Health TrialsbyHealthPanel

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

ConditionsWaldenstrom MacroglobulinaemiaMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnne Louise Tølbøll Sørensen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Standard dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamabActive comparator 1 intervention
Group B: Reduced dose of teclistamab OR talquetamab OR elranatamab OR linvoseltamabExperimental treatment 1 intervention
Group C: Standard-dose BTK inhibitors in patients with Waldenström´s macroglobulinemiaActive comparator 1 intervention
Group D: Reduced dose of BTK inhibitors in patients with Waldenström´s macroglobulinemiaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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
3

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
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anne Louise Tølbøll Sørensen

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: