A Phase 4 interventional study of teclistamab OR talquetamab OR elranatamab OR linvoseltamab and BTK inhibitors (ibrutinib and zanubrutinib) in Waldenstrom Macroglobulinaemia and Multiple Myeloma, sponsored by Anne Louise Tølbøll Sørensen. Not yet recruiting at 5 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Anne Louise Tølbøll Sørensen · Phase 4, Interventional, and Treatment
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.
Background:
Approved dosing regimens in haematology are largely derived from clinical trials conducted in relatively homogeneous patient populations, which may not reflect the diversity encountered in routine clinical practice. Many new anticancer and haematological treatments are developed using early phase trial designs that define dose selection primarily based on dose-limiting toxicity, often aiming to establish a maximum tolerated dose. While this approach supports regulatory approval, it may not identify the optimal biological or clinically effective dose for long-term treatment. This uncertainty may contribute to overtreatment, increased toxicity, impaired quality of life, and unnecessary healthcare costs. Furthermore, established long-term or life-long treatment regimens represent important opportunities for dose optimization, especially as therapeutic strategies and patient needs evolve over time.
Platform trials provide an efficient framework to evaluate multiple interventions within a single disease area under a unified master protocol. In domain-based platform trials, interventions are grouped into predefined domains, enabling efficient comparisons, rapid progress, and the addition of new research domains over time.
Objectives:
The BLOOD-dose platform trial aims to determine the optimal treatment intensity for patients with haematological diseases. Due to disease heterogeneity, objectives, endpoints, and estimands will vary across domains.
Outcomes:
Given the heterogeneity of haematological diseases, objectives, endpoints, and estimands will differ across domains. A core outcome set (COS) comprising 6 core outcome measurements has been established through a Delphi consensus process. Each domain is expected to include at least one core outcome measure as its primary endpoint, with all other core outcomes included as secondary endpoints.
Design:
BLOOD-dose is an investigator-initiated, multicentre, adaptive, randomized, multidomain platform trial.
Domains and interventions:
Interventions across different haematological diseases will be defined in domain-specific appendices that will be amended over time.
Eligibility:
In addition to meeting the core protocol eligibility criteria, participants must also meet the domain-specific eligibility criteria for at least one domain.
365 studies on the registry are indexed under Waldenstrom Macroglobulinemia; 62 are open to participants now.
This study's planned enrollment of 400 is above the median of 40 across 316 interventional studies indexed under Waldenstrom Macroglobulinemia.
Browse Waldenstrom Macroglobulinemia studies →This is the only study on the registry with Anne Louise Tølbøll Sørensen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Domain eligibility criteria: each domain has its own specific eligibility criteria detailed in each DSA.
Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma
Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab
Reduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma
Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab
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
Drug: BTK inhibitors (ibrutinib and zanubrutinib)
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
Drug: BTK inhibitors (ibrutinib and zanubrutinib)
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.
Also known as: Tecvayli OR Talvey OR Elrexfio OR Lynozyfic
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
Also known as: Imbruvica OR Brukinsa
Overall survival
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.
Time frame: OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years.
Progression free survival
Clinical progression will be defined in the domain according to the disease being investigated. Clinical progression will be defined in the domain according to the disease being investigated. The end of follow-upperiod will be defined in the DSA.
Time frame: PFS is defined as the time from randomization until clinical progression or death from any cause, assessed up to 5 years.
Patient-reported health-related quality of life
Patient-reported health-related quality of life (HRQOL) will be measured with at least one of the following instruments: Mean change from baseline in the HRQOL score for EORTC QLQ-C30.
Time frame: 1 year
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v6.0
Number of Participants With Treatment Emergent Adverse Events. AEs of interest will be specified in the DSA.
Time frame: Through study completion, an average of 1 year
Hospital Admission
Rate of hospitalisation per 100-participant-patient years. The end of follow-up period will be defined in the DSA.
Time frame: From Time of randomization to end of follow-up, assessed up to 2 years.
Cost of intervention
Exposure to trial medicinal products.
Time frame: From first dose to last recorded date of dosing OR From randomization to last recorded date of dosing or end of study, whichever occurs first, assessed up to 2 years.
Plan to share: Yes — The BLOOD-dose management committee owns the rights to all intellectual property and the combined data collected as part of BLOOD-dose; individual sites retain ownership of data collected at their specific sites. An anonymised version of the final dataset for each domain may be shared with other researchers following a reasonable request (i.e., a research proposal outlining the objectives, methodologies, and plans for data usage) and subsequent approval by the platform and domain management committees. Participants will be informed about the possibility of data sharing during the informed consent process. Analysis code may be shared with other researchers after reasonable request and approval by the platform and domain management committee.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Waldenstrom Macroglobulinemia→