NCT01095757

Evaluation of the Drug Plerixafor in Combination With Chemotherapy and G-CSF for Stem Cell Collection

Evaluation of Plerixafor (Mozobil ™, AMD3100) in Combination With Chemotherapy and G-CSF for CD34+ Cell Mobilization

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether the addition of the drug plerixafor to treatment with chemotherapy and G-CSF can better activate your bone marrow stem cells to improve the chances of transplant. The study will look for the activation of a certain type of blood cell, called CD34+ cells in patients who receive plerixafor, chemotherapy and G-CSF. The investigators will follow the number of patients that achieve the target numbers of CD34+ cells. The number of patients achieving the target level of CD34+ cells, and the total number of CD34+ cells, will be compared to the numbers in previous studies testing just chemotherapy and G-CSF, without plerixafor. The investigators will also test the safety of the combination of plerixafor with chemotherapy and G-CSF and look at the success of the transplantation after 12 months.

Conditions

• Myeloma
• Lymphoma

Interventions

Type	Name	Description
DRUG	Plerixafor	240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is \> 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-05-01
• Completion: 2014-02-01
• First posted: 2010-03-30
• Last updated: 2014-09-29
• Results posted: 2014-09-12

Locations

1 site across 1 country: United States