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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

18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma

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Trial Information

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

The Expanded Access Program (EAP)(protocol number MOZ00607) is an open label study intended
to provide access to plerixafor for patients with non-Hodgkin's Lymphoma, Hodgkin's Disease,
or Multiple Myeloma who are to receive treatment with an autologous hematopoietic stem cell
transplant. Patients who have previously failed stem cell mobilization attempts or who have
previously received an autologous or allogeneic stem cell transplant are not eligible to
enroll in this program. The standard of care regimen for stem cell mobilization includes a
growth factor, G-CSF, to increase peripheral blood stem cells. Plerixafor is given on the
evening prior to doses of standard treatment with G-CSF. The combination of G-CSF and
plerixafor has the potential to increase the number of circulating stem cells. The stem
cells develop into specialized white blood cells and platelets that are necessary for immune
system function and normal blood clotting. The stem cells are removed by a process called
apheresis, in which blood is drawn from the patient, the stem cells are separated from the
plasma, and the plasma is returned to the patient. The separated stem cells are frozen,
similar to the blood banking process. The patient then receives chemotherapy according to
the institutional standard. After chemotherapy, stem cell transplant is intended to
replenish cells in the bone marrow that may be destroyed by chemotherapy.

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

- 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

- 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.

Type of Study:

Expanded Access

Study Design:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Autologous Stem Cell Transplant
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell