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Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

NCT02184897 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-07-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

lenograstim 10 microgram/kg/day

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02184897 on ClinicalTrials.gov