Adding selinexor to Vd regimen for older or more frail patients with multiple myeloma.

The aim of this study was to evaluate the safety and effectiveness of adding selinexor (X; Xpovio) to the Vd (bortezomib and dexamethasone) regimen in older, frail patients with multiple myeloma (MM). The study found that the addition of selinexor to Vd (XVd) was safe and gave older, more frail patients a better outcome.

MM is a type of blood cancer. Therapy for MM can include targeted therapy (TT), immunotherapy (IT), and chemotherapy (CT). Combining these treatments at the high doses needed to treat MM can cause significant side effects in patients. Older or more frail patients are more likely to suffer these side effects. Sometimes these patients need to have a reduced dose of therapy which could impact how effective therapy is.

X has recently been approved in combination with Vd for the treatment of patients with previously treated MM. However, the safety and effectiveness of the XVd regimen in older/more frail patients are still unknown.

This study evaluated data from 402 patients with previously treated MM. 207 patients were given Vd twice a week. 195 patients were given XVd with dexamethasone at a lower dose once a week. Patients were divided into 4 groups. Group 1 had patients younger than 65 years, group 2 had those aged 65 and over, group 3 had non-frail patients and group 4 had frail patients. Each group had similar numbers of patients treated with either Vd or Xvd. Frailty was defined based on physical fitness and additional medical conditions.

XVd was associated with an improved survival without cancer worsening in both groups 1 and 2. Patients over 65 years who were treated with XVd were 77% more likely to respond to therapy, 45% more likely to survive without cancer worsening, and 37% more likely to have longer survival than those treated with Vd. 

Frail patients who were treated with XVd were 31% more likely to have longer survival without progression of the disease compared to Vd treatment. These patients were also 38% more likely to have a longer rate of survival than those treated with Vd.

Patients over 65 years and frail patients treated with XVd were significantly less likely to experience moderate to severe nerve damage compared to those treated with Vd. However, serious side effects occurred more frequently in the XVd group compared to Vd, in all subgroups.

The study found that the XVd regimen was safe and gave older, more frail patients with MM a better outcome.

This study was funded by Karyopharm Therapeutics who manufacture selinexor.