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PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation
This study has been completed.
First Received: July 13, 2006   Last Updated: February 27, 2009   History of Changes
Sponsor: Biovitrum
Information provided by: 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: Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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:


Further study details as provided by Biovitrum:

Primary Outcome Measures:
  • The primary efficacy endpoints are the incidence (%) and duration of severe oral mucositis (WHO grades 3 or 4).

Estimated Enrollment: 150
Study Start Date: April 2006
  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
Biovitrum
Investigators
Study Director: MD Biovitrum AB
  More Information

Additional Information:
No publications provided

Responsible Party: Biovitrum AB (publ) ( Clinical Development )
Study ID Numbers: 20050100
Study First Received: July 13, 2006
Last Updated: February 27, 2009
ClinicalTrials.gov Identifier: NCT00352703     History of Changes
Health Authority: Spain: Spanish Agency of Medicine and Health Products

Keywords provided by Biovitrum:
Oral mucositis
Non-Hodgkin's lymphoma (NHL)
conditioning chemotherapy
autologous PBSCT
multiple myeloma (MM)
Melphalan

Additional relevant MeSH terms:
Mouth Diseases
Neoplasms by Histologic Type
Immunoproliferative Disorders
Mucositis
Stomatitis
Immune System Diseases
Gastrointestinal Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Hemorrhagic Disorders
Cardiovascular Diseases
Stomatognathic Diseases
Gastroenteritis
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on February 09, 2010