Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:22 AM
Study NCT ID:
NCT07474961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008258', 'term': 'Waldenstrom Macroglobulinemia'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730985', 'term': 'talquetamab'}, {'id': 'C551803', 'term': 'ibrutinib'}, {'id': 'C000629551', 'term': 'zanubrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicentre, adaptive, randomised, multidomain, platform trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2036-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2036-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years.', 'description': 'To compare survival between the interventions. The interventions will be defined in the DSA. The end of period follow-up will be defined in the DSA.'}], 'secondaryOutcomes': [{'measure': 'Progression free survival', 'timeFrame': 'PFS is defined as the time from randomization until clinical progression or death from any cause, assessed up to 5 years.', 'description': 'Clinical progression will be defined in the domain according to the disease being investigated. Clinical progression will be defined in the domain according to the disease being investigated. The end of follow-upperiod will be defined in the DSA.'}, {'measure': 'Patient-reported health-related quality of life', 'timeFrame': '1 year', 'description': 'Patient-reported health-related quality of life (HRQOL) will be measured with at least one of the following instruments: Mean change from baseline in the HRQOL score for EORTC QLQ-C30.'}, {'measure': 'Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v6.0', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Number of Participants With Treatment Emergent Adverse Events. AEs of interest will be specified in the DSA.'}, {'measure': 'Hospital Admission', 'timeFrame': 'From Time of randomization to end of follow-up, assessed up to 2 years.', 'description': 'Rate of hospitalisation per 100-participant-patient years. The end of follow-up period will be defined in the DSA.'}, {'measure': 'Cost of intervention', 'timeFrame': 'From first dose to last recorded date of dosing OR From randomization to last recorded date of dosing or end of study, whichever occurs first, assessed up to 2 years.', 'description': 'Exposure to trial medicinal products.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Platform Trial', 'Waldenstrom Macroglobulinaemia', 'Dose-optimization'], 'conditions': ['Waldenstrom Macroglobulinaemia', 'Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '40049207', 'type': 'BACKGROUND', 'citation': 'Tannock IF, de Vries EGE, Fojo A, Buyse M, Moja L. Dose optimisation to improve access to effective cancer medicines. Lancet Oncol. 2025 Mar;26(3):e171-e180. doi: 10.1016/S1470-2045(24)00648-X.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Background:\n\nApproved dosing regimens in haematology are largely derived from clinical trials conducted in relatively homogeneous patient populations, which may not reflect the diversity encountered in routine clinical practice. Many new anticancer and haematological treatments are developed using early phase trial designs that define dose selection primarily based on dose-limiting toxicity, often aiming to establish a maximum tolerated dose. While this approach supports regulatory approval, it may not identify the optimal biological or clinically effective dose for long-term treatment. This uncertainty may contribute to overtreatment, increased toxicity, impaired quality of life, and unnecessary healthcare costs. Furthermore, established long-term or life-long treatment regimens represent important opportunities for dose optimization, especially as therapeutic strategies and patient needs evolve over time.\n\nPlatform trials provide an efficient framework to evaluate multiple interventions within a single disease area under a unified master protocol. In domain-based platform trials, interventions are grouped into predefined domains, enabling efficient comparisons, rapid progress, and the addition of new research domains over time.\n\nObjectives:\n\nThe BLOOD-dose platform trial aims to determine the optimal treatment intensity for patients with haematological diseases. Due to disease heterogeneity, objectives, endpoints, and estimands will vary across domains.\n\nOutcomes:\n\nGiven the heterogeneity of haematological diseases, objectives, endpoints, and estimands will differ across domains. A core outcome set (COS) comprising 6 core outcome measurements has been established through a Delphi consensus process. Each domain is expected to include at least one core outcome measure as its primary endpoint, with all other core outcomes included as secondary endpoints.\n\nDesign:\n\nBLOOD-dose is an investigator-initiated, multicentre, adaptive, randomized, multidomain platform trial.\n\nDomains and interventions:\n\nInterventions across different haematological diseases will be defined in domain-specific appendices that will be amended over time.\n\nEligibility:\n\nIn addition to meeting the core protocol eligibility criteria, participants must also meet the domain-specific eligibility criteria for at least one domain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/or 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/or interfere with participation and/or compliance in the trial.\n\nDomain eligibility criteria: each domain has its own specific eligibility criteria detailed in each DSA."}, 'identificationModule': {'nctId': 'NCT07474961', 'acronym': 'BLOOD-dose', 'briefTitle': 'BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol', 'orgStudyIdInfo': {'id': 'p-2026-20598'}, 'secondaryIdInfos': [{'id': '2026-525658-13-00', 'type': 'CTIS'}, {'id': 'U1111-1334-9059', 'type': 'OTHER', 'domain': 'WHO UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab', 'description': 'Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma', 'interventionNames': ['Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab']}, {'type': 'EXPERIMENTAL', 'label': 'Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab', 'description': 'Reduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma', 'interventionNames': ['Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia', 'description': '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', 'interventionNames': ['Drug: BTK inhibitors (ibrutinib and zanubrutinib)']}, {'type': 'EXPERIMENTAL', 'label': 'Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia', 'description': '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', 'interventionNames': ['Drug: BTK inhibitors (ibrutinib and zanubrutinib)']}], 'interventions': [{'name': 'teclistamab OR talquetamab OR elranatamab OR linvoseltamab', 'type': 'DRUG', 'otherNames': ['Tecvayli OR Talvey OR Elrexfio OR Lynozyfic'], 'description': '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/refractory multiple myeloma.', 'armGroupLabels': ['Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab', 'Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab']}, {'name': 'BTK inhibitors (ibrutinib and zanubrutinib)', 'type': 'DRUG', 'otherNames': ['Imbruvica OR Brukinsa'], 'description': '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', 'armGroupLabels': ['Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia', 'Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Greater Copenhagen Area', 'country': 'Denmark', 'contacts': [{'name': 'Troels Hammer, Ass. Prof.', 'role': 'CONTACT', 'email': 'troels.hammer@regionh.dk', 'phone': '+ 4535455198'}], 'facility': 'Copenhagen University Hospital - Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'contacts': [{'name': 'Marianne T Severinsen, Professor', 'role': 'CONTACT', 'email': 'm.severinsen@rn.dk', 'phone': '+45 20 84 28 69'}], 'facility': 'Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'contacts': [{'name': 'Maja Ø Vase, PhD', 'role': 'CONTACT', 'email': 'majavase@rm.dk', 'phone': '+45 21423108'}], 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'contacts': [{'name': 'Casper N Strandholdt, MD', 'role': 'CONTACT', 'email': 'casper.norgaard.strandholdt@rsyd.dk', 'phone': '+4520541981'}], 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'contacts': [{'name': 'Christian Poulsen, Ass. Prof.', 'role': 'CONTACT', 'email': 'cbpo@regionsjaelland.dk', 'phone': '+45 46 32 32 00'}], 'facility': 'Roskilde University Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Anne Louise Tølbøll Sørensen, Ass. Prof.', 'role': 'CONTACT', 'email': 'anne.louise.toelboell.soerensen@regionh.dk', 'phone': '+45 35451864'}, {'name': 'Troels Hammer, Ass. Prof.', 'role': 'CONTACT', 'email': 'troels.hammer@regionh.dk', 'phone': '+45 35455198'}], 'overallOfficials': [{'name': 'Anne Louise Tølbøll Sørensen, Ass. Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '15.01.2030 - 15.01.2055', 'ipdSharing': 'YES', 'description': 'The BLOOD-dose management committee owns the rights to all intellectual property and the combined data collected as part of BLOOD-dose; individual sites retain ownership of data collected at their specific sites.\n\nAn anonymised version of the final dataset for each domain may be shared with other researchers following a reasonable request (i.e., a research proposal outlining the objectives, methodologies, and plans for data usage) and subsequent approval by the platform and domain management committees.\n\nParticipants will be informed about the possibility of data sharing during the informed consent process.\n\nAnalysis code may be shared with other researchers after reasonable request and approval by the platform and domain management committee.', 'accessCriteria': 'An anonymised version of the final dataset for each domain may be shared with other researchers upon reasonable request. Requests should include a research proposal outlining the objectives, methodologies, and intended use of the data, and will be subject to review and approval by the platform and relevant domain management committees.\n\nData sharing will be conducted in accordance with the General Data Protection Regulation (GDPR) and all applicable national and international legislative and regulatory requirements governing the protection of personal data. Only fully anonymised data will be shared, and appropriate safeguards and data governance procedures will be applied to ensure compliance with data protection obligations.\n\nThe study protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), and analytical code may be made available upon request.\n\nA webaddress for finding more information about the IPD sharing plan is not yet available'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anne Louise Tølbøll Sørensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Anne Louise Tølbøll Sørensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}