Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant

Inclusion Criteria: Male or female patients ages > 18 yrs Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation. Patients with Karnofsky performance scores > or = 70% Informed consent for participation in study Exclusion Criteria: Patients who weigh < 33 kg Premenopausal female patients who are pregnant, lactating or are likely to become pregnant Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C Patients with known hypersensitivity to recombinant protein therapeutics Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days Patients who have untreated symptomatic dental infection Patients with a history of sensitivity or allergy to E. coli-derived products Patients with WHO Grade 3 or 4 oral mucositis (OM)