A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

Inclusion Criteria: * Age 18 years or older * Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16. * Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused. * ECOG Performance Score of 2 or less * Signed Informed Consent Form (ICF) Exclusion Criteria: * Premenopausal female patients who are pregnant, lactating or are likely to become pregnant * Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C * Patients with known hypersensitivity to recombinant protein therapeutics * Patients who have taken velafermin (CG53135-05) previously * Patients who have taken palifermin in the past 90 days * Patients who have taken 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 OM at the time of randomization * Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent * Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments * Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.