This is a Multi-center, Single Arm, Open Label Study Intended to Provide Expanded Access to Plerixafor for Patients With Non-Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) Who Are to Receive Treatment With an Autologous Peripheral Stem Cell Transplant. (EAP)

This is an expanded access trial for Non-Hodgkin's Lymphoma focused on measuring Autologous Stem Cell Transplant Read More

Inclusion Criteria:

• Diagnosis of MM, NHL, or HD.
• Eligible for a planned autologous peripheral stem cell transplantation.
• Written informed consent.
• At least 18 years of age (inclusive).
• Easter Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate cardiac, renal, and pulmonary function sufficient to undergo apheresis and transplantation, I.e., eligible by institutional standards for autologous stem cell transplant.
• Male and female patients of childbearing potential agree to use appropriate form of contraception (i.e., condom, diaphragm cervical cap, etc.) while on study and for at least 3 months following the last treatment. Female patients of child-producing potential must have a negative serum pregnancy test confirmed within 7 days of beginning mobilization therapy.
• White blood cell (WBC) count greater than or equal to 2.5x10^9/L.
• Absolute neutrophil count (ANC) greater than or equal to 1.5x10^9/L.
• Platelet count greater than or equal to 100x10^9/L.
• Serum creatinine less than or equal to 2.2 mg/ dL.
• AST/SGOT, ALT/SGPT, and total bilirubin less than 2.5 x upper limit of normal (ULN).

Exclusion Criteria:

• History of acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), acute myelocytic leukemia (AML), chronic myelocytic leukemia (CML), myelodysplastic syndrome (MDS), plasma cell leukemia or other leukemia.
• Failed previous CD34+ cell collection attempts.
• Prior autologous or allogenic transplantation.
• less than 4 weeks since last anti-cancer therapy (including chemotherapy, biologic/immunologic, radiation) or less than 6 weeks if prior therapy was with nitrosourea or mitomycin (for therapies with prolonged effects, a treatment-free interval of at least 2 half-lives should be considered) with the exception of the following: Treatment with thalidomide, dexamethasone, lenalidomide (Revlimid®), and/or bortezomib (Velcade®) is allowed up to 7 days prior to the first dose of G-CF.
• Bone marrow involvement greater than 20% assessed based on the most recent bone marrow aspirate or biopsy.
• Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization.
• HIV positive.
• Active hepatitis B (positive HBsAg) or hepatitis C.
• Acute infection (febrile, i.e., temperature greater than 38 degrees Celsius/100.4 degrees Fahrenheit) within 24 hours prior to dosing or antibiotic therapy within 1 week of enrollment.
• Hypercalcemia as evidenced by greater than 1 mg/dL above ULN.
• Previously received investigational therapy with 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase.
• Central nervous system involvement including brain metastases of leptomeningeal disease.
• Pregnant or nursing women.
• ECG or study result (exercize study, scan) indicative of previously undiagnosed cardiac ischemia or a history of clinically significant rhythm disturbance (arrhythmias), or other conduction abnormality in the last year that in the opinion of the Investigator warrants exclusion of the subject from the trial.
• Co-morbid conditions(s), which in the opinion of the Investigator, renders the patient at high risk from treatment complications or impairs their ability to comply with the study treatment and protocol.