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NCT02184897 Clinical Trial

Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

Multiple Myeloma Clinical Trial

Official title:
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02184897
Other study ID # AMC_MM01
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 22, 2014
Last updated July 23, 2016
Start date July 2014
Est. completion date December 2016

Study information
Verified date July 2016
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 24
Est. completion date December 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Drug:
• lenograstim 10 microgram/kg/day

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Asan Medical Center, University of Ulsan College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharmacokinetic data of lenograstim AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim on day 1 of apheresis No
Secondary pharmacodynamic data: CD34+ cell count by flow cytometry on day 1 of apheresis No
Secondary pharmacodynamic data: absolute neutrophil count on day 1 of apheresis No
Secondary pharmacodynamic data: hematopoietic progenitor cells (HPC) on day 1 of apheresis No
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