Clinical trial NCT00352703: PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma
Multiple Myeloma
Keywords: Oral mucositis
Non-Hodgkin's lymphoma (NHL)
conditioning chemotherapy
autologous PBSCT
multiple myeloma (MM)
Melphalan
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).
timeFrame: Up to 40 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Biovitrum AB
name: MD
role: STUDY_DIRECTOR
References: