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Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis

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Trial Identification

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

Conditions

AL Amyloidosis

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Scott Swenson, MD

Affiliation: Alexion, AstraZeneca Rare Disease

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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