ABSTRACT
Purpose: Multiple myeloma (MM) patients with triple- and penta-refractory disease have a poor survival and limited treatment options. Selinexor, in combination with bortezomib and dexamethasone, demonstrated clinical activity in the STOMP study as well as in the BOSTON study in previously treated patients with disease refractory to a proteasome inhibitor (PI). Patients and Methods: Here, we report a real-world case series of 7 heavily pretreated MM patients who had been extensively pretreated with bortezomib and had disease refractory to PIs, including carfilzomib; who were administered a starting dose of 100 mg of selinexor, 20-40 mg dexamethasone and 1.3 mg/m2 of bortezomib, each once weekly. The majority of these patients (6 patients, 86.0%) had penta-refractory disease, with 5 patients (71.4%) having disease refractory to bortezomib and carfilzomib, and all 7 patients having pomalidomide refractory disease. The median number of prior lines of therapy was 8 (range 4-12). Results: The seven patients in this case series received selinexor for a median of 5 cycles (range 1-10). Four patients (57.1%) had a dose reduction of selinexor. Five patients (71.4%) had a response, of which 2 (29.0%) had a very good partial response (VGPR) and 3 (43.0%) had a partial response (PR). One patient (14.3%) had stable disease (SD) and 1 (14.3%) had progressive disease (PD). There were no new safety signals. Conclusion: The selinexor, bortezomib, and dexamethasone triplet combination demonstrates activity in PI-resistant MM and patients with heavily pretreated MM with refractory disease and after multiple lines of therapy.
ABSTRACT
Objective: The aim of this study was to evaluate the administration of intravenous immunoglobulin (IVIg) solutions (5% vs. 10%) in hematological patients suffering from a secondary immunodeficiency (SID) to optimize infusion duration and hospitalization time. Design: A monocentric, observational study in 30 patients with secondary hypogammaglobulinemia due to a lymphoproliferative disorder currently under IVIg 5% treatment. A sequential approach was followed with observations during IVIg 5% and 10% administration 3 to 4 weeks later. Infusion time, time spent at the day clinic, IVIg-related adverse events and number of actions taken by the nursing staff were evaluated and compared between the 5% and 10% infusions. Questionnaires for patients and nursing staff were obtained after IVIg 10% to assess their satisfaction with the change of infusion. Results: Average infusion time was reduced from 4.92 h to 2.29 h (p < 0.0001). Time spent at the day clinic was 5.87 h for the 5% IVIg administration and 4.56 h for the 10% (p = 0.0005). IVIg-related adverse events rose from 0 to 0.43 per patient. No serious adverse events were reported. Nursing actions per patient decreased from 1.03 to 0.67. Patient and nursing satisfaction were respectively 83% and 96% in favor of IVIg 10%. Conclusion: A 10% IVIg solution can significantly reduce infusion time and overall duration of the day clinic visit. Care must be taken to minimize new infusion-related adverse events. Switching to a 10% IVIg administration increases patient and nursing satisfaction but also requires additional workflow changes to further shorten the day clinic visit.
