125
Participants
Start Date
August 25, 2020
Primary Completion Date
May 10, 2025
Study Completion Date
October 22, 2027
CAEL-101
The investigational product, CAEL-101, is formulated as a sterile liquid solution of protein plus excipients for dilution in a single-use, stoppered, glass vial. Each 10 mL vial contains 300 mg of CAEL-101 at a concentration of 30 mg/mL. CAEL-101 will be diluted with commercially available 0.9% Normal Saline.
Placebo
Commercially available 0.9% Normal Saline will be used as the placebo.
cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen
According to institutional standard of care.
Research Site, Anderlecht
Research Site, Vienna
Research Site, Westmead
Research Site, Leuven
Research Site, Box Hill
Research Site, Linz
Research Site, Brisbane
Research Site, Barcelona
Research Site, New York
Research Site, New York
Research Site, Athens
Research Site, Prague
Research Site, Marseille
Research Site, Berlin
Research Site, Caen
Research Site, Rochester
Research Site, Philadelphia
Research Site, Hamburg
Research Site, Rio
Research Site, Pavia
Research Site, Winston-Salem
Research Site, Majadahonda
Research Site, Pamplona
Research Site, Haifa
Research Site, Toulouse
Research Site, Weston
Research Site, Gijón
Research Site, Pessac
Research Site, Rennes
Research Site, Tours
Research Site, Nashville
Research Site, Düsseldorf
Research Site, Seville
Research Site, Columbus
Research Site, Cleveland
Research Site, Essen
Research Site, Indianapolis
Research Site, Detroit
Research Site, Tel Litwinsky
Research Site, Milwaukee
Research Site, Rochester
Research Site, Pisa
Research Site, St Louis
Research Site, Heidelberg
Research Site, Pierre-Bénite
Research Site, New Orleans
Research Site, Ostrava - Poruba
Research Site, Paris
Research Site, Dallas
Research Site, Houston
Research Site, Napoli
Research Site, Salt Lake City
Research Site, Poitiers
Research Site, Limoges
Research Site, Duarte
Research Site, Jerusalem
Research Site, Créteil
Research Site, San Francisco
Research Site, Palo Alto
Research Site, Würzburg
Research Site, Portland
Research Site, Seattle
Research Site, Beijing
Research Site, Hangzhou
Research Site, Wenzhou
Research Site, Wuhan
Research Site, Guangzhou
Research Site, Boston
Research Site, Boston
Research Site, Boston
Research Site, Porto Alegre
Research Site, Ribeirão Preto
Research Site, Salvador
Research Site, São José do Rio Preto
Research Site, Calgary
Research Site, Edmonton
Research Site, Toronto
Research Site, Roma
Research Site, Fukushima
Research Site, Nagoya
Research Site, Shibuya-ku
Research Site, Groningen
Research Site, Utrecht
Research Site, Gdansk
Research Site, Poznan
Research Site, Warsaw
Research Site, Seoul
Research Site, Seoul
Research Site, Barcelona
Research Site, London
Lead Sponsor
Alexion Pharmaceuticals, Inc.
INDUSTRY