メイヨーステージIIIb ALアミロイドーシス患者におけるCAEL-101の有効性と安全性を評価する研究（CARES）

基本情報

NCT ID: NCT04504825
ステータス: 実施中（募集終了）
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 125
治験依頼者名: Alexion Pharmaceuticals, Inc.

概要

AL (or light chain) amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine whether CAEL-101, a monoclonal antibody that removes AL amyloid deposits from tissues and organs, improves overall survival, reduces cardiovascular related hospitalizations and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.

対象疾患

ALアミロイドーシス

介入

CAEL-101(DRUG)

Placebo(OTHER)

cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen(DRUG)

依頼者（Sponsor）

アレクシオンファーマ合同会社(INDUSTRY)