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CAEL-101 301

Phase 3, double-blind, multicenter study to evaluate the efficacy and safety of CAEL-101 and plasma cell dyscrasia treatment compared to placebo and plasma cell dyscrasia treatment in plasma cell dyscrasia treatment-naïve patients with stage AL amyloidosis IIIb Mayo.

Project objectives

The primary objectives are:

  • To determine whether CAEL-101 and treatment for plasma cell dyscrasia improve overall survival in patients with Mayo stage IIIb AL amyloidosis who are treatment-naïve compared to treatment for plasma cell dyscrasia alone
  • To evaluate the safety and tolerability of CAEL-101 in combination with the treatment of plasma cell dyscrasia.

Start and end date

March 2022

Project Manager

Ombretta Annibali - Principal Investigator

Coordinating institution of the project

IRCCS San Matteo polyclinic in Pavia

Other Institutions involved

  • University Hospital Polyclinic of Naples 
  • Territorial Social Health Authority of the Civil Hospitals of Brescia
  • IRCCS POLICLINICO SAN MATTEO FOUNDATION - PAVIA

Funding source(s).

• Sponsored Alexion
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