drugset / Trial / NCT00322491

Mobilization of Stem Cells With AMD3100 (Plerixafor) and G-CSF in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients

NCT00322491

Phase 2 Completed 49 enrolled Genzyme, a Sanofi Company AnorMED · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.

Timeline

Start
2004-03
Primary completion
2006-06
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule 240 ug/kg Subcutaneous
Background Granulocyte colony-stimulating factor Protein / enzyme biologic 10 ug/kg Subcutaneous