Back to resultsPharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
lenograstim 10 microgram/kg/day
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Myeloma
Eligibility Criteria
Inclusion Criteria:
- age: above 17 years, below 65 years old
- informed consent
- ECOG 0-1
- autologous stem cell transplant candidate among patients with multiple myeloma
Exclusion Criteria:
- prior history of hematopoetic stem cell transplantation
- history of failure to mobilize hematopoietic stem cells
- history of G-CSF administration within 2 weeks before enrollment to this study
Sites / Locations
- Asan Medical Center, University of Ulsan College of Medicine
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
AM group
PM group
Arm Description
Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5
Outcomes
Primary Outcome Measures
pharmacokinetic data of lenograstim
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
Secondary Outcome Measures
pharmacodynamic data: CD34+ cell count by flow cytometry
pharmacodynamic data: absolute neutrophil count
pharmacodynamic data: hematopoietic progenitor cells (HPC)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184897
Brief Title
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
Official Title
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AM group
Arm Type
Active Comparator
Arm Description
Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
Arm Title
PM group
Arm Type
Experimental
Arm Description
Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5
Intervention Type
Drug
Intervention Name(s)
lenograstim 10 microgram/kg/day
Primary Outcome Measure Information:
Title
pharmacokinetic data of lenograstim
Description
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
Time Frame
on day 1 of apheresis
Secondary Outcome Measure Information:
Title
pharmacodynamic data: CD34+ cell count by flow cytometry
Time Frame
on day 1 of apheresis
Title
pharmacodynamic data: absolute neutrophil count
Time Frame
on day 1 of apheresis
Title
pharmacodynamic data: hematopoietic progenitor cells (HPC)
Time Frame
on day 1 of apheresis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age: above 17 years, below 65 years old
informed consent
ECOG 0-1
autologous stem cell transplant candidate among patients with multiple myeloma
Exclusion Criteria:
prior history of hematopoetic stem cell transplantation
history of failure to mobilize hematopoietic stem cells
history of G-CSF administration within 2 weeks before enrollment to this study
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
1387-736
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
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