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BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
Sponsor: Anne Louise Tølbøll Sørensen
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.
Official title: A Multicentre, Adaptive, Randomised, Multidomain, Platform Trial for Dose Optimization in the Treatment of Adult Patients With Haematological Diseases (BLOOD-dose): Core Protocol
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2027-03
Completion Date
2036-12
Last Updated
2026-03-16
Healthy Volunteers
No
Interventions
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/refractory multiple myeloma.
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
Locations (5)
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Greater Copenhagen Area, Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Odense University Hospital
Odense, Denmark
Roskilde University Hospital
Roskilde, Denmark