Multiple Myeloma Clinical Trial
Official title:
Plerixafor Rescue Mobilization For Autologous Stem Cell Transplant Patients With Inadequate Response to G-CSF
Plerixafor, administered at a dose of 240 ug/kg, potentiates the effect of granulocyte
colony-stimulating factor (G-CSF) to increase peripheral blood progenitor cells in both
healthy volunteers and cancer patients. Furthermore, in cancer patients, cells collected via
apheresis using Plerixafor and G-CSF have been successfully transplanted. In December 2008,
Plerixafor received approval from the Food and Drug administration for use in combination
with G-CSF to aid in mobilization of progenitor cells for apheresis. The proposed study is
not designed to support approval of a new indication or change in the advertising for
Plerixafor. The route of administration and dosage level are identical to that which is
listed on the package insert. Although Plerixafor is not approved for patients with Hodgkins
Lymphoma, there is no known or theoretic increased risk of the use of this drug in this
patient population.
The study hypothesis for this study is that patients with a circulating CD34+ count < 20
cells/ul after 5 days of mobilization with G-CSF alone will achieve > or equal to 2 X
10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
This is a single-center, Phase 2, open-label study. All patients diagnosed with non-hodgkins
lymphoma, hodgkins disease or multiple myeloma and candidates for autologous transplantation
are eligible to enter into the study. The only change to the standard of care is the
addition of 240 ug/kg Plerixafor following 5 days of (G-CSF) mobilization.
The results of the study will provide both numeric and categorical estimates of measurements
of the safety and efficacy of Plerixafor. The primary efficacy endpoint, Treatment Success,
is a binary response variable categorizing whether the patient was able to mobilize at least
2 X 10(6) CD34+ cells/kg within 3 days of apheresis.
The percentage of patients achieving Treatment Success will be summarized. All AEs will be
followed for 30 days after the last apheresis or until the first dose of ablative
chemotherapy, whichever occurs first. All SAEs will be followed for 6 months post-transplant
or until relapse. All patients who receive at least one dose of Plerixafor will be included
in all summaries of AEs.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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