A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00434161

Purpose

The purpose of this study is to evaluate the efficacy and effect of palifermin on the incidence of oral mucositis in subjects with multiple myeloma receiving Melphalan followed by autologous peripheral blood stem cell transplantation. Amendment 01 (April 07) introduced three cataract assessments to be carried out at Screening, Month 6 and Month 12 in response to FDA and EMEA follow up measures.

Condition	Intervention	Phase
Multiple Myeloma	Drug: palifermin Drug: placebo	Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Cataract Multiple Myeloma

Drug Information available for: Melphalan Melphalan hydrochloride Sarcolysin Palifermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Study of Two Different Schedules of Palifermin for Reduction in Severity of Oral Mucositis in Subjects With Multiple Myeloma (MM) Receiving High Dose Melphalan Followed by Autologous Peripheral Blood Stem Cell Transplantation (PBSCT)

Further study details as provided by Amgen:

Primary Outcome Measures:

Maximum severity of oral mucositis (WHO grades 0/1, 2, 3, or 4) [ Time Frame: at Day 32 ] [ Designated as safety issue: No ]
Incidence of cataract development or progression (change of ≥0.3 in LOCS III score) [ Time Frame: at month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence and duration of ulcerative mucositis (WHO grades 2, 3, and 4) [ Time Frame: at Day 32 ] [ Designated as safety issue: No ]
Incidence and duration of severe oral mucositis (WHO grades 3, and 4) [ Time Frame: at Day 32 ] [ Designated as safety issue: No ]
Patient-reported mouth and throat soreness score (area under the curve) [ Time Frame: at Day 32 ] [ Designated as safety issue: No ]
Incidence of cataract development or progression (change of ≥0.3 in LOCS III score) [ Time Frame: at Month 6 ] [ Designated as safety issue: No ]
Incidence of an increase from baseline in cataract progression (increase of ≥0.3 in LOCS III score) [ Time Frame: at months 6 and 12 ] [ Designated as safety issue: No ]
Change from baseline in cataract progression (based on LOCS III score) [ Time Frame: at months 6 and 12 ] [ Designated as safety issue: No ]
Incidence of a decreased from baseline in best corrected visual acuity (BCVA) as measured by a change of 10 letters on the ETDRS (Early Termination Diabetic Retinopathy Study) at 4 meters [ Time Frame: at months 6 and 12 ] [ Designated as safety issue: No ]
Incidence of all adverse events and laboratory abnormalities [ Time Frame: at Day 32 ] [ Designated as safety issue: Yes ]
Overall Survival [ Time Frame: during long-term follow up phase (maximum of 10 years) ] [ Designated as safety issue: Yes ]
Progression Free Survival [ Time Frame: during long-term follow up phase (maximum of 10 years) ] [ Designated as safety issue: Yes ]
Time to disease progression [ Time Frame: during long-term follow up phase (maximum of 10 years) ] [ Designated as safety issue: Yes ]
Incidence of second primary malignancies or other malignancies [ Time Frame: during long-term follow up phase (maximum of 10 years) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	275
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Palifermin Pre Only: Experimental 110 subjects to receive palifermin pre-high dose chemotherapy (total 3 doses)	Drug: palifermin one bolus IV injection at 60 μg/kg/day, on Days -6, -5 & -4 (pre-high dose chemotherapy) and on Days 0, 1 & 2 (post-high dose chemotherapy). Minimum of 4 days between pre-chemotherapy and post-transplantation dosing.
Placebo: Placebo Comparator 55 subjects to receive matched placebo pre- and post-high dose chemotherapy	Drug: placebo one bolus IV injection at 60 μg/kg/day of matched placebo
Palifermin Pre and Post: Experimental 110 subjects to receive palifermin pre- and post-high dose chemotherapy (total of 6 doses)	Drug: palifermin one bolus IV injection at 60 μg/kg/day, on Days -6, -5 & -4 (pre-high dose chemotherapy) and on Days 0, 1 & 2 (post-high dose chemotherapy). Minimum of 4 days between pre-chemotherapy and post-transplantation dosing.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan in a one day schedule followed by autologous PBSCT
BMI ≤ 25
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, or an ECOG status of 3 if the reason for a status of 3 is exclusively due to MM (e.g. pathological fracture)
Functional hematopoietic, hepato-renal and pulmonary systems
Subjects at minimum with a baseline best corrected visual acuity (BCVA) of 20/40, (6/12 or 0.5 on the decimal scale) or better using the ETDRS chart in one eye
Subject at minimum with one eye with a natural, intact lens
Subject who has a LOCS III score at baseline of P < 1.0, C < 2.0 and NO < 2.0 in at least one eye

Exclusion Criteria:

Presence or history of any other malignancy (other than curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy, without evidence of disease for > 3 years
Prior autologous or allogeneic transplants
Prior treatment with palifermin, or other fibroblast or keratinocyte growth factors
Receiving dialysis
History of cataract surgery in both eyes
Incapable of being responsive to midriatic agents
History of other ocular disease (e.g., macular degeneration, glaucoma, corneal disease) that would make assessment of visual status difficult
Subject is scheduled to undergo cataract surgery
Subject with any disease, that in the opinion of the ophthalmologist, could adversely effect the subject's vision during the course of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434161

Contacts

Contact: Amgen Call Center

866-572-6436

Show 44 Study Locations

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050219
Study First Received:	February 8, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00434161
Health Authority:	Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information; Belgium: Service Public Federal Sante Publiquest, Securite de la Chaine alimentaire et Environnement; Czech Republic: Statni ustav pro kontrolu leciv; Denmark: Laegemiddelstyrelsen; Finland: Lääkelaitos; France: Afssaps - French Health Products Safety Agency; Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe; Hungary: National Institute of Pharmacy; Ireland: Irish Medicines Board; Italy: Ministry of Health; Netherlands: Medisch Centrum Rijnmond_Zuid, lcatie Zuider; Sweden: Medical Products Agency; Switzerland: Agency for Therapeutic Products; United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amgen:

Palifermin
KGF
Amgen
Clinical Trial

Oncology
Oral Mucositis
Multiple Myeloma
Cataract

Study placed in the following topic categories:

Mouth Diseases
Melphalan
Immunoproliferative Disorders
Mucositis
Stomatitis
Gastrointestinal Diseases
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Multiple Myeloma
Digestive System Diseases
Hemorrhagic Disorders
Multiple myeloma
Cataract
Stomatognathic Diseases
Gastroenteritis
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009