Expanded Acess Study of Plerixafor and G-CSF for the Mobilization and Collection of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease or Multiple Myeloma
The Expanded Access Program (EAP)(protocol number MOZ00607) is an open label study intended
to provide access to plerixafor for patients with non-Hodgkin's Lymphoma, Hodgkin's Disease,
or Multiple Myeloma who are to receive treatment with an autologous hematopoietic stem cell
transplant. Patients who have previously failed stem cell mobilization attempts or who have
previously received an autologous or allogeneic stem cell transplant are not eligible to
enroll in this program. The standard of care regimen for stem cell mobilization includes a
growth factor, G-CSF, to increase peripheral blood stem cells. Plerixafor is given on the
evening prior to doses of standard treatment with G-CSF. The combination of G-CSF and
plerixafor has the potential to increase the number of circulating stem cells. The stem
cells develop into specialized white blood cells and platelets that are necessary for immune
system function and normal blood clotting. The stem cells are removed by a process called
apheresis, in which blood is drawn from the patient, the stem cells are separated from the
plasma, and the plasma is returned to the patient. The separated stem cells are frozen,
similar to the blood banking process. The patient then receives chemotherapy according to
the institutional standard. After chemotherapy, stem cell transplant is intended to
replenish cells in the bone marrow that may be destroyed by chemotherapy.
Expanded Access
N/A
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
MOZ00607
NCT00720603
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