TY - JOUR
T1 - Plerixafor and G-CSF for autologous stem cell mobilization in patients with NHL, Hodgkin's lymphoma and multiple myeloma
T2 - Results from the expanded access program
AU - Shaughnessy, P.
AU - Uberti, J.
AU - Devine, S.
AU - Maziarz, R. T.
AU - Vose, J.
AU - Micallef, I.
AU - Jacobsen, E.
AU - McCarty, J.
AU - Stiff, P.
AU - Artz, A.
AU - Ball, E. D.
AU - Berryman, R.
AU - Dugan, M.
AU - Joyce, R.
AU - Hsu, F. J.
AU - Johns, D.
AU - McSweeney, P.
N1 - Funding Information:
This study was sponsored by Sanofi Oncology (previously Genzyme Corporation). PS, RTM, JMC, SD, MD and PMS received honoraria and research funding from Genzyme. IM, JV and PS received research funding from Sanofi/Genzyme. FJH is a former Genzyme employee and is now an employee of Zyngenia, Inc. DJ is an employee of Sanofi Oncology (formerly Genzyme). All the other author declare no conflicts of interest.
PY - 2013/6
Y1 - 2013/6
N2 - Before US regulatory approval, an expanded access program provided plerixafor to patients with non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma (MM) who had not previously failed mobilization and were otherwise candidates for auto-SCT. Patients received granulocyte-CSF (G-CSF) 10 mcg/kg daily and plerixafor 0.24 mg/kg starting on day 4 with apheresis on day 5; all repeated daily until collection was complete. Overall, 104 patients received ≥1 dose of plerixafor. The addition of plerixafor to G-CSF resulted in a median threefold increase in peripheral blood CD34+ cell count between days 4 and 5. Among 43 NHL patients, 74% met the target of ≥5 × 10 6 CD34+ cells/kg (median, 1 day apheresis, range 1-5 days); among 7 HD patients, 57% met the target of ≥5 × 106 CD34+ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89% met the target of ≥6 × 106 CD34+ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93% of patients had ≥2 × 106 CD34+ cells/kg collected within 1-3 days. Plerixafor-related toxicities were minimal. Engraftment kinetics, graft durability and transplant outcomes demonstrated no unexpected outcomes. Efficacy and safety results were similar to results in phase II and III clinical trials.
AB - Before US regulatory approval, an expanded access program provided plerixafor to patients with non-Hodgkin's lymphoma (NHL), Hodgkin's lymphoma (HD) or multiple myeloma (MM) who had not previously failed mobilization and were otherwise candidates for auto-SCT. Patients received granulocyte-CSF (G-CSF) 10 mcg/kg daily and plerixafor 0.24 mg/kg starting on day 4 with apheresis on day 5; all repeated daily until collection was complete. Overall, 104 patients received ≥1 dose of plerixafor. The addition of plerixafor to G-CSF resulted in a median threefold increase in peripheral blood CD34+ cell count between days 4 and 5. Among 43 NHL patients, 74% met the target of ≥5 × 10 6 CD34+ cells/kg (median, 1 day apheresis, range 1-5 days); among 7 HD patients, 57% met the target of ≥5 × 106 CD34+ cells/kg (median, 2 days apheresis, range 1-3); and among 54 MM patients, 89% met the target of ≥6 × 106 CD34+ cells/kg (median, 1 day apheresis, range 1-4). Overall, 93% of patients had ≥2 × 106 CD34+ cells/kg collected within 1-3 days. Plerixafor-related toxicities were minimal. Engraftment kinetics, graft durability and transplant outcomes demonstrated no unexpected outcomes. Efficacy and safety results were similar to results in phase II and III clinical trials.
KW - autologous transplant
KW - mobilization
KW - plerixafor
UR - http://www.scopus.com/inward/record.url?scp=84879113739&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84879113739&partnerID=8YFLogxK
U2 - 10.1038/bmt.2012.219
DO - 10.1038/bmt.2012.219
M3 - Article
C2 - 23178544
AN - SCOPUS:84879113739
SN - 0268-3369
VL - 48
SP - 777
EP - 781
JO - Bone marrow transplantation
JF - Bone marrow transplantation
IS - 6
ER -