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PROMPT - Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

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ClinicalTrials.gov Identifier: NCT00352703
Recruitment Status : Completed
First Posted : July 17, 2006
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Multiple Myeloma Drug: Kepivance (Palifermin) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Palifermin
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352703


Sponsors and Collaborators
Swedish Orphan Biovitrum
Investigators
Study Director: MD Biovitrum AB

Additional Information:
Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT00352703     History of Changes
Other Study ID Numbers: 20050100
First Posted: July 17, 2006    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

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
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Mucositis
Stomatitis
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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases