granulocyte colony-stimulating factor + placebo (Sanofi)

Granulocyte colony-stimulating factor (G-CSF) plus placebo refers to the control arm regimen used in a pivotal Phase 3 clinical trial (AMD3100-3102) sponsored by Genzyme (a Sanofi company). This regimen was compared against the combination of plerixafor (Mozobil) and G-CSF for the mobilization of hematopoietic stem cells in patients with multiple myeloma undergoing autologous stem cell transplantation. G-CSF, specifically filgrastim in this context, is a recombinant cytokine that stimulates the bone marrow to produce and release stem cells into the peripheral blood by binding to the G-CSF receptor (CSF3R). The placebo was administered as a subcutaneous injection to maintain the double-blind nature of the study. The trial results demonstrated that the addition of plerixafor significantly improved the success rate of stem cell collection compared to the G-CSF plus placebo control arm, leading to the regulatory approval of plerixafor.

Other names

G-CSF + placebofilgrastim + placebogranulocyte colony-stimulating factor + placebo-Genzyme, a Sanofi Company-multiple myeloma