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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company
• Treatments: JM 3100; Lenograstim; Plerixafor; Sargramostim

Criteria

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