BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
BLOOD-dose
A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol
3 other identifiers
interventional
400
1 country
5
Brief Summary
BLOOD-dose is a multicentre, adaptive, randomized, multidomain platform trial designed to optimize treatment dosing strategies in adult patients with haematological diseases. The 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. New domains will be incorporated over time to address distinct dose-optimization research questions across different haematological conditions and interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2027
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 16, 2026
CompletedStudy Start
First participant enrolled
March 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2036
Study Completion
Last participant's last visit for all outcomes
December 1, 2036
March 16, 2026
February 1, 2026
9.8 years
March 4, 2026
March 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
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.
OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years.
Secondary Outcomes (5)
Progression free survival
PFS is defined as the time from randomization until clinical progression or death from any cause, assessed up to 5 years.
Patient-reported health-related quality of life
1 year
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v6.0
Through study completion, an average of 1 year
Hospital Admission
From Time of randomization to end of follow-up, assessed up to 2 years.
Cost of intervention
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.
Study Arms (4)
Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab
ACTIVE COMPARATORStandard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma
Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab
EXPERIMENTALReduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma
Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia
ACTIVE COMPARATORA 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
Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia
EXPERIMENTALPhase 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Participants of any sex who are at least 18 years of age at the time of providing informed consent.
- 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.
- Should be eligible for participation in at least one of the currently active domains.
- Capable of giving signed informed consent for each applicable DSA(s). By consenting to a domain, participants also consent to participation in BLOOD-dose.
You may not qualify if:
- The participant tient is expected to live less than 3 months, as judged by the investigator.
- 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.
- Domain eligibility criteria: each domain has its own specific eligibility criteria detailed in each DSA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Greater Copenhagen Area, 2100, Denmark
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Odense University Hospital
Odense, 5000, Denmark
Roskilde University Hospital
Roskilde, 4000, Denmark
Related Publications (1)
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.
PMID: 40049207BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anne Louise Tølbøll Sørensen, Ass. Prof.
Rigshospitalet, Denmark
Central Study Contacts
Anne Louise Tølbøll Sørensen, Ass. Prof.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
March 4, 2026
First Posted
March 16, 2026
Study Start (Estimated)
March 1, 2027
Primary Completion (Estimated)
December 1, 2036
Study Completion (Estimated)
December 1, 2036
Last Updated
March 16, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 15.01.2030 - 15.01.2055
- Access Criteria
- 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. Data 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. The study protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), and analytical code may be made available upon request. A webaddress for finding more information about the IPD sharing plan is not yet available
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. An 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. Participants will be informed about the possibility of data sharing during the informed consent process. Analysis code may be shared with other researchers after reasonable request and approval by the platform and domain management committee.