NCT00234169

A Study of Peripheral Blood Progenitor Cells Mobilisation (PBPC) With VTP195183 Plus Granulocyte-Colony Stimulating Factor (G-CSF) Compared to Mobilisation With G-CSF Alone

A Phase I/II Study of Peripheral Blood Progenitor Cells Mobilisation With VTP195183 Plus G-CSF Compared to Mobilisation With G-CSF Alone in Patients With Multiple Myeloma and Lymphoma.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hematopoietic stem cells (HSC) are used to support the administration of high dose chemotherapy for a range of human cancers. For a safe HSC transplantation, a minimum of 5 million HSC per kilogram are required. HSC are collected from the bone marrow by using drugs such as G-CSF (filgrastim) which 'mobilize' them from the bone marrow into the bloodstream. HSC are collected from the bloodstream using an apheresis machine. Between 5 and 60% of patients fail to mobilize the minimum HSC dose required for safe transplantation, and this trial is investigating a way to enhance mobilization to overcome this problem. This trial aims to determine if a new vitamin A derivative is capable of enhancing HSC mobilization when used in conjunction with G-CSF. Patients will undergo two mobilization procedures. They will be given G-CSF alone, or a combination of the study drug plus G-CSF, and their stem cells will be collected. A comparison group of patients will be given G-CSF alone for both mobilizations. Stem cells collected from patients in this trial will be frozen and stored until they are required for transplantation into that patient. At that time, patients will be monitored for how well they recover from their high dose chemotherapy and HSC transplantation.

Conditions

• Multiple Myeloma
• Lymphoma

Interventions

Type	Name	Description
DRUG	VTP195183	VTP195183: 60mg/m2 orally daily G-CSF: 10mcg/kg/day subcutaneously Provision is made for dose reduction of VTP195183 in the event of unexpected dose-limiting toxicities G-CSF10mcg/kg/day will commence on day 1 and will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first. Patients will be treated with VTP195183 alone at 60mg/m2/day from day 1 to day 7. On day 8 VTP195183 will be continued and G-CSF10mcg/kg/day will be added. VTP195183 plus G-CSF will continue until the peripheral blood (PB) CD34+ count falls below baseline, or below 5 x 106/L, whichever happens first.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-10-06
• Last updated: 2012-05-10

Locations

1 site across 1 country: Australia