Status:
COMPLETED
PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Non-Hodgkin's Lymphoma
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00352703
Start Date
April 1 2006
End Date
May 1 2007
Last Update
November 3 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.