Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434161
Status:
COMPLETED
Last Update Posted:
2015-03-30
First Post:
2007-02-08
Brief Title:
A Study of Palifermin for the Reduction of Oral Mucositis in Subjects With Multiple Myeloma
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 MMreceiving 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 prepost-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
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 prepost-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None