A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

  • STATUS
    Recruiting
  • End date
    Jun 18, 2024
  • participants needed
    150
  • sponsor
    Prothena Biosciences Ltd.
Updated on 18 January 2022

Summary

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care compared to placebo plus standard of care in patients with AL amyloidosis in Mayo Stage IV.

Description

This is a Phase 3 multicenter, global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of birtamimab in Mayo Stage IV patients with AL amyloidosis. The primary objective is to evaluate the efficacy of birtamimab by assessing time to all-cause mortality. All patients will receive bortezomib-containing chemotherapy regimen as standard of care.

Approximately 150 newly diagnosed Mayo Stage IV patients with AL amyloidosis will be enrolled and randomized in a 2:1 ratio to birtamimab or placebo. The minimum planned treatment time for each patient is expected to be at least 9 months or until the patient's death. It is planned that all patients will continue their double-blind treatment until the last patient completes 9 months of treatment or has a mortality event.

Details
Condition Light Chain (AL) Amyloidosis
Treatment Placebo, Standard of care chemotherapy, Birtamimab
Clinical Study IdentifierNCT04973137
SponsorProthena Biosciences Ltd.
Last Modified on18 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged ≥18 years
Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement
Confirmed diagnosis of AL amyloidosis
Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and Troponin-T >0.03 ng/mL and dFLC ≥18 mg/dL
Planned first-line chemotherapy contains bortezomib administered subcutaneously weekly

Exclusion Criteria

Non-AL amyloidosis
NT-proBNP >8500 pg/mL
Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma
Subject is eligible for and plans to undergo ASCT or organ transplant during the study
Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit
Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
ECG evidence of acute ischemia or active conduction system abnormalities
Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1
Prior radiotherapy within 4 weeks of Month 1-Day 1
Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11- 1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid
Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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