NCT00352703CompletedPhase 4
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
Swedish Orphan Biovitrum0 sites145 target enrollmentStarted: April 2006Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 145
- Primary Endpoint
- The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 <=
- •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.
Arms & Interventions
Kepivance (palifermin) 60 μg/kg/day IV
Experimental
60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation.
Intervention: Kepivance (Palifermin) (Drug)
Outcomes
Primary Outcomes
The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).
Time Frame: Up to 40 days
The study consisted of a screening period of up to 42 days to determine subject eligibility, followed by a treatment period of a maximum of 40 days.
Secondary Outcomes
No secondary outcomes reported
Investigators
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