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Clinical Trial 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.


Clinical Trial Description

Total study duration for a participant can be approximately up to 68 days. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02221479
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date October 2014
Completion date July 2015

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