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 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
100 days after transplant
Yes
Sunil Abhyankar, MD
Principal Investigator
University of Kansas
United States: Institutional Review Board
11803
NCT01171092
September 2010
October 2013
Name | Location |
---|---|
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
University of Kansas Medical Center, Westwood Campus | Kansas City, Kansas 66205 |