Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation

The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.

A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.

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.

Inclusion Criteria:

• Diagnosis of multiple myeloma in first or second complete or partial remission
• >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
• Recovered from all acute toxic effects of prior chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• White Blood Cell count (WBC) > 2.5*10^9/L
• Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
• Platelet (PLT) > 100*10^9/L
• Serum creatinine <=2.2 mg/dL
• Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
• Negative for HIV

Exclusion Criteria):

• Failed previous stem cell collection
• Previous stem cell transplantation
• Brain metastases or myelomatous meningitis
• Radiation to ≥ 50% of the pelvis
• Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
• Received bone-seeking radionuclides (e.g. holmium)
• A residual acute medical condition resulting from prior chemotherapy