Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoetic Stem Cell Mobilization
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: lenograstim 10 microgram/kg/day
Type: Drug
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
Asan Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Start Date
July 2014
Completion Date
December 2015
Sponsors
Asan Medical Center
Source
Asan Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page