Clinical trial NCT00109031: Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Lymphoma
Leukemia
Keywords: Cancer
Oncology
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2005-04-25
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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, aspartate aminotransferase (AST) greater than 3x upper limit of normal and/or alanine aminotransferase (ALT) greater than 3x upper limit of normal per the institutional guidelines)
* Inadequate pulmonary function as measured by a corrected diffusion capacity of carbon monoxide (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)

Primary outcomes:
measure: Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)
timeFrame: Up to Day 28
Secondary outcomes:
measure: Duration of Severe Oral Mucositis (WHO Grade 3 and 4)
timeFrame: Up to Day 28
measure: Area Under the Curve (AUC) of Mouth and Throat Soreness Score
timeFrame: From the first day of study drug administration through Day 28
measure: Number of Participants With Parenteral or Transdermal Opioid Analgesic Use
timeFrame: Up to Day 28
measure: Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis
timeFrame: Up to Day 28
measure: Duration of WHO Grade 2, 3 or 4 Oral Mucositis
timeFrame: Up to Day 28
measure: Number of Participants With WHO Grade 4 Oral Mucositis
timeFrame: Up to Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: