Consensus Recommendations for the Clinical Management of Patients with Multiple Myeloma Treated with Selinexor

Abstract Multiple myeloma patients have seen an unprecedented improved survival in the last decade, primarily due to the introduction of three novel classes of anti-myeloma drugs (proteasome inhibitors, immunomodulatory agents and monoclonal antibodies) and the appropriate use of autologous stem cell transplant. Despite these advances, myeloma remains an incurable disease that behaves more aggressively with each subsequent relapse, and in majority of patients at some point in their disease course are left with exhaustion of all the existing options. Selinexor is an oral and first-in-class nuclear export inhibitor approved by the United States Food and Drug Administration (FDA) in July 2019 for patients with relapsed and refractory myeloma that have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. The FDA approval of selinexor was based on the Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study with single agent activity with a 25.3% overall response rate (ORR) in heavily pretreated patients. As an oral agent, selinexor carries significant but predictable toxicity profile that can be appropriately managed with adequate supportive care, primarily anorexia, nausea and cytopenias. As a result, in the STORM trial 58% of patients required dose adjustments and 27% discontinued treatment due to adverse events. This consensus article was designed to assist providers in the practical administration of this anti-myeloma agent in clinical practice. The expert panel consists of physicians and nurse practitioners who participated in the clinical trials with selinexor.