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.