Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF
An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were
to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only
change to the standard of care was the addition of plerixafor to a mobilization regimen of
chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as
per local practice guidelines and G-CSF (at customary doses) and apheresis was performed.
After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second
apheresis the next day or in the morning of the second day, 6 hours before the second
apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor
dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was
acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
Safety assessment was based on the incidence of adverse event reports. Participant count of AEs (Adverse Events) by severity and by relationship to study drug. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Rochester Medical Center||Rochester, New York 14642|
|City of Hope National Medical Center||Los Angeles, California 91010|
|Indiana Blood and Marrow Transplantation||Indianapolis, Indiana 46202|
|Oregon Health and Science University||Portland, Oregon 97201|