PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma — PAV  

Myeloma Clinical Trial

Official title: PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma. A Pilot Phase II Study.

Status Completed

Clinical Trial Summary

High-dose chemotherapy with autologous stem cell support is the current standard procedure in the first-line treatment in younger patients with myeloma fit for intensive treatment. Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and autologous stem cell transplant. In this trial the intravenous application of Plerixafor is being investigated in respect of the capability of the mobilization of stem cells from the bone marrow into the peripheral blood. In contrast to the twice daily application of G-CSF (eg. Neupogen) for several days, Plerixafor has to be injected just one-time.

Clinical Trial Description

Background

High-dose chemotherapy with autologous stem cell support is the current standard procedure in the first-line treatment in younger patients with myeloma fit for intensive treatment. Current practice in Switzerland for stem cell mobilization is the combination of chemotherapy and G-CSF stimulation in myeloma patients fit for high-dose chemotherapy with melphalan and autologous stem cell transplant. For mobilization chemotherapy, a single dose of vinorelbine is commonly used, producing mild myelosuppression. G-CSF is started at day 4 on a daily basis, allowing stem cell apheresis usually at day 8. In a subsequent study, we evaluated the use of pegylated G-CSF given as a single injection at day 4 together with vinorelbine. We found this regimen equally feasible, reliable and allowing collection of stem cells in an equally high percentage. In the current proposal, we suggest to continue this line of research investigating the mobilization using chemotherapy with vinorelbine. We propose to study the feasibility of this mobilization chemotherapy in the absence of growth factors, thus without G-CSF, in combination with Plerixafor.

Objective

Primary objective: To assess the feasibility of collection of > 6 million CD34+ peripheral blood stem cells/kg body weight in 2 days.

Secondary objectives: Assessment of safety of plerixafor during mobilization and collection of peripheral blood stem cells; feasibility of intravenous plerixafor application and stem cell apheresis in a one-day procedure on an ambulatory basis; evaluation of engraftment of peripheral blood stem cells mobilized by vinorelbine and plerixafor; evaluation of the costs for mobilization with plerixafor.

Methods

Chemotherapy with vinorelbine is given at a standard dose at day 1, on an ambulatory basis.

In part A (10 patients), G-CSF is given s.c., divided in two daily doses starting at day 4 until collection of stem cells. Plerixafor is given as an i.v. application on day 8 in the dose of 240 microg/kg b.w. Stem cell collection is initiated 4 hours later at day 8, if at least 20 x 103 of CD34+ cells / ml peripheral blood are detected. In case of insufficient collection, the procedure is repeated at day 9, including repetition of plerixafor application.

Part B (30 patients): If the combination of plerixafor and vinorelbine is found feasible and in the absence of unexpected toxicity, additional 30 patients will be studied in part B of this study. No G-CSF will be administered in part B, otherwise the treatment plan is as it is in part A.

High dose Melphalan will be used as conditioning regimen. After transplantation, G-CSF will be given to subjects starting at day +5 after PBPC reinfusion. ;

Study Design

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT01220375
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Status: Completed
• Phase: Phase 2
• Start date: April 2010
• Completion date: October 2013