Safety and tolerability of velafermin (CG53135-05) in patients receiving high-dose chemotherapy and autologous peripheral blood stem cell transplant |
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Authors: | Michael W Schuster Tsiporah B Shore John G Harpel June Greenberg Bita Jalilizeinali Scott Possley Robert W Gerwien William Hahne Yuan-Di C Halvorsen |
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Institution: | (1) New York-Presbyterian Hospital and The Weill Medical College of Cornell University, 525 East 70th Street, New York, NY 10021, USA;(2) CuraGen Corporation, 322 East Main Street, Branford, CT 06405, USA |
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Abstract: | Goals of work The objective of this study was to evaluate the safety and tolerability of velafermin in patients at risk of developing severe
oral mucositis (OM) from chemotherapy.
Materials and methods This study was a single-center, open-label, single-dose escalation, phase I trial in patients undergoing high-dose chemotherapy
(HDCT) and autologous peripheral blood stem cell transplant (PBSCT). Velafermin was administered 24 h after stem cell infusion
as a single intravenous dose infused over 15 min. Clinical safety variables were assessed and OM status scored daily for 30 days
using the World Health Organization (WHO) grading scale.
Main results Thirty patients were treated with velafermin at doses of 0.03 (n = 10), 0.1 (n = 10), 0.2 (n = 8), or 0.33 mg/kg (n = 2). Patients were diagnosed with multiple myeloma (n = 16), non-Hodgkin’s lymphoma (n = 12), acute myelogenous leukemia (n = 1), or desmoplasmic round cell tumor (n = 1). Velafermin was well tolerated at doses up to 0.2 mg/kg. There were no drug-related serious adverse events. No patient
discontinued because of adverse events; however, two patients administered 0.33 mg/kg developed adverse reactions immediately
after infusion of the study drug. No other patients were treated at this dose level. The most frequent (>35% of patients)
treatment-emergent adverse events were diarrhea, fatigue, pyrexia, vomiting, and nausea. Most adverse events were mild or
moderate and resolved the same day without sequelae. Eight (27%) patients developed WHO grade 3 or 4 OM during the study;
seven of these patients received high-dose melphalan as a conditioning regimen.
Conclusion Velafermin was well tolerated by autologous PBSCT patients at doses up to 0.2 mg/kg. |
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Keywords: | Oral mucositis Cancer supportive care Velafermin CG53135 Autologous stem cell transplant |
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