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 non-Hodgkin's lymphoma and multiple myeloma who have undergone prior
cyto-reductive chemotherapy and are to be autologously transplanted will be treated with a
combination of plerixafor and granulocyte colony-stimulating factor (G-CSF) mobilization
regimen on the day prior to apheresis. The only change to standard of European care is the
addition of plerixafor to a G-CSF mobilizing regimen. Participants will undergo mobilization
with G-CSF (10 µg/kg each day) and on each day prior to apheresis will receive plerixafor
(240 µg/kg). Participants will undergo apheresis for up to 5 consecutive days in order to
collect the target number of (≥ 5*10^6) CD34+ stem cells/kg. Participants will be
transplanted with cells obtained from the G-CSF and plerixafor mobilization regimen. The
number of CD34+ cells mobilized in the peripheral blood from the time of the plerixafor dose
to just prior to apheresis and those harvested in the apheresis product will be measured.
The number of apheresis sessions required to obtain ≥ 5*10^6 CD34+ cells/kg will also be
measured. Success of the transplantation(s) will be evaluated by the time to engraftment of
poly-morphonuclear leukocytes (PMN) and platelets (PLT). Participants will be followed for
durability of their transplant for 12 months following transplantation.
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: Non-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 (approximately day 38). 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 step scale from 'not related' to 'definitely related').
Day 1 to approximately Day 38 (before start of chemotherapy)
Germany:Bundesinstitut für Arzneimittel und Medizinprodukte