Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Waldenstrom Macroglobulinaemia | Waldenstrom Macroglobulinemia | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BTK inhibitors (ibrutinib and zanubrutinib) | Drug | — | UNRESOLVED |
| teclistamab OR talquetamab OR elranatamab OR linvoseltamab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (1)
- BACKGROUNDTannock 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 40049207