NCT01339572

Clinical And Economic Impact Of Upfront Plerixafor In Autologous Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol will investigate the effectiveness of plerixafor in the up-front setting in avoiding a second round of mobilization and whether this translates into a clinical and economic benefit.

Detailed description

Peripheral blood stem cells are now considered the standard source of stem cells for autologous stem cell transplants. Unfortunately, there is still a 20-30% chance that inadequate numbers of stem cells will be collected, resulting in prolonged recovery of cell counts after transplantation and increased transfusion dependence. There is also a significant economic burden associated with remobilization and a risk that delays in collecting sufficient numbers of stem cells can result in an increased chance of disease recurrence prior to transplantation.

Conditions

• Non-Hodgkin's Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Plerixafor	240 mcg/kg/day based on ideal body weight will be given for the following conditions: 1. Pre-apheresis peripheral blood CD34+ count \<20 cells/μL on day 5. 2. Estimated CD34+ cell collection is \< 25% of target cell dose after 1 day of apheresis. 3. Estimated CD34+ cell collection is \< 50% of target cell dose after 2 days of apheresis.
DRUG	Filgrastim	All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient: * Standard risk: 5 μg/kg SQ BID. * High risk: 10 μg/kg SQ BID.

Timeline

• Start date: 2011-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2011-04-20
• Last updated: 2017-08-01

Locations

1 site across 1 country: United States