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.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00720603
• Date of registration: 21/07/2008
• Primary sponsor: Genzyme
• Public title: 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
• Scientific title: Expanded Acess Study of Plerixafor and G-CSF for the Mobilization and Collection of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non-Hodgkin's Lymphoma, Hodgkin's Disease or Multiple Myeloma
• Date of first enrolment: November 2003
• Recruitment status: No longer available
• URL: http://clinicaltrials.gov/show/NCT00720603
• Study type: Expanded Access
• Study design: N/A

Contacts

• Name: Medical Monitor
• Affiliation: Genzyme

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hodgkin's Disease

Multiple Myeloma

Non-Hodgkin's Lymphoma

Intervention(s)

Drug: Plerixafor

Secondary ID(s)

MOZ00607

Source(s) of Monetary Support

Please refer to primary and secondary sponsors