm domain to assess the effectiveness and safety of reduced-dose BTK inhibitors (ibrutinib and zanubrutinib) compared to standard-dose in male and female patients with Waldenström´s macroglobulinemia",[25,20],[41],"Imbruvica OR Brukinsa",[43],{"name":44,"affiliation":5,"role":45},"Anne Louise Tølbøll Sørensen, Ass. 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Prof.","+45 46 32 32 00","cbpo@regionsjaelland.dk",{"type":130,"investigatorFullName":131,"investigatorTitle":132,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"SPONSOR_INVESTIGATOR","Anne Louise Tølbøll Sørensen","Clinical Associate Professor","100629460","phase-4-blood-dose-a-platform-trial-evaluating-dose-optimization-in-hematological-diseases-100629460",false,"NCT07474961","BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.","A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol","BLOOD-dose","Inclusion Criteria:\n\n* Participants of any sex who are at least 18 years of age at the time of providing informed consent.\n* Participant diagnosed with a haematological disease, i.e. any disorder that primarily affects the blood, bone marrow, the lymphatic system and\u002For blood-forming organs.\n* Should be eligible for participation in at least one of the currently active domains.\n* Capable of giving signed informed consent for each applicable DSA(s). By consenting to a domain, participants also consent to participation in BLOOD-dose.\n\nExclusion Criteria:\n\n* The participant tient is expected to live less than 3 months, as judged by the investigator.\n* Any condition that, in the opinion of the investigator, impairs the participant's ability to understand trial procedures, provide informed consent and\u002For interfere with participation and\u002For compliance in the trial.\n\nDomain eligibility criteria: each domain has its own specific eligibility criteria detailed in each DSA.","ALL","18 Years",{"count":144,"type":145},400,"ESTIMATED","INTERVENTIONAL",[148],"PHASE4","BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases.\n\nThe BLOOD-dose core protocol outlines the overall clinical trial design that applies to all included interventions, while domain-specific appendices (DSA) detail the unique characteristics of each domain and specify domain-specific interventions.\n\nNew domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.",[151,152],"Waldenstrom Macroglobulinaemia","Multiple Myeloma",[152,154,151,155],"Platform Trial","Dose-optimization","NOT_YET_RECRUITING","2026-03-14",{"date":159,"type":160},"2026-03-16","ACTUAL",{"date":162,"type":145},"2027-03",{"date":164,"type":145},"2036-12",{"name":131,"class":6},5]