RT Journal Article
T1 Plerixafor and granulocyte colony-stimulating factor for first-line steady-state autologous peripheral blood stem cell mobilization in lymphoma and multiple myeloma: results of the prospective PREDICT trial.
A1 Russell, Nigel
A1 Douglas, Kenny
A1 Ho, Anthony D
A1 Mohty, Mohamad
A1 Carlson, Kristina
A1 Ossenkoppele, G J
A1 Milone, Giuseppe
A1 Ortiz Pareja, Macarena
A1 Shaheen, Daniel
A1 Willemsen, Arnold
A1 Whitaker, Nicky
A1 Chabannon, Christian
K1 Europa
K1 Compuestos heterocíclicos
K1 Factor estimulante de colonias de granulocitos
K1 Células madre hematopoyéticas
K1 Trasplante autólogo
K1 Linfoma no Hodgkin
K1 Mieloma múltiple
K1 Estudios multicéntricos como asunto
K1 Toxicidad medicamentosa
AB In Europe, the combination of plerixafor + granulocyte colony-stimulating factor is approved for the mobilization of hematopoietic stem cells for autologous transplantation in patients with lymphoma and myeloma whose cells mobilize poorly. The purpose of this study was to further assess the safety and efficacy of plerixafor + granulocyte colony-stimulating factor for front-line mobilization in European patients with lymphoma or myeloma. In this multicenter, open label, single-arm study, patients received granulocyte colony-stimulating factor (10 μg/kg/day) subcutaneously for 4 days; on the evening of day 4 they were given plerixafor (0.24 mg/kg) subcutaneously. Patients underwent apheresis on day 5 after a morning dose of granulocyte colony-stimulating factor. The primary study objective was to confirm the safety of mobilization with plerixafor. Secondary objectives included assessment of efficacy (apheresis yield, time to engraftment). The combination of plerixafor + granulocyte colony-stimulating factor was used to mobilize hematopoietic stem cells in 118 patients (90 with myeloma, 25 with non-Hodgkin's lymphoma, 3 with Hodgkin's disease). Treatment-emergent plerixafor-related adverse events were reported in 24 patients. Most adverse events occurred within 1 hour after injection, were grade 1 or 2 in severity and included gastrointestinal disorders or injection-site reactions. The minimum cell yield (≥ 2 × 10(6) CD34(+) cells/kg) was harvested in 98% of patients with myeloma and in 80% of those with non-Hodgkin's lymphoma in a median of one apheresis. The optimum cell dose (≥ 5 × 10(6) CD34(+) cells/kg for non-Hodgkin's lymphoma or ≥ 6 × 10(6) CD34(+) cells/kg for myeloma) was harvested in 89% of myeloma patients and 48% of non-Hodgkin's lymphoma patients. In this prospective, multicenter European study, mobilization with plerixafor + granulocyte colony-stimulating factor allowed the majority of patients with myeloma or non-Hodgkin's lymphoma to undergo transplantation with minimal toxicity, providing further data supporting the safety and efficacy of plerixafor + granulocyte colony-stimulating factor for front-line mobilization of hematopoietic stem cells in patients with non-Hodgkin's lymphoma or myeloma.
PB Ferrata Storti Foundation
SN 0390-6078
YR 2013
FD 2013-02-01
LK http://hdl.handle.net/10668/1398
UL http://hdl.handle.net/10668/1398
LA en
NO Russell N, Douglas K, Ho AD, Mohty M, Carlson K, Ossenkoppele GJ, et al. Plerixafor and granulocyte colony-stimulating factor for first-line steady-state autologous peripheral blood stem cell mobilization in lymphoma and multiple myeloma: results of the prospective PREDICT trial. Haematologica. 2013; 98(2):172-8
NO Journal Article; Research Support, Non-U.S. Gov't;. (clinicalTrials.gov identifier: NCT00838357).
DS RISalud
RD May 9, 2025