PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

An Open-label, Single-arm Study of Palifermin for Reduction of Mucositis in Subjects With Non-Hodgkin's Lymphoma or Multiple Myeloma Undergoing High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell (PBSC) Transplantation

This is an open-label, single-arm, multicentre study conducted in Spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day IV for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous PBSCT for treating oral mucositis in patients with NHL and MM who have received high-dose conditioning chemotherapy.

Inclusion Criteria:

• Non-Hodgkin's lymphoma (NHL) subjects scheduled to receive BEAM conditioning chemotherapy followed by autologous PBSCT, or multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous PBSCT
• ≥Age 18 years
• ECOG performance status <= 2. In the MM group, ECOG status >2 will be accepted provided that it is exclusively due to MM (e.g. pathological fracture)
• Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) ≥ 60% of predicted
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Minimum of 1.5 x 10^6 CD34+ cells/kg for autologous transplantation
• Adequate haematological function (ANC ≥ 1.5 x 10^9/L and platelet count ≥ 100 x 10^9/L)
• Serum creatinine <= 2.0 mg/dL
• Total bilirubin <= 2 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 4.0 x IULN
• Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment
• Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. Exclusion Criteria:
• History of or concurrent cancer other than NHL or MM
• Prior treatment with palifermin, or other keratinocyte growth factors (eg, KGF-2)- Prior autologous or allogeneic transplants
• Oral abnormalities defined as baseline oral assessment of WHO grade >0
• Other investigational procedures are excluded
• Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
• Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
• Subject is not using adequate contraceptive precautions
• Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products
• Subject has previously been treated on this study or with other keratinocyte growth factors
• Unwilling or unable to complete the patient-reported outcome questionnaires
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.