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
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.