Autologous Transplant Clinical Trial
Official title:
A Pilot Trial to Assess Mobilization of Hematopoietic Progenitor Cells With a Combination of Bortezomib and G-CSF in Patients Undergoing Autologous Transplant for Myeloma and Lymphoma
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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