Multiple Myeloma
Conditions
Brief 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.
Interventions
DRUGlenograstim 10 microgram/kg/day
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pharmacokinetic data of lenograstim | on day 1 of apheresis | AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim |
Secondary
| Measure | Time frame |
|---|---|
| pharmacodynamic data: CD34+ cell count by flow cytometry | on day 1 of apheresis |
| pharmacodynamic data: absolute neutrophil count | on day 1 of apheresis |
| pharmacodynamic data: hematopoietic progenitor cells (HPC) | on day 1 of apheresis |
Countries
South Korea
Outcome results
None listed