Selinexor is a novel, first-in-class, orally administered “Selective Inhibitor of Nuclear Export” (SINE™) compound. Selinexor blocks the ability of cancer cells to export tumor suppressor proteins from their cell nuclei. This restores the tumor suppressor proteins’ ability to detect cancerous DNA changes and induce cancer cell death. Selinexor also reduces levels of key proteins that promote cancer cell growth.
Selinexor STORM study
The STORM clinical trial of selinexor is for eligible patients who are “penta-refractory” to Velcade® (bortezomib), Kyprolis® (carfilzomib), Revlimid® (lenalidomide), Pomalyst® (pomalidomide), and Darzalex® (daratumumab). This trial is for heavily pretreated myeloma patients with relapsed, refractory disease. Patients must have disease that progressed during, or within 60 days after completing therapy with steroids (dexamethasone, prednisone, or methylprednisolone), an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
STORM study participants will receive treatment with selinexor plus dexamethasone until their myeloma progresses or until they are unable to tolerate the regimen. Patients may decide not to participate and withdraw their consent at any time, for any reason. STORM is currently enrolling patients at more than 20 US sites. In the coming months, the STORM study will be opening in additional US sites and also in Europe. For the most up-to-date information on the STORM study, please visit ClinicalTrials.gov and enter identifier NCT02336815 in the search box.
Selinexor BOSTON study
The objective of the BOSTON clinical trial is to compare the effectiveness and safety of selinexor + Velcade + low-dose dexamethasone (SVd) to Velcade + low-dose dexamethasone (Vd) , and to compare the health-related quality of life of patients receiving each regimen. Approximately 364 myeloma patients who have been treated with 1 to 3 prior anti-myeloma regimens and have disease that has progressed during or within 60 days after prior treatment will be randomly assigned by a computer to receive either SVd or Vd. Trial participants will know whether they are receiving SVd or Vd. Patients in the Vd arm of the study whose disease progression is confirmed by an independent review committee may cross over to receive SVd treatment.
This trial is currently enrolling participants at four sites in Canada and one site in Greece. New sites will be opening in the coming weeks and months. Please check current site status by visiting the clinicaltrials.gov website and using trial identifier NCT03110562 in the search box.
“Early clinical results with Selinexor are encouraging, even in patients who have been treated with all available myeloma drugs. The STORM and BOSTON trials will help define in larger populations of patients the effectiveness of Selinexor and will determine whether or not this drug should move towards regulatory approval.”
Keith Steward, MD
“The STORM trial represents an important opportunity for patients with myeloma who have been treated with all available agents and still have disease. This is a very important trial for heavily pretreated myeloma patients based on the phase II data indicating that up to 30% of patients may have responses to Selinexor and dexamethasone.”
Raymond L. Comenzo, MD
Tufts University School of Medicine