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

Sponsor
Anne Louise Tølbøll Sørensen
Study ID
NCT07474961
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • teclistamab OR talquetamab OR elranatamab OR linvoseltamab — DRUG
    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) — DRUG
    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

Study Details

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.

Key Dates

Start date
Mar 31, 2027
Status verified
Feb 2026
Primary completion
Dec 31, 2036
Completion
Dec 31, 2036

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab
    Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma
  • Experimental: Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab
    Reduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma
  • Active Comparator: Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia
    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
  • Experimental: Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia
    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

Primary Outcome Measure

Overall survival [ Time Frame: OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years. ]

Central Contacts

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