Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)

This study has been completed.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier:
NCT00109031
First received: April 22, 2005
Last updated: July 13, 2012
Last verified: July 2012

April 22, 2005
July 13, 2012
January 2005
February 2006   (final data collection date for primary outcome measure)
Includes incidence of severe oral mucositis (OM), duration of severe OM, Patient-reported outcome (PRO) daily assessments of mouth and throat soreness, use of parenteral or transdermal opioid analgesics [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00109031 on ClinicalTrials.gov Archive Site
Not Provided
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Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
A Randomized, Blinded, Active-control Trial of Palifermin (rHuKGF) to Evaluate Oral Mucositis in Subjects With Hematologic Malignancies Undergoing Fractionated Total Body Irradiation (fTBI) and High Dose Chemotherapy With Autologous Peripheral Blood Progenitor Cell (PBPC) Transplantation

To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization [WHO] grade 3 and 4).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
  • Cancer
  • Lymphoma
  • Leukemia
  • Drug: palifermin
    palifermin 180 mcg/kg 3 days prior to fTBI and placebo the 2 days after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2
  • Drug: palifermin
    palifermin 60 mcg/kg on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2
  • Drug: Palifermin
    palifermin 180 mcg/kg 1 day prior to fTBI and placebo on the 2 days prior to the 180 mcg/kg dose and palifermin 60 mcg mcg/kg on days 0, 1 and 2
  • Drug: palifermin
    palifermin 180 mcg/kg 2 days prior to fTBI and placebo the day before and after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2
  • Arm C
    palifermin 180 mcg/kg 2 days prior to fTBI and placebo the day before and after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
    Intervention: Drug: palifermin
  • Arm D
    palifermin 180 mcg/kg 3 days prior to fTBI and placebo the 2 days after the 180 mcg/kg dose and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
    Intervention: Drug: palifermin
  • Arm A
    palifermin 60 mcg/kg on the 3 days prior to fTBI and palifermin 60 mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
    Intervention: Drug: palifermin
  • Arm B
    palifermin 180 mcg/kg 1 day prior to fTBI and placebo on the 2 days prior to the 180 mcg/kg dose and palifermin 60 mcg mcg/kg on days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC)
    Intervention: Drug: Palifermin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
47
December 2010
February 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • Subjects with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma
  • Minimum of 1.5 x 10^6 CD34+ cells/kg cryopreserved and to be transplanted.

Exclusion Criteria:

  • Cancer other than those specified in inclusion criteria above (except: adequately treated basal cell carcinoma of the skin)
  • Prior bone marrow or peripheral blood stem cell transplantation - Negatively selected (purged) stem cell product - Current active infection or oral mucositis
  • Congestive heart failure as defined by New York Heart Association class III or IV.
  • History of or current diagnosis of pancreatitis
  • Inadequate renal function (serum creatinine greater than 1.5x the upper limit of normal per the institutional guidelines)
  • Inadequate liver function (direct bilirubin greater than 1.5x the upper limit of normal, AST greater than 3x upper limit of normal and/or ALT greater than 3x upper limit of normal per the institutional guidelines)
  • Inadequate pulmonary function as measured by a corrected DLCO less than 50% of predicted.
  • Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00109031
20040212
Yes
Swedish Orphan Biovitrum
Swedish Orphan Biovitrum
Amgen
Study Director: MD Amgen
Swedish Orphan Biovitrum
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP