Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396383
Status:
TERMINATED
Last Update Posted:
2014-03-13
First Post:
2006-11-02
Brief Title:
Treatment With AMD3100 Plerixafor in MM Patients to Mobilize PBCs For Collection and for Transplantation
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
Status:
TERMINATED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient cell mobilization for tandem transplants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine whether 240 µgkg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma MM patients In addition this study determines if plerixafor alone can be used to mobilize peripheral blood progenitor cells PBPCs for transplantation in MM patients The minimum number of CD34 cells to collect is 2106 CD34 cellskg and the target is 4106 CD34 cellskg Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes PMN and platelet PLT engraftment Durability of transplant will be assessed for a minimum of one year
Detailed Description:
This study will examine whether 240 µgkg plerixafor given alone for up to 4 days is safe and well tolerated in multiple myeloma MM patients In addition this study determines if 240 µgkg plerixafor alone can be used to mobilize peripheral blood progenitor cells PBPCs for transplantation in MM patients The minimum number of CD34 cells to collect is 2106 CD34 cellskg and the target is 4106 CD34 cellskg Success of transplant engraftment will be measured by the number of days to polymorphonuclear leukocytes PMN and platelet PLT engraftment Durability of engraftment will be assessed for a minimum of one year
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