Efficacy and safety of plerixafor for the mobilization/collection of peripheral hematopoietic stem cells for autologous transplantation in Japanese patients with multiple myeloma

2017 ◽  
Vol 106 (4) ◽  
pp. 562-572 ◽  
Author(s):  
Masaki Ri ◽  
Kosei Matsue ◽  
Kazutaka Sunami ◽  
Chihiro Shimazaki ◽  
Akio Hayashi ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Hematopoietic Stem Cells ◽  
Autologous Transplantation ◽  
Japanese Patients ◽  
Efficacy And Safety ◽  
Hematopoietic Stem

Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma

Blood ◽  
2009 ◽  
Vol 113 (23) ◽  
pp. 5720-5726 ◽  
Author(s):  
John F. DiPersio ◽  
Edward A. Stadtmauer ◽  
Auayporn Nademanee ◽  
Ivana N. M. Micallef ◽  
Patrick J. Stiff ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Hematopoietic Stem Cells ◽  
Primary Endpoint ◽  
Controlled Study ◽  
Double Blind ◽  
Hematopoietic Stem ◽  
Injection Site Reactions ◽  
Cd34 Cells ◽  
Stimulating Factor

Abstract This phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor (G-CSF) in mobilizing hematopoietic stem cells in patients with multiple myeloma. Patients received G-CSF (10 μg/kg) subcutaneously daily for up to 8 days. Beginning on day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until more than or equal to 6 × 106 CD34+ cells/kg were collected. The primary endpoint was the percentage of patients who collected more than or equal to 6 × 106 CD34+ cells/kg in less than or equal to 2 aphereses. A total of 106 of 148 (71.6%) patients in the plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint (P < .001). A total of 54% of plerixafor-treated patients reached target after one apheresis, whereas 56% of the placebo-treated patients required 4 aphereses to reach target. The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions. Plerixafor and G-CSF were well tolerated, and significantly more patients collected the optimal CD34+ cell/kg target for transplantation earlier compared with G-CSF alone. This study is registered at www.clinicaltrials.gov as #NCT00103662.

scholarly journals Mobilization of Hematopoietic Stem Cells with Lenograstim in Healthy Donors: Efficacy and Safety Analysis According to Donor Age

2015 ◽  
Vol 21 (5) ◽  
pp. 881-888 ◽  
Author(s):  
Massimo Martino ◽  
Erminio Bonizzoni ◽  
Tiziana Moscato ◽  
Anna Grazia Recchia ◽  
Roberta Fedele ◽  
...  
Keyword(s):  
Stem Cells ◽  
Hematopoietic Stem Cells ◽  
Safety Analysis ◽  
Efficacy And Safety ◽  
Donor Age ◽  
Hematopoietic Stem ◽  
Healthy Donors
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