Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00395967
Status:
TERMINATED
Last Update Posted:
2015-05-01
First Post:
2006-11-02
Brief Title:
AMD3100 Plerixafor in Multiple Myeloma MM or Non-Hodgkins Lymphoma NHL Patients Predicted to be Unable to Mobilize With G-CSF Alone
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Effect of AMD3100 240µgkg on the Apheresis Yield of CD34 Cells When Given To Multiple Myeloma or Non-Hodgkins Lymphoma Patients Predicted to be Unable to Mobilize 2 x 106 CD34 Cells in Three Apheresis Days When Given G-CSF Alone
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment terminated in 2005 to focus on Phase 3 study enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 plerixafor in patients with non-Hodgkins lymphoma NHL or multiple myeloma MM who were predicted to be unable to mobilize 2106 CD34 cellskg within 3 apheresis days Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy were to undergo autologous transplantation and met the inclusionexclusion criteria
The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor G-CSF can increase the circulating levels of peripheral blood stem cells PBSCs in patients whose peripheral CD34 counts remain low after treatment with G-CSF alone whether it was safe and whether transplantation with the apheresis product was successful as measured by time to engraftment of polymorphonuclear leukocytes PMNs and platelets PLTs
The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor G-CSF can increase the circulating levels of peripheral blood stem cells PBSCs in patients whose peripheral CD34 counts remain low after treatment with G-CSF alone whether it was safe and whether transplantation with the apheresis product was successful as measured by time to engraftment of polymorphonuclear leukocytes PMNs and platelets PLTs
Detailed Description:
A Phase 2 single-center open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkins lymphoma NHL or multiple myeloma MM who were predicted to be unable to mobilize 2106 CD34 cellskg within 3 apheresis days The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis
Following screening procedures eligible patients undergo mobilization with G-CSF 10 µgkg every day for 5 days and their peripheral blood PB CD34 cell count was measured on the fifth day
On Day 5 if the patients peripheral CD34 cell count was 5 cellsµl or 20 cellsµl the patient did not enter this study and was treated as per the policy of the study site
On Day 5 if the patients peripheral CD34 cell count was 5 to 7 cellsµl inclusive the patient did not undergo apheresis that day but did receive plerixafor 240 µgkg that evening and G-CSF followed by apheresis the next morning The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until 5106 cellskg are collected
On Day 5 if the patients peripheral CD34 cell count was 8 to 19 cellsµl inclusive then heshe underwent apheresis that day If this apheresis yield was 13106 CD34 cellskg then the patient was predicted to be unlikely to collect 2106 CD34 cellskg in 3 days of apheresis and received plerixafor 240 µgkg that evening However if the apheresis yield on Day 5 was 13106 CD34 cellskg then the patient did not enter the study
The next morning Day 6 eligible patients received G-CSF 10 µgkg and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose If the apheresis yield was at least double the apheresis yield on Day 5 then the patient received another 1000 pm dose of plerixafor and underwent apheresis again the next morning Day 7 after receiving G-CSF The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until 5106 cellskg were collected
All patients after the completion of apheresis procedures or after 5106 cellskg were collected received high-dose chemotherapy in preparation for transplantation Patients were transplanted with cells collected after receiving plerixafor with G-CSF However if there were insufficient cells cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone
Hematological activity of plerixafor was evaluated by assessing the number of CD34 cells harvested during apheresis
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
Following screening procedures eligible patients undergo mobilization with G-CSF 10 µgkg every day for 5 days and their peripheral blood PB CD34 cell count was measured on the fifth day
On Day 5 if the patients peripheral CD34 cell count was 5 cellsµl or 20 cellsµl the patient did not enter this study and was treated as per the policy of the study site
On Day 5 if the patients peripheral CD34 cell count was 5 to 7 cellsµl inclusive the patient did not undergo apheresis that day but did receive plerixafor 240 µgkg that evening and G-CSF followed by apheresis the next morning The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until 5106 cellskg are collected
On Day 5 if the patients peripheral CD34 cell count was 8 to 19 cellsµl inclusive then heshe underwent apheresis that day If this apheresis yield was 13106 CD34 cellskg then the patient was predicted to be unlikely to collect 2106 CD34 cellskg in 3 days of apheresis and received plerixafor 240 µgkg that evening However if the apheresis yield on Day 5 was 13106 CD34 cellskg then the patient did not enter the study
The next morning Day 6 eligible patients received G-CSF 10 µgkg and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose If the apheresis yield was at least double the apheresis yield on Day 5 then the patient received another 1000 pm dose of plerixafor and underwent apheresis again the next morning Day 7 after receiving G-CSF The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until 5106 cellskg were collected
All patients after the completion of apheresis procedures or after 5106 cellskg were collected received high-dose chemotherapy in preparation for transplantation Patients were transplanted with cells collected after receiving plerixafor with G-CSF However if there were insufficient cells cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone
Hematological activity of plerixafor was evaluated by assessing the number of CD34 cells harvested during apheresis
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