Last updated on June 2018

Study in Subjects With Light Chain (AL) Amyloidosis


Brief description of study

The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who have completed Study NEOD001-201.

Detailed Study Description

Global, multicenter, Phase 2b, open-label extension study of subjects with AL amyloidosis who had a hematologic response to first-line treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and completed Study NEOD001-201. Subjects in this study may receive concomitant chemotherapy. Subject screening will occur during the 28 days prior to the first administration of study drug, which may overlap with the last visit in Study NEOD001-201. If all eligibility requirements are met, the subject will be enrolled and Screening assessments will be completed. Study visits will occur every 28 days based on scheduling from Month 1 Day 1. A 5-day window is allowed for visits starting after Month 1. Subjects who discontinue study drug before the End of Study Visit (EOS) should have an Early Treatment Discontinuation Visit 30 (5) days after their final administration of study drug. Each subject's study participation may be up to 38 months or until the study is terminated, whichever occurs first. The study consists of a Screening Phase (1 month), Treatment Phase (36 months), and EOS Visit (30 [5] days after the last dose).

Clinical Study Identifier: NCT03154047

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Tara Gregory, MD

Colorado Blood Cancer Institute
Denver, CO United States

Taimur Sher, MD

Mayo Clinic Hospital - Florida
Jacksonville, FL United States

Raymond Comenzo, MD

Tufts Medical Center
Boston, MA United States

Jeffrey Zonder, MD

Karmanos Cancer Institute
Detroit, MI United States

Morie Gertz, MD

Mayo Clinic - Minnesota
Rochester, MN United States

Heather Landau, MD

Memorial Sloan-Kettering Cancer Center
New York, NY United States

Jason Valent, MD

Cleveland Clinic
Cleveland, OH United States

Stephen Heitner, MD

Oregon Health & Science University
Portland, OR United States

Adam Cohen, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States

Stacey Goodman, MD

Vanderbilt University Medical Center
Nashville, TN United States

Hans Lee, MD

The University of Texas MD Anderson Cancer Center
Houston, TX United States

Anita D'Souza, MD

Medical College of Wisconsin
Milwaukee, WI United States

Fiona Kwok, MD

Westmead Hospital
Sydney, Australia

Peter Mollee, MD

Princess Alexandra Hospital
Woolloongabba, Australia

Simon Gibbs, MD

Eastern Health (Box Hill Hospital)
Box Hill, Australia

Hermine Agis, MD

Medizinische Universit t Wien
Vienna, Austria

Arnaud Jaccard, MD

H pital Dupuytren - CHU Limoges
Limoges, France

Sylvain Choquet, MD

H pital Piti -Salp tri re
Paris, France

Axel Nogai, MD

Charit - Universit tsmedizin Berlin
Berlin, Germany

Alexander Carpinteiro, MD

University of Duisburg-Essen
Essen, Germany

Mascha Binder, MD

Universit tsklinikum Hamburg-Eppendorf (UKE)
Hamburg, Germany

Michael Rosenzweig, MD

City of Hope
Duarte, CA United States

Andrzej Jakubowiak, MD

University of Chicago Medicine
Chicago, IL United States

Rafat Abonour, MD

Indiana University Simon Cancer Center
Indianapolis, IN United States

Cristina Gasparetto, MD

Duke University Medical Center
Durham, NC United States

Stefan Schönland, MD

Universit tsklinikum Heidelberg
Heidelberg, Germany

Efstathios Kastritis, MD

Alexandra General Hospital of Athens
Athens, Greece

Anargyros Symeonidis, MD

University Hospital of Patras
Patras, Greece

Moshe Gatt, MD

Hadassah Medical Center (HMC)
Jerusalem, Israel

Giampaolo Merlini

Fondazione IRCCS Policlinico San Matteo
Pavia, Italy

Joan Blade, MD

Hospital Cl nic de Barcelona
Barcelona, Spain

Isabel Krsnik

Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Spain

Guy Pratt, MD

Queen Elizabeth Hospital
Birmingham, United Kingdom

Ashutosh Wechalekar, MD

The Royal Free Hospital
London, United Kingdom