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: September 12, 2014
Last verified: September 2014
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Supportive Care
Conditions: Cancer
Lymphoma
Leukemia
Interventions: Drug: palifermin
Radiation: Total Body Irradiation
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Palifermin 60 µg/kg for 3 Days Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Palifermin 180 μg/kg on Day −1 Palifermin 180 μg/kg on Day −1 and matched placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Palifermin 180 μg/kg on Day −2 Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
Palifermin 180 μg/kg on Day −3 Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.

Participant Flow:   Overall Study
    Palifermin 60 µg/kg for 3 Days     Palifermin 180 μg/kg on Day −1     Palifermin 180 μg/kg on Day −2     Palifermin 180 μg/kg on Day −3  
STARTED     11     10     14     12  
COMPLETED     11     8     12     12  
NOT COMPLETED     0     2     2     0  
Adverse Event                 0                 0                 1                 0  
Withdrawal by Subject                 0                 1                 0                 0  
Physician Decision                 0                 1                 0                 0  
Protocol Violation                 0                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Primary Analysis Set (all randomized participants who signed informed consent before invasive, protocol-specified procedures).

Reporting Groups
  Description
Palifermin 60 µg/kg for 3 Days Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
Palifermin 180 μg/kg on Day −1 Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Palifermin 180 μg/kg on Day −2 Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Palifermin 180 μg/kg on Day −3 Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
Total Total of all reporting groups

Baseline Measures
    Palifermin 60 µg/kg for 3 Days     Palifermin 180 μg/kg on Day −1     Palifermin 180 μg/kg on Day −2     Palifermin 180 μg/kg on Day −3     Total  
Number of Participants  
[units: participants]
  11     10     13     12     46  
Age  
[units: years]
Mean ± Standard Deviation
  52.7  ± 9.9     49.7  ± 9.7     47.4  ± 14.2     46.1  ± 13.8     48.8  ± 12.2  
Gender  
[units: participants]
         
Female     5     0     4     2     11  
Male     6     10     9     10     35  
Race/Ethnicity, Customized  
[units: participants]
         
White or Caucasian     11     8     12     10     41  
Black or African American     0     2     1     1     4  
Hispanic or Latino     0     0     0     1     1  
Type of diagnosis [1]
[units: participants]
         
Hodgkin's disease     0     1     4     4     9  
Non-Hodgkin's lymphoma     9     9     9     6     33  
Multiple Myeloma     0     0     0     0     0  
Leukemia     2     0     0     2     4  
Acute lymphoblastic leukemia     1     0     0     0     1  
Acute myelogenous leukemia     1     0     0     1     2  
Chronic lymphocytic leukemia     0     0     0     1     1  
Chronic myelogenous leukemia     0     0     0     0     0  
Etoposide use  
[units: participants]
         
Yes     9     10     11     11     41  
No     2     0     2     1     5  
Number of days of total body irradiation [2]
[units: participants]
         
≤ 2 days     0     1     1     0     2  
3 days     4     4     6     4     18  
4 days     6     6     6     8     26  
≥ 5 days     0     0     0     0     0  
[1] Acute lymphoblastic leukemia., Acute myelogenous leukemia, Chronic lymphocytic leukemia, and1 ( 8) Chronic myelogenous leukemia are subsets of Leukemia.
[2] Data are reported for the safety analysis set, as treated. Seven participants received the wrong sequence of placebo and palifermin in error in. Consequently, 10, 11, 13, and 12 participants actually received treatment according in each treatment arm respectively.



  Outcome Measures
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1.  Primary:   Number of Participants With Severe Oral Mucositis (WHO Grade 3 and 4)   [ Time Frame: Up to Day 28 ]

2.  Secondary:   Duration of Severe Oral Mucositis (WHO Grade 3 and 4)   [ Time Frame: Up to Day 28 ]

3.  Secondary:   Area Under the Curve (AUC) of Mouth and Throat Soreness Score   [ Time Frame: From the first day of study drug administration through Day 28 ]

4.  Secondary:   Number of Participants With Parenteral or Transdermal Opioid Analgesic Use   [ Time Frame: Up to Day 28 ]

5.  Secondary:   Number of Participants With WHO Grades 2, 3 or 4 Oral Mucositis   [ Time Frame: Up to Day 28 ]

6.  Secondary:   Duration of WHO Grade 2, 3 or 4 Oral Mucositis   [ Time Frame: Up to Day 28 ]

7.  Secondary:   Number of Participants With WHO Grade 4 Oral Mucositis   [ Time Frame: Up to Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Hans Olivecrona, MD PhD
Organization: Swedish Orphan Biovitrum
phone: +46 8 697 20 00
e-mail: hans.olivecrona@sobi.com


No publications provided


Responsible Party: Swedish Orphan Biovitrum
ClinicalTrials.gov Identifier: NCT00109031     History of Changes
Obsolete Identifiers: NCT00126529, NCT00965692
Other Study ID Numbers: 20040212
Study First Received: April 22, 2005
Results First Received: January 24, 2014
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration