NCT01301963

Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide

Comparison of Plerixafor and G-CSF Versus G-CSF Alone for Stem Cell Mobilization in Patients With Multiple Myeloma Previously Treated With Lenalidomide

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating patients with multiple myeloma (MM) previously treated with lenalidomide. Giving colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored

Detailed description

PRIMARY OBJECTIVES: I. Ability to reach target collection of 5 x 10\^6 CD34+ cells/Kg with =\< 2 days of leukaphereses using one of two mobilization regimens. SECONDARY OBJECTIVES: I. Percentage of patients achieving target goal CD34+ cell dose (as above) in =\< 5 days of leukaphereses. II. Compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other. III. Compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive G-CSF subcutaneously (SC) once daily (QD) on days 1-8. ARM II: Patients receive G-CSF SC QD on days 1-7 and plerixafor SC QD on days 4-7. After completion of study treatment, patients are followed up at 14 days.

Conditions

• Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	plerixafor	Given SC
BIOLOGICAL	filgrastim	Given SC

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-06-01
• First posted: 2011-02-23
• Last updated: 2014-08-06
• Results posted: 2014-08-06

Locations

2 sites across 1 country: United States