According to a new study published in the journal The Lancet Oncology, the combination of ixazomib plus lenalidomide and dexamethasone was well tolerated and demonstrated activity in patients with newly diagnosed multiple myeloma.
For the phase 1/2 study, the researchers sought to investigate the safety and effectiveness of ixazomib, a novel oral proteasome inhibitor, with lenalidomide and dexamethasone. Researchers enrolled 15 patients with newly diagnosed multiple myeloma to the phase 1 portion.
Those patients received escalating doses of ixazomib orally on days 1, 8, and 15, plus lenalidomide 25mg on days 1-21 and dexamethasone 40mg on days 1, 8, 15, and 22. Patients received up to 12 28-day cycles, following by treatment with ixazomib alone.
The recommended dose of ixazomib identified in phase 1 for phase 2 was 2.23mg/m2, which was converted to a 4.0mg fixed dose. In phase 2, researchers enrolled 50 participants and they received the same regimen as in phase 1 with ixazomib given at a dose of 4.0mg.
Results showed that grade 3 or higher adverse effects occurred in 63% of patients and five patients discontinued treatment due to adverse effects. Of the 64 response-evaluable patients, 58% (95% CI: 45 - 70) were said to have had a very good partial response or better.
In a phase 1/2 trial the authors aimed to assess the safety, tolerability, and activity of ixazomib in combination with lenalidomide and dexamethasone in newly diagnosed multiple myeloma. The all-oral combination of weekly ixazomib plus lenalidomide and dexamethasone was generally well tolerated and appeared active in newly diagnosed multiple myeloma.