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Sponsors and Collaborators: |
Genzyme AnorMED |
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Information provided by: | Genzyme |
ClinicalTrials.gov Identifier: | NCT00322387 |
Patients with Multiple Myeloma (MM) and Non-Hodgkin's Lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus AMD3100. The purpose of this protocol is to determine if, in patients with MM or NHL, AMD3100 added to a chemotherapy and G CSF mobilization regimen can increase the circulating levels of PBSCs by ≥ 2-fold which would be removed by apheresis and to evaluate the success of the transplant by measuring the time to engraftment of PMNs and PLTs.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin Multiple Myeloma |
Drug: AMD3100 Drug: G-CSF (Neupogen) Procedure: Stem cell mobilization Procedure: Apheresis Procedure: Autologous transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Treatment With AMD3100 in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF |
Enrollment: | 44 |
Study Start Date: | January 2004 |
Study Completion Date: | June 2006 |
This is an open label, multi-center, Phase 2 study. Patients with MM or NHL who are to be treated with PBSC autologous transplantation are eligible for this protocol. The only change to the standard of care is the addition of AMD3100 to a mobilization regimen of chemotherapy and G-CSF. Patients will first be given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis will be performed. After the first apheresis, AMD3100 will be given at 10PM, 10 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the AMD3100 dose and the start of apheresis will be measured. The apheresis yields on day one and day two will be compared.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | AMD3100-2104 |
Study First Received: | May 4, 2006 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00322387 |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's Lymphoma Multiple Myeloma Stem cell mobilization |
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 |