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Sponsored by: |
Genzyme |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00396266 |
Patients with Non-Hodgkin's Lymphoma (NHL) and Multiple Myeloma (MM) who have undergone a cyto-reductive chemotherapy regimen protocol, who are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of AMD3100 to a G-CSF mobilization regimen on the evening prior to apheresis. Patients will undergo mobilization with G-CSF and on each evening prior to apheresis will receive AMD3100. Patients will receive G-CSF in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of (≥5 x 10e6) CD34+ stem cells. All patients will be treated with high dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. Patients will be followed for durability of their transplant for 12 months following transplantation.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma Non-Hodgkin's Lymphoma |
Drug: AMD3100 Procedure: Stem Cell Mobilization |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment With AMD3100 in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients to Increase the Number of Peripheral Blood Stem Cells When Given a Mobilizing Regimen of G-CSF |
Enrollment: | 23 |
Study Start Date: | January 2005 |
Study Completion Date: | December 2007 |
Patients with Non-Hodgkin's Lymphoma (NHL) and Multiple Myeloma (MM) who have undergone a cyto-reductive chemotherapy regimen protocol, who are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of AMD3100 to a G-CSF mobilization regimen on the evening prior to apheresis. Patients will undergo mobilization with G-CSF (10 µg/kg QD) and on each evening prior to apheresis will receive AMD3100 (240 µg/kg). Patients will receive G-CSF(10 µg/kg QD) in the morning followed by apheresis for up to 5 consecutive days in order to collect the target number of (≥5 x 10e6) CD34+ stem cells. All patients will be treated with high dose chemotherapy in preparation for transplantation. Patients will be transplanted with cells obtained from the G-CSF and AMD3100 mobilization regimen. Patients will be followed for durability of their transplant for 12 months following transplantation. In the event that a sufficient number of cells for transplantation are not obtained from the collection, cells may be retained and pooled for transplantation at the Investigator's discretion. The number of CD34+ cells mobilized in the peripheral blood (PB) from the time of the AMD3100 dose to just prior to apheresis and those harvested in the apheresis product will be measured. The number of apheresis sessions required to obtain ≥5 x 10e6 CD34+ cells/kg will also be measured. In addition, the mobilization of NHL tumor cells and the pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of AMD3100 will be examined. Finally, success of the transplantation will be evaluated by the time to engraftment of polymorphonuclear leukocytes (PMNs) as the primary measurement and platelets (PLTs) as the secondary measurement.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Tom Baker Cancer Center | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, British Columbia | |
Vancouver General Hospital, BC Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z 4E3 |
Study Director: | Medical Monitor, MD | Genzyme |
Responsible Party: | Genzyme ( Medical Monitor ) |
Study ID Numbers: | AMD3100-C201 |
Study First Received: | November 2, 2006 |
Last Updated: | May 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00396266 |
Health Authority: | Canada: Health Canada |
Non-Hodgkin's Lymphoma Multiple Myeloma stem cell mobilization AMD3100 autologous transplantation |
Immunoproliferative Disorders JM 3100 Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Lymphoma, small cleaved-cell, diffuse Vascular Diseases Paraproteinemias Hemostatic Disorders |
Multiple Myeloma Lymphatic Diseases Hemorrhagic Disorders Multiple myeloma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms Anti-HIV Agents Neoplasms by Histologic Type Anti-Retroviral Agents |
Immune System Diseases Therapeutic Uses Cardiovascular Diseases Antiviral Agents Pharmacologic Actions |