多発性骨髄腫を有する日本人患者における末梢血造血幹細胞の動員および採取のためのプレリキサフォルと顆粒球コロニー刺激因子（G-CSF）の併用療法
基本情報
- NCT ID
- NCT02221479
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 14
- 治験依頼者名
- Sanofi
概要
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.