Oral Mucositis Induced by High Dose Chemotherapy Cataract development associated with palifermin administration MedDRA version: 13.1 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1 Level: PT Classification code 10007739 Term: Cataract System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Kepivance
Product Name: palifermin
Pharmaceutical Form:
INN or Proposed INN: Palifermin
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type: equal
Concentration number: 60-
Sponsors
Swedish Orphan Biovitrum AB (publ)
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of palifermin relative to placebo when given either pre- and post-high dose chemotherapy or pre- high dose chemotherapy only with regard to the severity of oral mucositis (WHO grades 0/ 1, 2, 3 or 4) Primary Cataract Evaluation Objectives: To assess cataract development or progression at month 12 based on an increase of = 0.3 in the Lens Opacities Classification System III (LOCS III) score for either posterior subcapsular cataract (P), cortical cataract (C), or nuclear opalescence (NO) (Chylack LT et al 1993). ;Secondary Objective: To assess the effect of palifermin on the incidence and duration of ulcerative oral mucositis (WHO grades 2, 3 and 4) and of severe mucositis (WHO grades 3 and 4) To evaluate the impact of palifermin on patient-reported mouth and throat soreness (MTS) Cataract Eval Objectives - To assess: -effect of palifermin on the change of posterior subcapsular cataract (P) using the Lens Opacities Classification System III (LOCS III) score. -effect of palifermin on the change of cortical cataract (C) using the Lens Opacities Classification System III (LOCS III) score. -effect of palifermin on the change of nuclear opalescence (NO) using the Lens opacities Classification System III (LOCS III) score. -effect of palifermin on the incidence of decreased best corrected visual acuity (BCVA) from the baseline BCVA on the ETDRS (“Early Treatment Diabetic Retinopathy Study”) chart, (Ferris III FL et al 1982, Ferris III FL et al 1993, Ferris III FL et al, 1996, Ferris III FL, Sperduto RD 1982).;Primary end point(s): Maximum severity of oral mucositis (WHO grades 0/1, 2, 3 or 4) Cataract specific endpoints: Incidence of cataract development or progression at month 12, based on an increase from baseline of = 0.3 in the LOCS III score for any of posterior subcapsular cataract (P), cortical cataract (C), or nuclear opalescence (NO). | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Hungary, Ireland, Italy, Netherlands, Sweden, United Kingdom
Outcome results
None listed