Seok Jin Kim

Comparison of outcomes after autologous stem cell transplantation between myeloma patients with skeletal and soft tissue plasmacytoma.

We aimed to compare the characteristics of skeletal and soft tissue plasmacytomas and to analyze clinical outcomes and prognostic factors of autologous stem cell transplantation (ASCT) in multiple myeloma (MM) patients with plasmacytoma. We retrospectively reviewed data from 93 myeloma patients with detectable extramedullary (EM) plasmacytoma at diagnosis or during the course of the disease, who underwent ASCT. Soft tissue plasmacytoma occurred more frequently in male patients and had higher levels of serum β2‐microglobulin and lactate dehydrogenase and high frequency of advanced disease according to International Staging System compared to the skeletal plasmacytoma group. Both soft tissue and skeletal plasmacytoma groups showed similar plasmacytoma relapse patterns after ASCT and relapsed with EM plasmacytoma slightly more frequently in the bone compared to soft tissue sites. Compared to patients with skeletal plasmacytoma, patients with soft tissue plasmacytoma had worse median progression‐free survival (PFS) (12 vs. 28 months) (P = 0.001) and overall survival (OS) (37 vs. 67 months) (P = 0.037) after ASCT. In a multivariate analysis, soft tissue plasmacytoma was an only independent poor prognostic factor for both PFS (HR, 2.398; 95% CI, 1.304–4.410) and OS (HR, 2.811; 95% CI, 1.107–7.135) after ASCT. These results demonstrate that, even though ASCT achieved a strong response in myeloma patients with soft tissue plasmacytoma, the presence of EM disease still contributed to a poor prognosis after ASCT compared to skeletal plasmacytoma, and these poor outcomes were not overcome by ASCT.

A phase IV, randomized, multicenter, open-label trial comparing efficacy and systemic exposure for a standard weight-based dose versus a fixed dose of plerixafor in combination with G-CSF in patients with Non-Hodgkin’s lymphoma weighing ≤70 kg

A randomized, multicenter, open-label study explored the effect of a fixed-dose (FD) of plerixafor versus the approved weight-based (WB) dose for the mobilization of hematopoietic stem cells (HSCs) in patients with non-Hodgkin’s lymphoma and a body weight of ≤70u2009kg. After mobilization with granulocyte colony-stimulating factor (G-CSF) 10u2009μg/kg/day for 4 days, patients were randomized 1:1 to either plerixafor FD 20u2009mg (nu2009=u200930) or WB 0.24u2009mg/kg (nu2009=u200931) on the evening of Day 4. Co-primary endpoints were the proportion of patients achieving ≥5u2009×u2009106 CD34+ cells/kg in ≤4 days of apheresis, and total systemic exposure to plerixafor (area under the concentration–time curve from 0 to 10u2009h [AUC0–10]). There was no statistically significant difference between the proportion of patients attaining the primary efficacy endpoint (60% FD arm, 55% WB arm; Pu2009=u20090.395). Exposure to plerixafor was greater in the FD arm relative to the WB arm; however, there was no appreciable difference regarding fold increases of peripheral blood CD34+ cells. The safety profile was similar between treatment groups. These results suggest there is no statistically significant difference in HSC mobilization with a standard WB dosing regimen of plerixafor plus G-CSF in patients with low body weight compared with an FD regimen.