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

A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant

CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing 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.