UARK 2006-21: A Single-Center, Open-Label, Randomized, Phase 1B Study Evaluating the Safety and Tolerability of Intravenous Recombinant Human Mannose-Binding Lectin (rhMBL) in the Treatment of Patients With Multiple Myeloma Receiving Melphalan-Based High-Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Transplant
Sponsor:
Enzon Pharmaceuticals, Inc.
PI:
Elias Anaissie, M.D.
Phase:
1B
Purpose:
The purpose of this research study is for the sponsor, Enzon Pharmaceuticals, Inc. (“Enzon”), to learn more about its drug, recombinant human mannose-binding lectin (rhMBL). rhMBL is an investigational drug (not yet approved by the United States Food and Drug Administration [FDA]).
Eligibility:
You are being asked to take part in this study because you have multiple myeloma and you have already received one or more treatment regimens.
Treatment:
You will receive rhMBL as part of this study. The rhMBL is given through a needle into your vein, also known as an intravenous (i.v.) infusion. The rhMBL infusion takes 60 minutes (1 hour). rhMBL will be given to you once every week for 4 weeks in a row. The study will last about 3 to 5 months, consisting of tests before you receive rhMBL, 4 weekly treatments with rhMBL that will last about 1 month, and a 6- to 10-week follow-up after the last treatment with rhMBL.
