PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation - Full Text View

Sponsor:	Swedish Orphan Biovitrum
Information provided by:	Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:	NCT00352703

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma Multiple Myeloma	Drug: Kepivance (Palifermin)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Lymphoma Multiple Myeloma

Drug Information available for: Palifermin

U.S. FDA Resources

Further study details as provided by Swedish Orphan Biovitrum:

Primary Outcome Measures:

The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4). [ Time Frame: Up to 40 days ] [ Designated as safety issue: No ]
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.

Enrollment:	145
Study Start Date:	April 2006
Study Completion Date:	May 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Kepivance (palifermin) 60 μg/kg/day IV 60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation.	Drug: Kepivance (Palifermin)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352703

Sponsors and Collaborators

Swedish Orphan Biovitrum

Investigators

Study Director:

MD

Biovitrum AB

More Information

Additional Information:

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical Development, Biovitrum AB (publ)
ClinicalTrials.gov Identifier:	NCT00352703 History of Changes
Other Study ID Numbers:	20050100
Study First Received:	July 13, 2006
Last Updated:	August 30, 2010
Health Authority:	Spain: Ministry of Health and Consumption

Keywords provided by Swedish Orphan Biovitrum:

Oral mucositis
Non-Hodgkin's lymphoma (NHL)
conditioning chemotherapy

autologous PBSCT
multiple myeloma (MM)
Melphalan

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Stomatitis
Mucositis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012