This is a single-group treatment, phase IV, open label study to assess the mobilization efficacy and safety of plerixafor in combination with G- CSF in male and female participants from 18 to 75 years of age with multiple myeloma for autologous transplantation. Study Duration-Screening-up to 30-day. Intervention and CD34+cells apheresis up-to 8 day. A follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier. Study duration up to 75 days. For treatment phase visit frequency-daily.
The study duration consists of: An up-to 30-day screening, an up-to 8-day intervention and CD34+ cells apheresis and a follow up for 30 days (+7 days) post last dose of plerixafor, or the initiation of ablative chemotherapy, or the first dose of G-CSF administration in rescue procedure, whichever occurs earlier
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
subcutaneous (SC) injection
Investigational Sites
China, China
The proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 2 or fewer apheresis days
Time frame: Day 5 to Day 6
the proportion of patients collecting more than or equal to 6x106 CD34+ cells/kg in 4 or fewer apheresis days
Time frame: Day 5 to Day 8
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 2 or fewer apheresis days
Time frame: Day 5 to Day 6
the proportion of patients collecting more than or equal to 2x106 CD34+ cells/kg in 4 or fewer apheresis days
Time frame: Day 5 to Day 8
the number of apheresis days required to reach more than or equal to 6x106 CD34+ cells/kg
Time frame: Day 5 to Day 8
Peripheral Blood CD34+ count from Day 4 to Day 5 with the venous samples for Fluorescent activated cell sorting analysis obtained on the morning of Day 4 prior to administration of G-CSF and morning of Day 5 prior to administration of G-CSF
Time frame: Day 4 to Day 5
Number of participants with Adverse events and Serious adverse events
Time frame: Baseline to Day 30 (+7 days)
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