Multiple Myeloma Clinical Trial
Official title:
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
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of peripheral blood stem cells (PBSCs) by ≥ 2-fold before apheresis, and if transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
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
compared.
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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