Calendario›SNY›G-CSF plus plerixafor
G-CSF plus plerixafor
AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone
Ensayo de Sanofi en Multiple Myeloma · Lymphoma, Non-Hodgkin's (del registro, en inglés).
Más ensayos de: Mieloma múltiple.
- Fase
- Fase 2
- Estado
- Interrumpido
- Participantes
- 5
- Centros
- 1
- Fin del objetivo primario
- jul 2005
Qué significa cada fase y cada estado.
Estudio de intervención, no aleatorizado, abierto. Comenzó en abr 2005.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Enrollment terminated in 2005 to focus on Phase 3 study enrollment.».
Qué mide
Number of Patients Who Achieved ≥2*10^6 CD34+ Cells/kg Following Treatment With Plerixafor 240 µg/kg and G-CSF for up to 3 Consecutive Days (approximately days 6-9) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the study if they had undergone cyto-reductive chemotherapy, were to undergo autologous transplantation, and met the inclusion/exclusion criteria. The purpose of this protocol was to determine whether plerixafor in combination with Granulocyte Colony Stimulating Factor (G-CSF) can increase the circulating levels of peripheral blood stem cells (PBSCs) in patients whose peripheral CD34+ counts remain low after treatment with G-CSF alone, whether it was safe, and whether transplantation with the apheresis product was successful, as measured by time to engraftment of polymorphonuclear leukocytes (PMNs) and platelets (PLTs).
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00395967), actualizada en abr 2015.