A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00323518

Enrollment

390

Registered

2006-05-09

Start date

2006-05-31

Completion date

2008-08-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Mucositis, Stomatitis

Keywords

oral mucositis, hematologic, autologous stem cell transplant, velafermin, stomatitis, oncology - supportive care, mouth diseases

Brief summary

CG53135-05 (velafermin), a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to confirm the safety and efficacy of CG53135-05 (velafermin) when administered as a single dose to patients at risk for developing oral mucositis.

Interventions

DRUGvelafermin

administered intravenously as 100mL single dose over 15 minutes on day 1

DRUGplacebo

administered intravenously as 100mL single dose over 15 minutes on day 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 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

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

Design outcomes

Primary

Measure	Time frame
the incidence of grade 3/4 oral mucositis using WHO grading system	evaluated throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026