Plerixafor and G−CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non−Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) − Safety Study in a General Autologous Transplant Population
Patients with advanced or treatment-refractory Multiple Myeloma (MM), Hodgkin's Disease (HD)
and Non-Hodgkin's Lymphoma (NHL) may be successfully treated with high dose chemotherapy
followed by autologous transplantation of peripheral blood stem cells (PBSCs). Successful
engraftment of peripheral blood stem cells (PBSCs) is well correlated with the number of
CD34+ cells infused.
Stem cell collection with plerixafor could have a major benefit by increasing the
circulating number of PBSCs and decreasing the number of apheresis sessions required to
collect a sufficient number of PBSCs for transplant.
This is a multi-centre, open label, single-arm study intended to further investigate the
safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have
previously failed stem cell mobilisation attempts or who have previously received more than
one autologous or any allogeneic stem cell transplant are not eligible.
Screening for eligibility will take place up to 30 days before the first dose of G-CSF.
Patients will receive a stem cell mobilisation regimen consisting of plerixafor and G-CSF.
Patients will be given G-CSF for 4 consecutive days in the morning. Starting on the evening
of Day 4, plerixafor will be administered subcutaneously (SC). The plerixafor dose will be
timed to allow for a 10- to 11-hour interval between the plerixafor dosing and the
initiation of apheresis. Patients may continue to receive the evening dose of plerixafor
then G-CSF the next morning followed by apheresis for up to a total of 5 apheresis
procedures until a minimum of at least 5 x 106 CD34+ cells/kg for NHL/HD or 6 x 106 CD34+
cells/kg for MM are collected. More cells may be collected if done within the 5 apheresis
procedures. Stem cell collection will take place using standard procedures.
Following the last apheresis, patients will undergo pre-transplant myeloablative
chemotherapy followed by transplantation of the collected autologous stem cells, using the
established protocols and procedures at each site.
Peripheral blood samples will be collected for determining the number of CD34+ cells in the
peripheral blood. In addition, a sample will be obtained from each apheresis product to
determine the quantity of CD34+ cells collected after each procedure.
Safety data will be reported according to guidelines provided in the protocol. Adverse
event (AE) guidance is summarised in the protocol. Investigators will grade AEs using the
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE),
Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent
engraftment and graft status. Patients who undergo haematopoietic stem cell transplantation
will be monitored for graft status at 100 days, 6 months, and 12 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant
Genzyme Europe, B.V.
Germany: Federal Institute for Drugs and Medical Devices