A Safety Study Looking at the Combination of Velcade and G-CSF in Patients With Myeloma or 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.
Malignant Lymphoma, Stem Cell Type
Drug: bortezomib and G-CSF
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Determine the effectiveness of the combination of bortezomib and G-CSF [ Time Frame: 100 days after transplant ] [ Designated as safety issue: Yes ]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.
- Assess the safety of the combination of bortezomib and G-CSF [ Time Frame: 365 days after transplant ] [ Designated as safety issue: Yes ]Assess the safety of the study mobilization regimen
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: bortezomib and G-CSF||
Drug: bortezomib and G-CSF
1.3mg/m2 11 days before and 8 days before the stem cell collection
10mcg/kg on days -4 to day -1 once daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171092
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|University of Kansas Medical Center, Westwood Campus|
|Westwood, Kansas, United States, 66205|
|Principal Investigator:||Sunil Abhyankar, MD||University of Kansas Medical Center|