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Clinical Trial 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 Mayo Stage IV patients with AL amyloidosis.


Clinical Trial 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 (i.e., Double-blind Phase), followed by a long-term, open-label extension (i.e., Open-label Extension [OLE] Phase). The primary objective of the Double-blind Phase 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. For the Double-blind Phase of the study, approximately 220 newly diagnosed Mayo Stage IV patients with AL amyloidosis will be enrolled and randomized in a 2:1 ratio to birtamimab or placebo. Subjects will remain on study until study completion, when the pre-defined number of events (all-cause mortality) have been reached. After completion of the Double-blind Phase, eligible subjects may enter the optional OLE Phase, in which all subjects will receive open-label birtamimab treatment, regardless of Double-blind Phase randomized treatment assignment. Treatment in the OLE Phase will continue for an additional 24 months or until birtamimab is commercially available in a subject's country of residence, whichever occurs first (in accordance with country-specific regulations). The primary objective of the OLE Phase is to evaluate the long-term safety of birtamimab plus standard of care in Mayo Stage IV subjects with AL amyloidosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04973137
Study type Interventional
Source Prothena Biosciences Ltd.
Contact Sonia Romero
Phone 650-837-8550
Email AFFIRM-ALClinicalTrial@prothena.com
Status Recruiting
Phase Phase 3
Start date August 30, 2021
Completion date June 2027

See also
  Status Clinical Trial Phase
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Withdrawn NCT05692908 - An Open-Label Study of the Safety of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With AL Amyloidosis Phase 1
Withdrawn NCT04943302 - Isatuximab and Bendamustine in Systemic Light Chain Amyloidosis Phase 2
Not yet recruiting NCT06097832 - Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis Phase 1
Recruiting NCT05486481 - Venetoclax, Daratumumab, and Dexamethasone for Systemic Light-Chain Amyloidosis With Translocation (11;14) (ALTITUDE) Phase 1/Phase 2
Recruiting NCT06376214 - Daratumumab for Patients With Light Chain Amyloidosis N/A
Completed NCT02015312 - A Trial for the Treatment of Cardiac AL-Amyloidosis With the Green Tea Compound Epigallocatechin-3-gallate (TAME-AL) Phase 2
Recruiting NCT04316442 - Study of the Safety and Efficacy of STI-6129 in Patients With Relapsed or Refractory Systemic AL Amyloidosis Phase 1/Phase 2