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

NCT07474961 · tracked via the Priya Life Science Denmark tracker

Sponsor

Anne Louise Tølbøll Sørensen

Phase

Phase 4

Started

2027-03

Last updated

2026-03-16

Condition(s) studied

Waldenstrom MacroglobulinaemiaMultiple Myeloma

Investigational drug(s) / intervention(s)

teclistamab OR talquetamab OR elranatamab OR linvoseltamabAll Teclistamab trials (34) →All Talquetamab trials (20) →All Elranatamab trials (31) →All Linvoseltamab trials (16) →BTK inhibitors (ibrutinib and zanubrutinib)

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

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival — OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years.
To compare survival between the interventions. The interventions will be defined in the DSA. The end of period follow-up will be defined in the DSA.

Trial sites (5)

Facility	City	Region
Copenhagen University Hospital - Rigshospitalet	Copenhagen	Greater Copenhagen Area
Aalborg University Hospital	Aalborg	Denmark
Aarhus University Hospital	Aarhus	Denmark
Odense University Hospital	Odense	Denmark
Roskilde University Hospital	Roskilde	Denmark

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A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma Active, not recruiting

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy Active, not recruiting

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Active, not recruiting

A Study of Combination Therapy With Venetoclax, Daratumumab and Dexamethasone (With and Without Bortezomib) in Participants With Relapsed or Refractory Multiple Myeloma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07474961 on ClinicalTrials.gov ↗ ← All trials in Denmark