Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306735
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2006-03-22
Brief Title:
Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
A Double-blind Phase 2 Study to Assess the Safety and Efficacy of Aloxi Palonosetron HCl for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving High-dose Melphalan as Conditioning Chemotherapy for Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2015-11
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 primary purpose of this study is to explore the efficacy of three different dose schedules of palonosetron for the prevention of emesis over a 7-day study interval in multiple myeloma patients
Detailed Description:
A number of multiple-day chemotherapy regimens involving moderately or highly emetogenic agents are used for the treatment of cancers Further patients undergoing high-dose conditioning regimens in combination with bone marrow or stem cell transplants remain poorly controlled in terms of CINV Patients treated with these regimens are at risk for developing CINV with each treatment as well as in the delayed setting
Palonosetron to date has been studied against single-day moderately and highly emetogenic chemotherapy regimens It is of interest therefore to explore the safety and efficacy of palonosetron when administered during a multiple-day chemotherapy regimen For this purpose a population receiving melphalan 100 mgm2 as a conditioning regimen before stem cell transplant for the treatment of multiple myeloma was selected
Palonosetron to date has been studied against single-day moderately and highly emetogenic chemotherapy regimens It is of interest therefore to explore the safety and efficacy of palonosetron when administered during a multiple-day chemotherapy regimen For this purpose a population receiving melphalan 100 mgm2 as a conditioning regimen before stem cell transplant for the treatment of multiple myeloma was selected
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