Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization

Asan Medical Center

Status: Unknown

Conditions: Multiple Myeloma

Treatments: Drug: lenograstim 10 microgram/kg/day

Study type: Interventional

Funder types: Other

Identifiers

NCT02184897

AMC_MM01

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

AM group

Active Comparator group

Description:

Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.

Treatment:

Drug: lenograstim 10 microgram/kg/day

PM group

Experimental group

Description:

Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5

Treatment:

Drug: lenograstim 10 microgram/kg/day