Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

Not Applicable

• Conditions: Multiple Myeloma
• Interventions: Drug: lenograstim 10 microgram/kg/day

• Registration Number: NCT02184897
• Lead Sponsor: Asan Medical Center

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

Not available

Study Timeline

• Study First Submitted: 2014-06-22
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-06
• Study First Posted: 2014-07-09
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-23
• Last Update Posted: 2016-07-26
• Primary Completion: 2016-08
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AM group	lenograstim 10 microgram/kg/day	Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
PM group	lenograstim 10 microgram/kg/day	Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5

Primary Outcome Measures

Name	Time	Method
pharmacokinetic data of lenograstim	on day 1 of apheresis	AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim

Secondary Outcome Measures

Name	Time	Method
pharmacodynamic data: absolute neutrophil count	on day 1 of apheresis
pharmacodynamic data: hematopoietic progenitor cells (HPC)	on day 1 of apheresis
pharmacodynamic data: CD34+ cell count by flow cytometry	on day 1 of apheresis

Trial Locations

Locations (2)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of