Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322491
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2006-05-04
Brief Title:
Mobilization of Stem Cells With AMD3100 Plerixafor and G-CSF 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 and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor G-CSF for collection of peripheral blood stem cells PBSCs for autologous transplantation in patients with non-Hodgkins lymphoma NHL and multiple myeloma MM Efficacy outcomes include evaluation of fold increase in circulating CD34 cells from just before the first plerixafor injection to 10-11 hours post plerixafor just before apheresis and assessment of successful polymorphonuclear leukocyte PMN engraftment after transplantation Data from this protocol will assist in the determination of the dosing schedule for future studies
Detailed Description:
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy are to be autologously transplanted and meet the inclusionexclusion criteria are eligible to enter the study The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor G-CSF mobilization regimen on the day prior to apheresis Participants will undergo mobilization with G-CSF 10 mcgkg each day and will receive plerixafor 240 mcgkg in the evening prior to apheresis Participants will undergo apheresis for up to 5 consecutive days in order to collect the target number of CD34 stem cells 5106 CD34 cellskg for either single or tandem transplant After apheresis all participants will be treated with high-dose chemotherapy in preparation for transplantation Participants will be transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen The increase in CD34 cells in the peripheral blood from the time of the plerixafor dose to just prior to apheresis and the number of CD34 cells in the apheresis product will be measured The number of apheresis sessions required to obtain 5106 CD34 cells will also be measured Success of the transplantations will be evaluated by the time to engraftment of polymorphonuclear 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