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A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant

Phase 2
18 Years
Not Enrolling
Oral Mucositis, Stomatitis

Thank you

Trial Information

A Phase II Randomized Double Blind Placebo Controlled Trial to Assess Safety and Efficacy of Velafermin for Prevention of Oral Mucositis in Hematologic Cancer Patients Receiving Autologous Stem Cell Transplant

Inclusion Criteria:

- Age 18 years or older

- 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

- 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:

- Premenopausal female patients who are pregnant, lactating or are likely to become

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

the incidence of grade 3/4 oral mucositis using WHO grading system

Outcome Time Frame:

evaluated throughout the study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

August 2008

Related Keywords:

  • Oral Mucositis
  • Stomatitis
  • oral mucositis
  • hematologic
  • autologous stem cell transplant
  • velafermin
  • stomatitis
  • oncology - supportive care
  • mouth diseases
  • Stomatitis
  • Mucositis



Mayo Clinic Rochester, Minnesota  55905
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
University Hospitals of Cleveland Cleveland, Ohio  44106
Rush University Medical Center Chicago, Illinois  60612-3824
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Roger Williams Medical Center Providence, Rhode Island  02908-4735
Cancer Center at Hackensack University Medical Center Hackensack, New Jersey  07601
Baylor University Medical Center Dallas, Texas  75246
Alta Bates Comprehensive Cancer Center Berkeley, California  94704
St. Francis Hospital and Health Centers Beech Grove, Indiana  46107
University of Oklahoma Oklahoma City, Oklahoma  73190
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
Northwestern University Chicago, Illinois  60611
University of Colorado Health Sciences Center Denver, Colorado  80262
Cornell Medical Center New York, New York  10021
Emory University Atlanta, Georgia  30322
Wayne State University Detroit, Michigan  48202
University of Texas Health Science Center San Antonio, Texas  78284
Oregon Health and Science University Portland, Oregon  97201
Louisiana State University Health Science Center New Orleans, Louisiana  70112
Biomedical Research Alliance of New York New York, New York  10016
Medical University of South Carolina Hollings Cancer Center Charleston, South Carolina  29425
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Rocky Mountain Blood and Marrow Transplant Program Denver, Colorado  80218
Research Facility La Jolla, California  92037
Scripps Green Medical Center La Jolla, California  92037
Legacy Good Samaritan Hospital and Cancer Center Portland, Oregon  97227
Fox Chase-Temple Bone Marrow Transplant Program Philadelphia, Pennsylvania  19111
Medical College of Wisonsin Milwaukee, Wisconsin  53226