Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
1 other identifier
interventional
24
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable multiple-myeloma
Started Jul 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 26, 2016
July 1, 2016
2.1 years
June 22, 2014
July 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
pharmacokinetic data of lenograstim
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
on day 1 of apheresis
Secondary Outcomes (3)
pharmacodynamic data: CD34+ cell count by flow cytometry
on day 1 of apheresis
pharmacodynamic data: absolute neutrophil count
on day 1 of apheresis
pharmacodynamic data: hematopoietic progenitor cells (HPC)
on day 1 of apheresis
Study Arms (2)
AM group
ACTIVE COMPARATORLenograstim is administered at 8 am and apheresis is started at 10 am on D4.
PM group
EXPERIMENTALLenograstim is administered at 6 pm and apheresis is started at 8 am on D5
Interventions
Eligibility Criteria
You may qualify if:
- age: above 17 years, below 65 years old
- informed consent
- ECOG 0-1
- autologous stem cell transplant candidate among patients with multiple myeloma
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Asan Medical Center, University of Ulsan College of Medicine
Seoul, 138-736, South Korea
Asan Medical Center
Seoul, 1387-736, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 22, 2014
First Posted
July 9, 2014
Study Start
July 1, 2014
Primary Completion
August 1, 2016
Study Completion
December 1, 2016
Last Updated
July 26, 2016
Record last verified: 2016-07