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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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