Moffitt Cancer Center Researchers Present Phase 1 Study Results of Selinexor Combination Therapy for Multiple Myeloma Patients

June 06, 2016

TAMPA, Fla. – Moffitt Cancer Center will present results from a phase 1 study of selinexor in combination with liposomal doxorubicin and dexamethasone in patients with relapsed and refractory multiple myeloma. The findings will be discussed Monday, June 6, during the American Society of Clinical Oncology Annual Meeting in Chicago. 

Selinexor is the first drug in a new class of agents known as Selective Inhibitor of Nuclear Export compounds. It works by inhibiting a protein found in the nucleus of cancer cells, activating tumor suppressors that kill the cancer cells. Normal cells are mostly spared. Preclinical studies have shown that selinexor is synergistic in combination with doxorubicin in mouse models of multiple myeloma. 

The goals of the phase 1 trial are to determine the maximum tolerated dose and the recommended phase 2 dose for selinexor, liposomal doxorubicin and dexamethasone in patients with relapsed and refractory multiple myeloma who received two or more prior therapies including lenalidomide and a proteasome inhibitor. In addition to the induction phase, treatment includes a loading phase and a maintenance phase both consisting of selinexor and dexamethasone only. 

When the abstract was submitted, 11 patients with a median of five prior lines of therapy were enrolled in the study. 

Dose limiting toxicities included low platelet counts, nausea, and low sodium levels. The most common adverse events possibly related to treatment were hyponatremia (54%), anemia (38%), thrombocytopenia (38%), neutropenia (38%), diarrhea (23%), vomiting (23%), hyperglycemia (15%) and fatigue (15%).  

Preliminary results suggest that the selinexor combination regimen is active in relapsed and refractory multiple myeloma. Of 10 evaluable patients, two each achieved a very good partial response, a partial response, and a minimal response. The remaining four had no response. 

Rachid Baz, M.D., associate member of the Malignant Hematology Department at Moffitt, will present the study results on Monday, June 6, during the 8 a.m. hematologic malignancies poster in Hall A of McCormick Place, and again during the 3 p.m. poster discussion session in room E354b. 

About Moffitt Cancer Center
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. One of the three largest cancer centers in the United States based on patient volume, the Tampa-based facility is one of only 45 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in Florida and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. Moffitt devotes more than 2 million square feet to research and patient care. With more than 5,000 team members, Moffitt has an economic impact in the state of $1.9 billion. For more information, call 1-888-MOFFITT (1-888-663-3488), visit MOFFITT.org, and follow the Moffitt momentum on Facebook, Twitter and YouTube.

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Media Contact at ASCO:
For more information, contact:
Kim Polacek
813-507-3173
Kim.Polacek@Moffitt.org