Multiple Myeloma Clinical Trial
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 Receiving Melphalan Followed by Autologous Blood Stem Cell Transplantation
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.
This was a double-blind, placebo-controlled, randomized, multicenter Phase IIIb study of
palifermin given before and after dose chemotherapy (total 6 doses) or before dose
chemotherapy only (total 3 doses), in subjects with Multiple Myeloma (MM)receiving high dose
melphalan (chemotherapy), in a 1-day schedule, followed by autologous Peripheral Blood Stem
Cell Transplantation (PBSCT).
All subjects were to be followed for disease progression, second primary tumors, additional
malignancies and survival for up to 10 years.
Planned: 275 subjects, in fact, 281 subjects were randomized. Randomized: 115 subjects to
palifermin pre/post-CT, 109 subjects to palifermin pre-CT and 57 subjects to placebo
Analyzed: 281 subjects in the full analysis set, 277 subjects in the safety subset.
Efficacy Oral cavity assessment, patient reported outcome (PRO) questionnaires (Oral
Mucositis Daily Questionnaire [OMDQ], Functional Assessment of Cancer Therapy Esophageal
[FACT-E], European Quality of Life Utility Scale [EQ 5D], Mucositis Chronic Symptoms
Questionnaire [MCSQ]).
Safety Physical examination (including body temperature), concomitant medications,
transfusions, vital signs, laboratory assessments (hematology, chemistry), cataract
assessments, adverse events (AEs).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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