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NOT YET RECRUITING
NCT07474961
PHASE4

BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.

Sponsor: Anne Louise Tølbøll Sørensen

View on ClinicalTrials.gov

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

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/refractory multiple myeloma.

DRUG

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