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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00720603 |
The purpose of this program is to provide expanded access to plerixafor for patients with NHL, HD, or MM who are to receive treatment with an autologous peripheral stem cell transplant.
Condition | Intervention |
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Non-Hodgkin's Lymphoma Hodgkin's Disease Multiple Myeloma |
Drug: Plerixafor |
Study Type: | Expanded Access |
Official 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 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Female patients of child-producing potential must have a negative serum pregnancy test confirmed within 7 days of beginning mobilization therapy.
Exclusion Criteria:
Responsible Party: | Genzyme Corporation ( Medical Monitor ) |
Study ID Numbers: | MOZ00607 |
Study First Received: | July 21, 2008 |
Last Updated: | July 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00720603 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autologous Stem Cell Transplant |
Immunoproliferative Disorders JM 3100 Hodgkin Lymphoma, Adult Hematologic Diseases Blood Protein Disorders Blood Coagulation Disorders Vascular Diseases Hodgkin's Disease Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Hemorrhagic Disorders Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Hodgkin Disease Neoplasms, Plasma Cell |
Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Blood Protein Disorders Vascular Diseases Paraproteinemias Hemostatic Disorders Multiple Myeloma |
Lymphatic Diseases Neoplasms Hemorrhagic Disorders Cardiovascular Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma Neoplasms, Plasma Cell |