A Phase II Controlled Trial of Velafermin for Prevention of Oral Mucositis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00323518 |
Recruitment Status :
Completed
First Posted : May 9, 2006
Last Update Posted : April 13, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Oral Mucositis Stomatitis | Drug: velafermin Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | May 2006 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 1
placebo
|
Drug: placebo
administered intravenously as 100mL single dose over 15 minutes on day 1 |
Experimental: 2
30 mcg/kg velafermin
|
Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05 |
Experimental: 3
10 mcg/kg velafermin
|
Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05 |
Experimental: 4
60 mcg/kg velafermin
|
Drug: velafermin
administered intravenously as 100mL single dose over 15 minutes on day 1
Other Name: CG53135-05 |
- the incidence of grade 3/4 oral mucositis using WHO grading system [ Time Frame: evaluated throughout the study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00323518

Responsible Party: | CuraGen Corporation |
ClinicalTrials.gov Identifier: | NCT00323518 |
Other Study ID Numbers: |
CG53135-CLN-12 |
First Posted: | May 9, 2006 Key Record Dates |
Last Update Posted: | April 13, 2016 |
Last Verified: | March 2016 |
oral mucositis hematologic autologous stem cell transplant velafermin |
stomatitis oncology - supportive care mouth diseases |
Mucositis Stomatitis Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Mouth Diseases Stomatognathic Diseases |