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.