Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

July 23, 2016 updated by: Cheolwon Suh, Asan Medical Center

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, University of Ulsan College of Medicine
      • Seoul, Korea, Republic of, 1387-736
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AM group
Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
Drug: lenograstim 10 microgram/kg/day
Experimental: PM group
Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5
Drug: lenograstim 10 microgram/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacokinetic data of lenograstim
Time Frame: on day 1 of apheresis
AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim
on day 1 of apheresis

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

June 22, 2014

First Submitted That Met QC Criteria

July 6, 2014

First Posted (Estimate)

July 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 23, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC_MM01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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