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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AM group | Active Comparator | Lenograstim is administered at 8 am and apheresis is started at 10 am on D4. |
|
| PM group | Experimental | Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenograstim 10 microgram/kg/day | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetic data of lenograstim | AUC0-24hr, Cmax, Cmin, Tmax, T1/2 of lenograstim | on day 1 of apheresis |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center, University of Ulsan College of Medicine | Seoul | 138-736 | South Korea | |||
| Asan Medical Center |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| on day 1 of apheresis |
| Seoul |
| 1387-736 |
| South Korea |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |