Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoetic Stem Cell Mobilization
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Name: lenograstim 10 microgram/kg/day
Type: Drug
Overall Status
Not yet recruiting
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
Asan Medical Center
Seoul, Korea, Republic of
Status: Not yet recruiting
Start Date
July 2014
Completion Date
December 2015
Asan Medical Center
Asan Medical Center
Record processing date processed this data on July 28, 2015 page