Effect of AMD3100 (240µg/kg) on the Apheresis Yield of CD34+ Cells When Given To Multiple Myeloma or Non-Hodgkin's Lymphoma Patients Predicted to be Unable to Mobilize ≥2 x 10^6 CD34+ Cells in Three Apheresis Days When Given G-CSF Alone
A Phase 2, single-center, open-label study to assess the safety and hematological activity
of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who
were predicted to be unable to mobilize ≥2*10^6 CD34+ cells/kg within 3 apheresis days. The
only change to the standard of care was the addition of plerixafor to a G-CSF mobilization
regimen on the day prior to apheresis.
Following screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg
every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the
On Day 5, if the patient's peripheral CD34+ cell count was <5 cells/µl or ≥20 cells/µl, the
patient did not enter this study and was treated as per the policy of the study site.
On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the
patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that
evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor
followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of
apheresis or until ≥5*10^6 cells/kg are collected.
On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive),
then he/she underwent apheresis that day. If this apheresis yield was <1.3*10^6 CD34+
cells/kg, then the patient was predicted to be unlikely to collect ≥2*10^6 CD34+ cells/kg in
≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the
apheresis yield on Day 5 was ≥1.3*10^6 CD34+ cells/kg, then the patient did not enter the
The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis
approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis
yield was at least double the apheresis yield on Day 5, then the patient received another
10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after
receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and
apheresis was repeated for up to a total of 3 days of apheresis or until ≥5*10^6 cells/kg
All patients, after the completion of apheresis procedures (or after ≥5*10^6 cells/kg were
collected), received high-dose chemotherapy in preparation for transplantation. Patients
were transplanted with cells collected after receiving plerixafor with G-CSF. However, if
there were insufficient cells, cells collected after receiving plerixafor with G-CSF could
be pooled with cells collected after receiving G-CSF alone.
Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells
harvested during apheresis.
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 Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days
The number of patients with a circulating CD34+ count >= 5 and < 20 cells/ml after 5 days of mobilization with G-CSF alone who achieved cumulative apheresis yields of ≥2*10^6 CD34+ cells/kg within 3 days of apheresis after receiving G-CSF plus plerixafor. Outcome was based on laboratory results from a central lab.
approximately days 6-9
United States: Food and Drug Administration
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