Plerixafor Plus Granulocyte Colony-stimulating Factor (G-CSF) For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Multiple Myeloma
- Registration Number
- NCT02221479
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
Primary Objective:
To determine if Multi Myeloma (MM) patients mobilized with granulocyte colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a target number of greater than or equal to 6 x 10\^6 cluster of differentiation (CD) 34+ cells/kg in 2 or fewer days of apheresis than MM patients mobilized with G-CSF alone.
Secondary Objectives:
* To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in MM patients.
* To compare the 2 treatment arms with respect to the number of participants who achieved a minimum of 2 x 10\^6 CD34+ cells/kg in 4 or fewer days of apheresis.
* To compare the 2 treatment arms with respect to the number of days of apheresis required to reach the target of greater than or equal to 6 x 10\^6 CD34+ cells/kg.
- Detailed Description
Total study duration for a participant can be approximately up to 68 days.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description G-CSF plus plerixafor plerixafor GZ316455 G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7) G-CSF plus plerixafor Filgrastim G-CSF administered up to 8 days (Day 1 to Day 8) and plerixafor administered for 4 days (Day 4 to Day 7) Granulocyte colony-stimulating factor (G-CSF) alone Filgrastim G-CSF administered up to 8 days
- Primary Outcome Measures
Name Time Method Proportion of participants who achieve a collection of greater than or equal to 6 x10^6 cells/kg CD34+ cells in less than or equal to 2 days of apheresis Day 5 to Day 8 of the apheresis/treatment period
- Secondary Outcome Measures
Name Time Method Proportion of participants who achieve a collection of a minimum target of 2 x10^6 cells/kg CD34+ cells in less than or equal to 4 days of apheresis Day 5 to Day 8 of the apheresis/treatment period Number of days of apheresis to collect 6 x10^6 cells/kg CD34+ cells Day 5 to Day 8 of the apheresis/treatment period Number of days of apheresis to collect 2 x10^6 cells/kg CD34+ cells Day 5 to Day 8 of the apheresis/treatment period Total number of CD34+ cells/kg collected over up to 4 apheresis Day 5 to Day 8 of the apheresis/treatment period The relative increase (ratio) of peripheral blood CD34+ cell count (cells/μL) From Day 4 morning to Day 5 morning for both arms, from Day 4 morning to Day 4 evening for GP arm only, and from Day 4 evening to Day 5 morning for GP arm only Number of participants with adverse events Up to 68 days Change from baseline in clinical laboratory measurements Up to 68 days
Trial Locations
- Locations (5)
Investigational Site Number 392105
🇯🇵Kamogawa-Shi, Japan
Investigational Site Number 392103
🇯🇵Kyoto-Shi, Japan
Investigational Site Number 392104
🇯🇵Okayama-Shi, Japan
Investigational Site Number 392101
🇯🇵Shibuya-Ku, Japan
Investigational Site Number 392102
🇯🇵Nagoya-Shi, Japan