Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Lenograstim

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