Ignite Creation Date:
2024-05-06 @ 3:02 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02184897
Status:
UNKNOWN
Last Update Posted:
2016-07-26
First Post:
2014-06-22
Brief Title:
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Twenty four patients with multiple myeloma will be randomized to either AM group administration of lenograstim at 8 am or PM group administration of lenograstim at 6 am Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group respectively Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34 cell count absolute neutrophil cell count and hematopoeitic progenitor cell count In addition the yield of stem cell collection between two arms will be analyzed
Detailed Description:
None
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