Treatment With AMD3100 in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients to Increase the Number of Peripheral Blood Stem Cells When Given a Mobilizing Regimen of G-CSF
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be
autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter
the study. The only change to the standard of care is the addition of plerixafor to a
granulocyte colony-stimulating factor (G-CSF) mobilization regimen on the day prior to
apheresis. Participants will undergo mobilization with G-CSF (10 mcg/kg each day) and will
receive plerixafor (240 mcg/kg) in the evening prior to apheresis. Participants will undergo
apheresis for up to 5 consecutive days in order to collect the target number of CD34+ stem
cells (≥ 5*10^6 CD34+ cells/kg for either single or tandem transplant). After apheresis, all
participants will be treated with high-dose chemotherapy in preparation for transplantation.
Participants will be transplanted with cells obtained from the G-CSF and plerixafor
mobilization regimen. The increase in CD34+ cells in the peripheral blood from the time of
the plerixafor dose to just prior to apheresis and the number of CD34+ cells in the
apheresis product will be measured. Success of the transplantation(s) will be evaluated by
the time to engraftment of polymorphonuclear leukocytes (PMN). A subpopulation will have
pharmacokinetic and pharmacodynamic analysis done.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants in Overall Safety Summary of Treatment Emergent Adverse Events (TEAE)
Number of participants with treatment emergent adverse events (TEAEs) collected from Day 1 (start of G-CSF mobilization) to the day before starting chemotherapy. AEs were graded by the investigator using the World Health Organization (WHO) Adverse Event Grading Scale and were assessed for severity (mild, moderate, severe) and relatedness to study treatment (5 point scale from 'not related' to 'definitely related').
Day 1 to approximately Day 38 (before start of chemotherapy)
Medical Monitor, MD
Canada: Health Canada