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

NCT07474961 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Anne Louise Tølbøll Sørensen

    lead OTHER

Principal Investigators

  • Anne Louise Tølbøll Sørensen, Ass. Prof. · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-31
Primary Completion
2036-12-31
Completion
2036-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474961 on ClinicalTrials.gov