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

Genzyme, a Sanofi Company40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria (Abbreviated List): * MM in first partial response/complete response, first relapse, or second partial/complete response * NHL in first or second partial or complete remission * NHL patients who do not have bone marrow involvement and \< 10% for follicular involvement * MM patients who have stable disease with \< 40% bone marrow involvement * No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * White blood cell count (WBC) \>3.0 x 10\^9/L * Absolute neutrophil count \>1.5 x 10\^9/L * Platelet count \>100 x 10\^9/L Exclusion Criteria (Abbreviated List): * Brain metastases or carcinomatous meningitis * Hypercalcaemia \[\>1 mg/dl above the upper limit of normal (ULN)\] * Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias * Acute Infection

Locations (5)

City of Hope National Medical Center

Duarte, California, United States

Indiana Blood and Marrow Transplantation

Beech Grove, Indiana, United States

University of Rochester Medical Center

Rochester, New York, United States

Oregon Health and Science University

Portland, Oregon, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 13 months

Secondary Outcomes

Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL

The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio. Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).

Time frame: Days 4-5 (first dose of plerixafor to apheresis)

Number of Transplants in Which Participants Achieved Polymorphonuclear Leukocyte (PMN) Engraftment by Day 12 But No Later Than Day 21 Post Peripheral Blood Stem Cell (PBSC) Transplant

Participants were monitored for polymorphonuclear leukocyte (PMN) engraftment as per the local standard of care. The target for engraftment was 12 days after PBSC transplant and no transplant taking longer than 21 days for engraftment.

Time frame: 2 months