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Brief Title: A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis
Official Title: A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIb AL Amyloidosis
Study ID: NCT04504825
Brief Summary: 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 and it is safe and well tolerated in patients with stage IIIb AL amyloidosis.
Detailed Description: This is a double-blind, randomized, multicenter international Phase 3 study of CAEL-101 combined with standard of care (SoC) plasma cell dyscrasia (PCD) treatment versus placebo combined with SoC PCD treatment in Mayo stage IIIb PCD treatment-naïve AL amyloidosis patients. As this is an event-driven study, the study will enroll until at least 101 deaths have been observed. Approximately 124 patients will be enrolled using a 2:1 randomization ratio. Stratification will be based on geographic region across investigator sites. An interim analysis (IA) may be performed when approximately 75% (76/101) of the expected deaths has been observed. Patients in both study intervention groups will be followed from randomization until death from any cause or until the end of study.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Clinical Trial Site, Phoenix, Arizona, United States
Clinical Trial Site, Scottsdale, Arizona, United States
Clinical Trial Site, Duarte, California, United States
Clinical Trial Site, San Francisco, California, United States
Clinical Trial Site, Stanford, California, United States
Clinical Trial Site, Jacksonville, Florida, United States
Clinical Trial Site, Weston, Florida, United States
Clinical Trial Site, Indianapolis, Indiana, United States
Clinical Trial Site, New Orleans, Louisiana, United States
Clinical Trial Site, Baltimore, Maryland, United States
Clinical Trial Site, Boston, Massachusetts, United States
Clinical Trial Site, Boston, Massachusetts, United States
Clinical Trial Site, Boston, Massachusetts, United States
Clinical Trial Site, Detroit, Michigan, United States
Clinical Trial Site, Rochester, Minnesota, United States
Clinical Trial Site, Saint Louis, Missouri, United States
Clinical Trial Site, New York, New York, United States
Clinical Trial Site, New York, New York, United States
Clinical Trial Site, New York, New York, United States
Clinical Trial Site, Rochester, New York, United States
Clinical Trial Site, Chapel Hill, North Carolina, United States
Clinical Trial Site, Durham, North Carolina, United States
Clinical Trial Site, Winston-Salem, North Carolina, United States
Clinical Trial Site, Cleveland, Ohio, United States
Clinical Trial Site, Columbus, Ohio, United States
Clinical Trial Site, Portland, Oregon, United States
Clinical Trial Site, Philadelphia, Pennsylvania, United States
Clinical Trial Site, Nashville, Tennessee, United States
Clinical Trial Site, Dallas, Texas, United States
Clinical Trial Site, Houston, Texas, United States
Clinical Trial Site, Salt Lake City, Utah, United States
Clinical Trial Site, Seattle, Washington, United States
Clinical Trial Site, Milwaukee, Wisconsin, United States
Clinical Trial Site, Adelaide, , Australia
Clinical Trial Site, Brisbane, , Australia
Clinical Trial Site, Murdoch, , Australia
Clinical Trial Site, Sydney, , Australia
Clinical Trial Site, Linz, , Austria
Clinical Trial Site, Linz, , Austria
Clinical Trial Site, Bruxelles, , Belgium
Clinical Trial Site, Bruxelles, , Belgium
Clinical Trial Site, Leuven, , Belgium
Clinical Trial Site, Porto Alegre, , Brazil
Clinical Trial Site, Recife, , Brazil
Clinical Trial Site, Ribeirao Preto, , Brazil
Clinical Trial Site, Santo Amaro, , Brazil
Clinical Trial Site, Sao Paulo, , Brazil
Clinical Trial Site, São José do Rio Preto, , Brazil
Clinical Trail Site, São Paulo, , Brazil
Clinical Trial Site, Calgary, Alberta, Canada
Clinical Trial Site, Edmonton, Alberta, Canada
Clinical Trial Site, Toronto, Ontario, Canada
Clinical Trial Site, Beijing, Beijing, China
Clinical Trial Site, Guangzhou, Guangzhou, China
Clinical Trial Site, Hangzhou, Hangzhou, China
Clinical Trial Site, Beijing, , China
Clinical Trial Site, Beijing, , China
Clinical Trial Site, Hangzhou, , China
Clinical Trial Site, Shanghai, , China
Clinical Trial Site, Suzhou, , China
Clinical Trial Site, Wenzhou, , China
Clinical Trial Site, Wuhan, , China
Clinical Trial Site, Ostrava, , Czechia
Clinical Trial Site, Caen, , France
Clinical Trial Site, Créteil, , France
Clinical Trial Site, Dijon, , France
Clinical Trial Site, Lille, , France
Clinical Trial Site, Limoges, , France
Clinical Trial Site, Marseille, , France
Clinical Trial Site, Paris, , France
Clincal Trial Site, Pessac, , France
Clinical Trial Site, Pierre-Bénite, , France
Clinical Trial Site, Poitiers, , France
Clinical Trial Site, Rennes, , France
Clinical Trial Site, Toulouse, , France
Clinical Trial Site, Tours, , France
Clinical Trial Site, Berlin, , Germany
Clinical Trial Site, Düsseldorf, , Germany
Clinical Trial Site, Essen, , Germany
Clinical Trial Site, Hamburg, , Germany
Clinical Trial Site, Heidelberg, , Germany
Clinical Trial Site, Würzburg, , Germany
Clinical Trial Site, Athens, , Greece
Clinical Trial Site, Patras, , Greece
Clinical Trial Site, Thessaloníki, , Greece
Clinical Trial Site, Haifa, , Israel
Clinical Trial Site, Jerusalem, , Israel
Clinical Trial Site, Petah Tikva, , Israel
Clinical Trial Site, Ramat Gan, , Israel
Clinical Trial Site, Tel Aviv, , Israel
Clinical Trial Site, Brescia, , Italy
Clinical Trial Site, Naples, , Italy
Clinical Trial Site, Pavia, , Italy
Clinical Trial Site, Rome, , Italy
Clinical Trial Site, Kumamoto-shi, Kumamoto, Japan
Clinical Trial Site, Fukushima, , Japan
Clinical Trial Site, Nagoya, , Japan
Clinical Trial Site, Tokyo, , Japan
Clinical Trial Site, Seoul, , Korea, Republic of
Clinical Trial Site, Seoul, , Korea, Republic of
Clinical Trial Site, Seoul, , Korea, Republic of
Clinical Trial Site, Seoul, , Korea, Republic of
Clinical Trial Site, Amsterdam, , Netherlands
Clinical Trial Site, Groningen, , Netherlands
Clinical Trial Site, Utrecht, , Netherlands
Clinical Trial Site, Gdansk, , Poland
Clinical Trial Site, Poznan, , Poland
Clinical Trial Site, Warszawa, , Poland
Clinical Trial Site, Moscow, , Russian Federation
Clinical Trial Site, Saint Petersburg, , Russian Federation
Clinical Trial Site, Saint Petersburg, , Russian Federation
Clinical Trial Site, Barcelona, , Spain
Clinical Trial Site, Barcelona, , Spain
Clinical Trial Site, Gijon, , Spain
Clinical Trial Site, Granada, , Spain
Clinical Trial Site, Madrid, , Spain
Clinical Trial Site, Madrid, , Spain
Clinical Trial Site, Madrid, , Spain
Clinical Trial Site, Pamplona, , Spain
Clinical Trial Site, Salamanca, , Spain
Clinical Trial Site, Sevilla, , Spain
Clinical Trial Site, Valencia, , Spain
Clinical Trial Site, Bern, , Switzerland
Clinical Trial Site, Glasgow, , United Kingdom
Clinical Trial Site, London, , United Kingdom
Name: Scott Swenson, MD
Affiliation: Alexion, AstraZeneca Rare Disease
Role: STUDY_DIRECTOR