Waldenstrom MacroglobulinaemiaPhase 4BLOOD-doseNCT07474961
BLOOD-dose: A Platform Trial Evaluating Dose Optimization in Hematological Diseases.
A Phase 4 study testing teclistamab OR talquetamab OR elranatamab OR linvoseltamab and BTK inhibitors (ibrutinib and zanubrutinib) in people with Waldenstrom Macroglobulinaemia and Multiple Myeloma, run by Anne Louise Tølbøll Sørensen at 5 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Waldenstrom Macroglobulinaemia, Multiple Myeloma
- What is being tested?
- teclistamab OR talquetamab OR elranatamab OR linvoseltamab and BTK inhibitors (ibrutinib and zanubrutinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 5 sitesDenmark
- Study dates
- Mar 2027to Dec 2036
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Anne Louise Tølbøll Sørensen, Ass. Prof. contact
5 sites in 1 country
Denmark5 sites
Aalborg University Hospital
Aalborg, 9000
Marianne T Severinsen, Professor, +45 20 84 28 69, m.severinsen@rn.dk
Aarhus University Hospital
Aarhus, 8200
Maja Ø Vase, PhD, +45 21423108, majavase@rm.dk
Copenhagen University Hospital - Rigshospitalet
Copenhagen, Greater Copenhagen Area, 2100
Troels Hammer, Ass. Prof., + 4535455198, troels.hammer@regionh.dk
Odense University Hospital
Odense, 5000
Casper N Strandholdt, MD, +4520541981, casper.norgaard.strandholdt@rsyd.dk
Roskilde University Hospital
Roskilde, 4000
Christian Poulsen, Ass. Prof., +45 46 32 32 00, cbpo@regionsjaelland.dk
About this study
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
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.
Read the detailed description
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.
- Conditions
- Waldenstrom Macroglobulinaemia, Multiple Myeloma
- Being tested
- teclistamab OR talquetamab OR elranatamab OR linvoseltamab, BTK inhibitors (ibrutinib and zanubrutinib)
- Keywords
- Multiple Myeloma, Platform Trial, Waldenstrom Macroglobulinaemia, Dose-optimization
- Medical subject headings
- Waldenstrom Macroglobulinemia, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teclistamab OR talquetamab OR elranatamab OR linvoseltamabDrug
Also called Tecvayli OR Talvey OR Elrexfio OR Lynozyfic
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
Also called Imbruvica OR Brukinsa
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 group | Role | What they receive |
|---|---|---|
| Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab | Active comparator | Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma Receives: Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab |
| Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab | Experimental | Reduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma Receives: Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamab |
| Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia | Active comparator | 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 Receives: Drug: BTK inhibitors (ibrutinib and zanubrutinib) |
| Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia | Experimental | 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 Receives: Drug: BTK inhibitors (ibrutinib and zanubrutinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: OS is defined as the time from randomization until the time of death due to any cause, assessed up to 5 years.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Time of randomization to end of follow-up, assessed up to 2 years.
Cost of intervention
Exposure to trial medicinal products.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Waldenstrom MacroglobulinaemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, adaptive, randomised, multidomain, platform trial
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anne Louise Tølbøll Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anne Louise Tølbøll Sørensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Anne Louise Tølbøll Sørensen, Ass. Prof., Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474961
- Sponsor's protocol ID
- p-2026-20598
- Other IDs
- 2026-525658-13-00, U1111-1334-9059
- Acronym
- BLOOD-dose
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Tannock IF, de Vries EGE, Fojo A, Buyse M, Moja L. Dose optimisation to improve access to effective cancer medicines. Lancet Oncol. 2025 Mar;26(3):e171-e180. doi: 10.1016/S1470-2045(24)00648-X.
PubMed 40049207
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07474961
- Acronym / sponsor ID
- BLOOD-dose / p-2026-20598
- Conditions
- Waldenstrom Macroglobulinaemia, Multiple Myeloma
- Keywords
- Multiple Myeloma, Platform Trial, Waldenstrom Macroglobulinaemia, Dose-optimization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Anne Louise Tølbøll SørensenUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multicentre, adaptive, randomised, multidomain, platform trial
| Arm | Type | Receives |
|---|---|---|
| Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab | Active comparator | Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamabStandard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma |
| Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab | Experimental | Drug: teclistamab OR talquetamab OR elranatamab OR linvoseltamabReduced frequency of teclistamab OR talquetamab OR elranatamab OR linvoseltamab in patients with relapsed/refractory multiple myeloma |
| Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia | Active comparator | Drug: BTK inhibitors (ibrutinib and zanubrutinib)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 |
| Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia | Experimental | 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| teclistamab OR talquetamab OR elranatamab OR linvoseltamabAlso: Tecvayli OR Talvey OR Elrexfio OR LynozyficElasTEC: 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 | Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab, Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamab |
| BTK inhibitors (ibrutinib and zanubrutinib)Also: Imbruvica OR BrukinsaBELLIS: 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 | Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemia, Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemia |
Primary outcome
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.
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.
5 secondary outcomes
Progression free survival
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
Time frame: 1 year
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v6.0
Time frame: Through study completion, an average of 1 year
Hospital Admission
Time frame: From Time of randomization to end of follow-up, assessed up to 2 years.
Cost of intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 40049207Tannock IF, de Vries EGE, Fojo A, Buyse M, Moja L. Dose optimisation to improve access to effective cancer medicines. Lancet Oncol. 2025 Mar;26(3):e171-e180. doi: 10.1016/S1470-2045(24)00648-X.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anne Louise Tølbøll Sørensen, Ass. Prof. contact
Anne Louise Tølbøll Sørensen, Ass. Prof. study chair
Copenhagen University Hospital, Rigshospitalet
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing teclistamab OR talquetamab OR elranatamab OR linvoseltamab and BTK inhibitors (ibrutinib and zanubrutinib) in people with Waldenstrom Macroglobulinaemia and Multiple Myeloma, run by Anne Louise Tølbøll Sørensen at 5 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Louise Tølbøll Sørensen, Ass. Prof. (+45 35451864, anne.louise.toelboell.soerensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.