A Multi-centre, Open Label, Single-arm Study Intended to Further Investigate the Safety and Efficacy of Plerixafor as a Front-line Mobilisation Agent in Combination With G-CSF in Patients With Lymphoma or MM (Multiple Myeloma). (PREDICT)
|Lymphoma (Non-Hodgkin's Lymphoma) Hodgkin's Disease or Multiple Myeloma Front Line Mobilization Transplantation||Drug: Generic = Plerixafor||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Plerixafor and G−CSF for the Mobilisation of Peripheral Blood Stem Cells for Autologous Stem Cell Transplantation in Patients With Non−Hodgkin's Lymphoma (NHL), Hodgkin's Disease (HD) or Multiple Myeloma (MM) − Safety Study in a General Autologous Transplant Population|
- To confirm the safety profile of plerixafor to mobilise stem cells when used in patients with lymphoma or MM who are eligible to undergo treatment with an autologous haematopoietic stem cell transplant [ Time Frame: 24 months ]
- To assess efficacy of plerixafor and granulocyte-colony stimulating factor (G-CSF) as a mobilisation regimen as measured by the number of CD34+ cells collected in each apheresis session [ Time Frame: After each dose of plerixafor ]
- To assess the clinical effectiveness of plerixafor and G-CSF mobilised stem cells by examining haematopoietic cell engraftment and graft status [ Time Frame: After transplantation ]
- To examine the influence of CD34+ cell dose infused on time to engraftment, engraftment and graft status [ Time Frame: After transplantation ]
|Study Start Date:||September 2008|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Plerixafor added to a G-CSF Mobilisation regimen
Drug: Generic = Plerixafor
240µg/kg administered as an SC injection 10 to 11 hours prior to initiation of apheresis. Daily administration for 1 up to 5 consecutive days
Patients with advanced or treatment-refractory Multiple Myeloma (MM), Hodgkin's Disease (HD) and Non-Hodgkin's Lymphoma (NHL) may be successfully treated with high dose chemotherapy followed by autologous transplantation of peripheral blood stem cells (PBSCs). Successful engraftment of peripheral blood stem cells (PBSCs) is well correlated with the number of CD34+ cells infused.
Stem cell collection with plerixafor could have a major benefit by increasing the circulating number of PBSCs and decreasing the number of apheresis sessions required to collect a sufficient number of PBSCs for transplant.
This is a multi-centre, open label, single-arm study intended to further investigate the safety and efficacy of plerixafor in patients with NHL, HD, or MM. Patients who have previously failed stem cell mobilisation attempts or who have previously received more than one autologous or any allogeneic stem cell transplant are not eligible.
Screening for eligibility will take place up to 30 days before the first dose of G-CSF. Patients will receive a stem cell mobilisation regimen consisting of plerixafor and G-CSF. Patients will be given G-CSF for 4 consecutive days in the morning. Starting on the evening of Day 4, plerixafor will be administered subcutaneously (SC). The plerixafor dose will be timed to allow for a 10- to 11-hour interval between the plerixafor dosing and the initiation of apheresis. Patients may continue to receive the evening dose of plerixafor then G-CSF the next morning followed by apheresis for up to a total of 5 apheresis procedures until a minimum of at least 5 x 106 CD34+ cells/kg for NHL/HD or 6 x 106 CD34+ cells/kg for MM are collected. More cells may be collected if done within the 5 apheresis procedures. Stem cell collection will take place using standard procedures.
Following the last apheresis, patients will undergo pre-transplant myeloablative chemotherapy followed by transplantation of the collected autologous stem cells, using the established protocols and procedures at each site.
Peripheral blood samples will be collected for determining the number of CD34+ cells in the peripheral blood. In addition, a sample will be obtained from each apheresis product to determine the quantity of CD34+ cells collected after each procedure.
Safety data will be reported according to guidelines provided in the protocol. Adverse event (AE) guidance is summarised in the protocol. Investigators will grade AEs using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Efficacy will be based on the quantity of CD34+ cells harvested and the subsequent engraftment and graft status. Patients who undergo haematopoietic stem cell transplantation will be monitored for graft status at 100 days, 6 months, and 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00838357
|Hôpital du Haut Lévêque|
|Hôpital Lyon Sud|
|Institut Paoli Calmettes|
|CHU Hotel-Dieu Université de Nantes|
|Institut Gustave Roussy|
|Charité - Campus Benjamin Franklin|
|Klinikum der Universität zu Köln|
|Universitätsklinikum Carl Gustav Carus|
|Klinikum Nürnberg Nord|
|L. & A. Seragnoli, University of Bologna|
|Azienda Ospedaliera S. Martino|
|VU Medisch Centrum|
|Hospital Santa Creu y Sant Pau|
|Hospital Universitario de Salamanca|
|Hospital la Fe|
|Karolinska Universitetssjukhuset Huddinge|
|Glasgow, United Kingdom|
|St James's University Hospital|
|Leeds, United Kingdom|
|King's college Hospital|
|London, United Kingdom|
|Nottingham University NHS Trust|
|Nottingham, United Kingdom|
|Study Director:||Medical Monitor||Genzyme Europe, B.V.|