NCT00322387

Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Lymphoma, Non-Hodgkin
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	G-CSF and plerixafor	G-CSF and plerixafor were administered as described in the treatment arms.

Timeline

• Start date: 2004-04-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2006-05-05
• Last updated: 2014-03-13
• Results posted: 2010-07-14

Locations

5 sites across 1 country: United States