The purpose of this study is to determine if the combination of G-CSF and bortezomib is safe and effective in blood cell mobilization.
The study plans to use VELCADE for two doses followed by G-CSF given for 4 doses as is standard for mobilization with G-CSF alone. The rationale for VELCADE prior to the G-CSF is because VELCADE causes thrombocytopenia, similar to how cyclophosphamide is given followed by G-CSF for stem cell mobilization. Usually a cycle of VELCADE for myeloma therapy consists of 4 doses, but this may result in more significant drop in the platelet count. Low platelet counts may preclude adequate stem cell collection. The mobilization with VELCADE and GCSF will be approximately 3 -4 weeks after completion of the initial therapy for the primary disease. Patients meeting eligibility criteria and who give informed consent will be mobilized using bortezomib at 1.3mg/m2 on day -11 and day -8. Subsequently G-CSF will be administered subcutaneously from day -4 to day -1 as a once daily injection at the standard /established dose of 10mcg/kg. Stem cell collection will be done on day 0 per standard of care regimen and protocol with processing of 4 -5 blood volumes. Stem cell enumeration by flow cytometry will be done prior to the collection by flow cytometry. The number of CD 34 positive cells (stem cell phenotype) / kg obtained each day of collection will be noted. G-CSF will be continued daily until adequate numbers of stem cells are obtained for the performance of a single autologous transplant (\> 2.5 million CD 34 cells/kg of weight. Subsequently the data for engraftment of neutrophils and platelets will be monitored as is routine for all patients undergoing autologous transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Bortezomib injection: 1.3mg/m2 11 days before and 8 days before the stem cell collection G-CSF injection: 10mcg/kg on days -4 to day -1 once daily
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kansas Medical Center, Westwood Campus
Westwood, Kansas, United States
Determine the effectiveness of the combination of bortezomib and G-CSF
The primary aim of this single-arm pilot study is to determine the effectiveness of a combination of Bortezomib and G-SCSF in blood stem cell mobilization through the estimation of the proportion of patients receiving treatment that obtain adequate stem cell yield.
Time frame: 100 days after transplant
Assess the safety of the combination of bortezomib and G-CSF
Assess the safety of the study mobilization regimen
Time frame: 365 days after transplant
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