Last updated on April 2018

Renal AL Amyloid Involvement and NEOD001


Brief description of study

This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who have a maintained hematologic response to their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent renal dysfunction.

Detailed Study Description

This is a multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who have a maintained hematologic response to their most recent treatment for AL amyloidosis (e.g., chemotherapy, autologous stem cell transplant [SCT]) and have persistent renal dysfunction. Subject screening will occur during the 28 days prior to the first administration of study drug (i.e. month 1 day 1). If screening assessments are completed and all eligibility requirements are met, the subject will be enrolled. 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 may receive up to 12 infusions of study drug. Subjects who discontinue study drug before the initial End of Study (EOS) visit should have an Early Treatment Discontinuation (ETD) Visit 30 (5) days after their final administration of study drug. After completing 12 months of treatment and the confirmatory EOS visit, a subject may enter an open-label extension (OLE) study, during which subjects will receive active treatment with NEOD001 for 12 months and may receive concurrent chemotherapy.

Clinical Study Identifier: NCT03168906

Contact Investigators or Research Sites near you

Start Over

Joseph Mikhael, MD

Mayo Clinic- Arizona
Scottsdale, AZ United States

Sandy Wong, MD

University of California San Francisco
San Francisco, CA United States

Taimur Sher, MD

Mayo Clinic- Florida
Jacksonville, FL United States

Cindy Varga, MD

Tufts Medical Center
Boston, MA United States

Jeff 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

Brendan Weiss, MD

Hospital of the University of Pennsylvania
Philadelphia, PA United States

Stacey Goodman, MD

Vanderbilt University Medical Center
Nashville, TN United States