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Clinical Trial Summary

The purpose of this study is to determine if the combination of G-CSF and bortezomib is safe and effective in blood cell mobilization.


Clinical Trial Description

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01171092
Study type Interventional
Source University of Kansas Medical Center
Contact
Status Completed
Phase Phase 0
Start date September 2010
Completion date December 2014

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