NCT01171092

A Safety Study Looking at the Combination of Velcade and G-CSF in Patients With Myeloma or Lymphoma

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Malignant Lymphoma, Stem Cell Type
• Autologous Transplant

Interventions

Type	Name	Description
DRUG	bortezomib and G-CSF	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

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-01-01
• Completion: 2014-12-01
• First posted: 2010-07-28
• Last updated: 2017-01-11

Locations

2 sites across 1 country: United States