NCT01074060

Plerixafor and Filgrastim Following Cyclophosphamide for Stem Cell Mobilization in Patients With Multiple Myeloma

A Phase I/Pilot Study of Intravenous PLERIXAFOR Following Cyclophosphamide Mobilization in Patients With Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: There are different methods of stem cell mobilization, such as using colony-stimulating factors alone or following chemotherapy priming. More recently, the combination of plerixafor and colony-stimulating factors has been shown to enhance stem cell mobilization. This study will assess whether the combination of plerixafor and Granulocyte Colony-Stimulating Factor (G-CSF) is effective following chemotherapy mobilization with cyclophosphamide. PURPOSE: To assess the safety, tolerability, and best dose of intravenous plerixafor following cyclophosphamide priming.

Detailed description

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of intravenous(IV) PLERIXAFOR when given in combination with cyclophosphamide and G-CSF as a mobilization regimen in patients with Multiple Myeloma. SECONDARY OBJECTIVES: I. To determine if intravenous PLERIXAFOR, given with a cyclophosphamide and G-CSF mobilizing regimen, will allow collection of greater than or equal to 5 x 10\^6 CD34+ cells/kg in 2 or less apheresis days. II. To review the timing of intravenous plerixafor administration prior to apheresis and describe our experience. OUTLINE: MOBILIZATION: Patients receive cyclophosphamide intravenously (IV). Patients also receive filgrastim subcutaneously (SC) daily beginning approximately 24 hours later. TREATMENT/APHERESIS: Beginning 10 days after cyclophosphamide, patients receive plerixafor IV over 30 minutes followed by filgrastim SC on each day of apheresis. Following the collection of an adequate number of stem cells, patients undergo high-dose chemotherapy and autologous stem cell rescue. Patients are followed post-autologous stem cell transplant for engraftment. After completion of study treatment, patients are followed periodically.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
DRUG	plerixafor	Given IV
BIOLOGICAL	filgrastim	Given SC
DRUG	cyclophosphamide	Given IV
PROCEDURE	autologous hematopoietic stem cell transplantation	autologous hematopoietic stem cell transplantation
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-02-24
• Last updated: 2013-02-15

Locations

1 site across 1 country: United States