Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322842
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2006-05-04
Brief Title:
Treatment With AMD3100 Plerixafor in Non-Hodgkins Lymphoma and Multiple Myeloma Patients
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Treatment With AMD3100 in Non-Hodgkins Lymphoma and Multiple Myeloma Patients to Increase the Number of Peripheral Blood Stem Cells When Given a Mobilizing Regimen of G-CSF
Status:
COMPLETED
Status Verified Date:
2014-02
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:
This study evaluates the safety of plerixafor and other outcomes that are purely exploratory in nature One other pre-specified outcome is to evaluate an interval of 10-11 hours between dosing with plerixafor and the beginning of apheresis to determine if there will be at least a 2-fold increase in circulating CD34 cells Data from this protocol will assist in the determination of the dosing schedule for future studies
Detailed Description:
Participants with non-Hodgkins lymphoma and multiple myeloma who have undergone prior cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a combination of plerixafor and granulocyte colony-stimulating factor G-CSF mobilization regimen on the day prior to apheresis The only change to standard of European care is the addition of plerixafor to a G-CSF mobilizing regimen Participants will undergo mobilization with G-CSF 10 µgkg each day and on each day prior to apheresis will receive plerixafor 240 µgkg Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of 5106 CD34 stem cellskg Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen The number of CD34 cells mobilized in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and those harvested in the apheresis product will be measured The number of apheresis sessions required to obtain 5106 CD34 cellskg will also be measured Success of the transplantations will be evaluated by the time to engraftment of poly-morphonuclear leukocytes PMN and platelets PLT Participants will be followed for durability of their transplant for 12 months following transplantation
This study was previously posted by AnorMED Inc In November 2006 AnorMED Inc was acquired by Genzyme Corporation Genzyme Corporation is the sponsor of the trial
This study was previously posted by AnorMED Inc In November 2006 AnorMED Inc was acquired by Genzyme Corporation Genzyme Corporation is the sponsor of the trial
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