Treatment With AMD3100 in Multiple Myeloma Patients to Mobilize Peripheral Blood Progenitor Cells For Collection and for Transplantation
This study will examine whether 240 µg/kg plerixafor given alone for up to 4 days is safe
and well tolerated in multiple myeloma (MM) patients. In addition, this study determines if
240 µg/kg plerixafor alone can be used to mobilize peripheral blood progenitor cells (PBPCs)
for transplantation in MM patients. The minimum number of CD34+ cells to collect is 2*10^6
CD34+ cells/kg and the target is ≧4*10^6 CD34+ cells/kg. Success of transplant engraftment
will be measured by the number of days to polymorphonuclear leukocytes (PMN) and platelet
(PLT) engraftment. Durability of engraftment will be assessed for a minimum of one year.
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 Who Achieved ≥4*10^6 CD34+ Cells/kg
Number of participants achieving a target of ≥ 4*10^6 CD34+ cells/kg during apheresis for up to 4 consecutive days. Apheresis was performed six hours following treatment with plerixafor 240 µg/kg (alone). Target was calculated as the sum of all daily values collected from central laboratory data over up to 4 apheresis days.
Day 1 up to day 4
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|