An Observational Study of Plerixafor Mobilization Rescue for Autologous Stem Cell Transplant Patients With Inadequate Response to 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. At total of 20
patients will be enrolled. Enrollment will be stratified such that a total of 10 subjects
will carry the diagnosis of multiple myeloma and have received prior lenalidomide therapy.
The other 10 patients will carry the diagnosis of non-hodgkins lymphoma, hodgkins disease or
multiple myeloma and not have prior therapy with lenalidomide.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess, among patients with < 20 CD34+ cells/ul after 5 days of mobilization with G-CSF alone, the percentage who achieve > or equal to 2 X 10(6)CD34+ cells/kg within 3 days of apheresis after receiving Plerixafor with G-CSF.
5 days after receiving G-CSF
Mitchell Horwitz, MD
United States: Institutional Review Board
|Duke University Medical Center||Durham, North Carolina 27710|