Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

NCT ID: NCT02184897

Last Updated: 2016-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AM group

Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.

Group Type ACTIVE_COMPARATOR

lenograstim 10 microgram/kg/day

Intervention Type DRUG

PM group

Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5

Group Type EXPERIMENTAL

lenograstim 10 microgram/kg/day

Intervention Type DRUG

Interventions

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lenograstim 10 microgram/kg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cheolwon Suh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AMC_MM01

Identifier Type: -

Identifier Source: org_study_id

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