A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
NCT ID: NCT00323518
Last Updated: 2016-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
390 participants
INTERVENTIONAL
2006-05-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
placebo
placebo
administered intravenously as 100mL single dose over 15 minutes on day 1
2
30 mcg/kg velafermin
velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
3
10 mcg/kg velafermin
velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
4
60 mcg/kg velafermin
velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Interventions
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velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
placebo
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with multiple myeloma or lymphoma receiving myeloablative CT with or without TBI that require autologous stem cell support. The CT regimens are limited to high dose melphalan (200 mg/m2) as a single agent, BEAM, or TBI with cyclophosphamide or VP-16.
* Adequate organ function that meets institutional requirements for autologous stem cell transplant. A minimum CD34+ cell dose of 2X106 /kg based on ideal body weight (IBW) has been or will be infused.
* ECOG Performance Score of 2 or less
* Signed Informed Consent Form (ICF)
Exclusion Criteria
* Patients diagnosed with active sero-positive acquired immunodeficiency syndrome (AIDS) or Hepatitis B/ C
* Patients with known hypersensitivity to recombinant protein therapeutics
* Patients who have taken velafermin (CG53135-05) previously
* Patients who have taken palifermin in the past 90 days
* Patients who have taken other investigational drugs in the past 30 days
* Patients who have untreated symptomatic dental infection
* Patients with a history of sensitivity or allergy to E. coli-derived products
* Patients with WHO Grade 3 or 4 OM at the time of randomization
* Patients who are sensitive or allergic to G-CSF, Fluconazole or acyclovir or equivalent
* Patients with altered mental status precluding understanding of the informed consent process and/or completion of the necessary assessments
* Patients with baseline creatinine level greater than or equal to 3 or any patient with renal insufficiency requiring dialysis.
18 Years
ALL
No
Sponsors
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CuraGen Corporation
INDUSTRY
Responsible Party
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Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Alta Bates Comprehensive Cancer Center
Berkley, California, United States
Research Facility
La Jolla, California, United States
Scripps Green Medical Center
La Jolla, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States
Emory University
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Louisiana State University Health Science Center
Shreveport, Louisiana, United States
Wayne State University
Detroit, Michigan, United States
MAYO Clinic
Rochester, Minnesota, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Cornell Medical Center
New York, New York, United States
Biomedical Research Alliance of New York
New York, New York, United States
Biomedical Research Alliance of New York
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Legacy Good Samaritan Hospital and Cancer Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Fox Chase-Temple Bone Marrow Transplant Program
Philadelphia, Pennsylvania, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Medical College of Wisonsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CG53135-CLN-12
Identifier Type: -
Identifier Source: org_study_id
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