Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Mucositis | — | UNRESOLVED | — |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| velafermin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- 1
- description
- placebo
- interventionNames
- Drug: placebo
- type
- EXPERIMENTAL
- label
- 2
- description
- 30 mcg/kg velafermin
- interventionNames
- Drug: velafermin
- type
- EXPERIMENTAL
- label
- 3
- description
- 10 mcg/kg velafermin
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available