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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 22, 2005

Last Updated Date

July 13, 2012

Start Date ^ICMJE

January 2005

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00109031 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Condition ^ICMJE

Cancer
Lymphoma
Leukemia

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00109031

Other Study ID Numbers ^ICMJE

20040212

Has Data Monitoring Committee

Yes

Responsible Party

Swedish Orphan Biovitrum

Study Sponsor ^ICMJE

Swedish Orphan Biovitrum

Collaborators ^ICMJE

Amgen

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Swedish Orphan Biovitrum

Verification Date

July 2012

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

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