The primary objective of this study is to evaluate tumor cell mobilization (TCM) with non-pegylated G-CSF alone compared with non-pegylated G-CSF plus plerixafor in patients with multiple myeloma (MM) who are potentially poor mobilizers of hematopoietic stem cells (HSC). Second objectives are to evaluate survival and disease status of G-CSF alone compared with GCSF plus plerixafor, and the efficacy and safety of G-CSF plus plerixafor when used to mobilize stem cells for autologous transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
240mcg/kg, solution, subcutaneous injection
10 mcg/kg, solution, subcutaneous injection
Investigational Site Number 056002
Bruges, Belgium
Investigational Site Number 233001
Tallinn, Estonia
Investigational Site Number 440001
Vilnius, Lithuania
Investigational Site Number 752001
Stockholm, Sweden
Investigational Site Number 752002
Umeå, Sweden
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/CD34+ cells
Peripheral blood parameters
Time frame: Day 1 to Day 8 of the apheresis/treatment period
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/plerixafor cumulative dose/kg body weights
Peripheral blood parameters
Time frame: Day 5 to Day 8 of the apheresis/treatment period
The presence of myeloma tumor cells as measured by the percentage of myeloma tumor cells/G-CSF cumulative dose/kg body weight
Peripheral blood parameters
Time frame: Day 5 to Day 8 of the apheresis/treatment period
The change in tumor cell mobilization(TCM) in the peripheral blood
Peripheral blood parameters
Time frame: Day 4 pre-G-CSF to Day 5 pre-G-CSF
The number of myeloma tumor cells per patient at each apheresis
Apheresis product parameters
Time frame: Day 1 to Day 8 of the apheresis/treatment period
The number of patients who mobilize at least 4.5x10^5 myeloma tumor cells/kg body weight as measured in each apheresis product
Apheresis product parameters
Time frame: Day 5 to Day 8 of the apheresis/treatment period
CD34+ stem cell yield in the apheresis product
Time frame: Day 1 to Day 8 of the apheresis/treatment period
The number of patients that proceed to transplantation
Time frame: Up to 2 months after final apheresis
Overall survival
Time frame: Day 100 post transplant and up to 2 years post first-G-CSF dose
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