A Double-Blind, Randomized, Placebo-controlled Study of Two Different Schedules of Palifermin (Pre- and Post Chemotherapy and Pre-Chemotherapy only) 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)

Conditions: Oral Mucositis Induced by High Dose ChemotherapyCataract development associated with palifermin administration
MedDRA version: 8.1Level: LLTClassification code 10028130Term: Mucositis oral
MedDRA version: 9.1Level: LLTClassification code 10007739Term: Cataract

Registration Number: EUCTR2006-003709-15-DE

Lead Sponsor: Biovitrum AB (publ)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 275

Inclusion Criteria

• Multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan (200 mg/m2 if creatinine clearance = 30 mL/min or 140 mg/m2 if creatinine clearance < 30 mL/min), in a one day schedule (day -2) followed by autologous PBSCT (day 0)
• Age = 18 years and = 70 years
• BMI = 35
• ECOG performance status = 2, or an ECOG status of 3 if the reason for a status of 3 is due exclusively due to MM (e.g. pathological fracture)
• Adequate pulmonary function as measured by a corrected carbon monoxide (CO) diffusing capacity (DLCO) = 50% of predicted
• Minimum of 2.0 x 106 CD34+ cells/kg collected for autologous transplantation
• Adequate hematological function (ANC = 1.5 x 109/L and platelet count = 100 x 109/L)
• Total bilirubin = 2 mg/dL
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 4.0 x IULN
• Negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment
• Each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication

Cataract specific:
All subjects eligible for 20050219 will also be assessed for their eligibility for cataract
assessment procedures. If a subject is not eligible for cataract assessment procedures, or the site has a waiver from Amgen regarding cataract assessments, the subject may still be eligible for inclusion in the study but will be exempt from the cataract assessments.
• 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• History of or concurrent malignancy other than MM, with the exception of 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 treatment with palifermin, or other fibroblast or keratinocyte growth factors
(eg, KGF-2)
• Prior autologous or allogeneic transplants
• Currently active infection of oral mucositis
• Oral abnormalities defined as baseline oral assessment of WHO grade > 0
• Receiving dialysis
• Twenty-eight days or less between receiving any other investigational drug or device and randomization into this study
• Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
• Subject has not agreed to using adequate contraceptive precautions
• Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B virus (HBSAg+), or hepatitis C virus (HCV)
• Subject has known sensitivity to any of the products to be administered during dosing, including E coli-derived products
• Subject has previously been treated on this study
• Unwilling or unable to complete the patient-reported outcome questionnaires
• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures

Cataract specific:
• History of cataract surgery in both eyes
• Incapable of being responsive to midriatic agents (minimum of approximately a 6
mm pupil required)
• History of other ocular disease leading to visual loss (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