New data from a phase III clinical trial may indicate that a drug used in combination therapy for multiple myeloma may be effective as a single-agent therapy.
The drug is Ninlaro (ixazomib) is an oral proteasome inhibitor currently approved by the U.S. Food and Drug Administration (FDA) as part of a combination therapy (with lenalidomide and dexamethasone) for treating patients with multiple myeloma who have received at least one prior therapy.
In the phase III trial, 706 adults were given either ixazomib [3 mg capsule on days 1, 8 and 15 in a 28-day cycle for Cycles 1 through 4 followed by ixazomib (3 or 4 mg) for Cycles 5 through 26] or placebo as maintenance therapy following successful completion of their initial chemotherapy to treat multiple myeloma.
The study reached its primary endpoint of progression free survival (PFS). No further details are available at this time but the data is expected to be presented at an upcoming meeting.
Multiple myeloma is a hematologic malignancy. It is characterized by the expansion of malignant plasma cells in the bone marrow associated with excessive production of monoclonal immunoglobulins in blood and urine. Individuals with multiple myeloma develop significant osteolytic bone lesions and have immunodeficiency that compromise their longevity and quality of life. Over the past couple of decades, there has been an explosion of research examining the pathophysiology of multiple myeloma and it is becoming clear that multiple myeloma cells are highly dependent on the variety of bone marrow cells that surround them.
Multiple myeloma remains an incurable condition but with the advances made in targeted therapies such as ixazomib, it is hoped that individuals can manage this chronic condition and continue to live a long, productive life.