Clinical trial NCT00395967
Conditions: Multiple Myeloma Lymphoma, Non-Hodgkin's
Keywords: Non-Hodgkin's Lymphoma Multiple Myeloma stem cell mobilization autologous transplantation AMD3100
Sponsor: Genzyme, a Sanofi Company
Start date: 2005-04-01; Completion date: 2006-08-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria.

The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).

Detailed description:
A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. The only change to the standard of care was the addition of plerixafor to a G-CSF mobilization regimen on the day prior to apheresis.

Following screening procedures, eligible patients undergo mobilization with G-CSF (10 µg/kg every day) for 5 days and their peripheral blood (PB) CD34+ cell count was measured on the fifth day.

On Day 5, if the patient's peripheral CD34+ cell count was \<5 cells/µl or ≥20 cells/µl, the patient did not enter this study and was treated as per the policy of the study site.

On Day 5, if the patient's peripheral CD34+ cell count was 5 to 7 cells/µl (inclusive), the patient did not undergo apheresis that day, but did receive plerixafor (240 µg/kg) that evening and G-CSF followed by apheresis the next morning. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5\*10\^6 cells/kg are collected.

On Day 5, if the patient's peripheral CD34+ cell count was 8 to 19 cells/µl (inclusive), then he/she underwent apheresis that day. If this apheresis yield was \<1.3\*10\^6 CD34+ cells/kg, then the patient was predicted to be unlikely to collect ≥2\*10\^6 CD34+ cells/kg in ≥3 days of apheresis and received plerixafor (240 µg/kg) that evening. However, if the apheresis yield on Day 5 was ≥1.3\*10\^6 CD34+ cells/kg, then the patient did not enter the study.

The next morning (Day 6), eligible patients received G-CSF (10 µg/kg) and began apheresis approximately 10 to 11 hours after the previous evening plerixafor dose. If the apheresis yield was at least double the apheresis yield on Day 5, then the patient received another 10:00 pm dose of plerixafor and underwent apheresis again the next morning (Day 7) after receiving G-CSF. The evening dose of plerixafor followed the next morning by G-CSF and apheresis was repeated for up to a total of 3 days of apheresis or until ≥5\*10\^6 cells/kg were collected.

All patients, after the completion of apheresis procedures (or after ≥5\*10\^6 cells/kg were collected), received high-dose chemotherapy in preparation for transplantation. Patients were transplanted with cells collected after receiving plerixafor with G-CSF. However, if there were insufficient cells, cells collected after receiving plerixafor with G-CSF could be pooled with cells collected after receiving G-CSF alone.

Hematological activity of plerixafor was evaluated by assessing the number of CD34+ cells harvested during apheresis.

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.

Arms: arm 1: Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\*10\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.
Interventions: intervention 1: G-CSF plus plerixafor
Intervention descriptions: intervention 1: Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

Protocol documents: