Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

Phase 3 Completed 302 enrolled Genzyme, a Sanofi Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

Timeline

Start: 2005-01
Primary completion: 2006-10
Completion: 2008-01

Outcome

Met primary endpoint

paper 106 of 148 (71.6%) patients in the plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint PMID 19363221 ↗

paper plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint (P < .001). PMID 19363221 ↗

Publications

Results DiPersio JF, Stadtmauer EA, Nademanee A, Micallef IN, Stiff PJ, Kaufman JL, Maziarz RT, Hosing C, Fruehauf S, Horwitz M, Cooper D, Bridger G, Calandra G; 3102 Investigators. Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma. Blood. 2009 Jun 4;113(23):5720-6. doi: 10.1182/blood-2008-08-174946. Epub 2009 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plerixafor	Small molecule	240 ug/kg	Subcutaneous
Background	filgrastim	Protein / enzyme biologic	10 ug/kg	Subcutaneous