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Spots Global Cancer Trial Database for 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.

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Trial Identification

Brief 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.

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

Study ID: NCT00720603

Interventions

Plerixafor

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Medical Monitor

Affiliation: Genzyme, a Sanofi Company

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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