A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Orphan Biovitrum

Criteria

Inclusion Criteria:

• Multiple myeloma (MM) subjects scheduled to receive high-dose Melphalan in a one day schedule followed by autologous peripheral blood progenitor cell (PBSCT)

• Body Mass Index (BMI) ≤ 35

• 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

• Women in child bearing potential must have a negative pregnancy test

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

• Currently active oral mucositis infection

• Positive for HIV, hepatitis B or C

• Subject is unable or unwilling to follow with study procedures

• Subject is pregnant or is breast feeding

• Subject has not agreed to use adequate contraceptive precautions