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)
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 mydriatic 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