An oral proteasome inhibitor used in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma following progression on at least 1 prior therapy.
The efficacy of the drug was shown in the 722-patient phase 3 TOURMALINE-MM1 trial comparing treatment with ixazomib plus lenalidomide and dexamethasone versus 14.7 months with lenalidomide and dexamethasone alone.
Patients were administered 25 mg of oral lenalidomide on days 1-21 and 40 mg of oral dexamethasone on days 1, 8, 15, and 22 in combination with ixazomib at 4 mg on days 1, 8, and 15, or placebo.
The results showed a median progression-free survival (PFS) of 20.6 months with ixazomib plus lenalidomide and dexamethasone compared with 14.7 months with lenalidomide and dexamethasone alone.
The addition of ixazomib did not cause a substantial increase in adverse events.
The TOURMALINE-MM3 clinical trial demonstrated a 28% reduction in risk for progression or death, corresponding to a 39% improvement in progression-free survival with ixazomib maintenance therapy in patients with newly diagnosed multiple myeloma after ABMT.
Most common side effects are diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting, and back pain.
The drug is administered orally, once weekly on days one, eight, and 15 of the 28 day treatment cycle.
Dosages 4,3 and 2.3 mg.
With renal or hepatic disease dose is decreased to 3 mg dose.