Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Swedish Orphan Biovitrum
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
Clareo Health | PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
