Ixazomib

In a prospective randomized trial involving 722 patients with relapsed or refractory myeloma, ixazomib combined with lenalidomide and dexamethasone was compared with a placebo combined with lenalidomide and dexamethasone.[33,34]

In a prospective randomized trial involving 722 patients with relapsed or refractory myeloma, ixazomib combined with lenalidomide and dexamethasone was compared with a placebo combined with lenalidomide and dexamethasone.[33,34]

With a median follow-up of 2 years, the median PFS was 20.6 months in the ixazomib group versus 14.7 months for the placebo group (HR, 0.66; 95% CI, 0.47–0.93; P = .016).[33][Level of evidence B1]

In a prospective randomized trial involving 722 patients with relapsed or refractory myeloma, ixazomib combined with lenalidomide and dexamethasone was compared with a placebo combined with lenalidomide and dexamethasone.[33,34]

Improved PFS was also seen for high-risk patients (defined by fluorescence in situ hybridization and cytogenetics).[34][Level of evidence B1]

In a prospective randomized trial involving 722 patients with relapsed or refractory myeloma, ixazomib combined with lenalidomide and dexamethasone was compared with a placebo combined with lenalidomide and dexamethasone.[33,34]

No grade 3 or 4 neuropathy was seen in any patient treated with ixazomib.

In a prospective randomized trial involving 722 patients with relapsed or refractory myeloma, ixazomib combined with lenalidomide and dexamethasone was compared with a placebo combined with lenalidomide and dexamethasone.[33,34]

With a median follow-up of 85 months, there was little difference in the median OS at 53.6 months for the ixazomib group and 51.6 months for the placebo group (HR, 0.939; P = .49).[35][Level of evidence B1 based on PFS, as noted above]

A prospective randomized trial (NCT01850524) included 705 patients with newly diagnosed, transplant-eligible multiple myeloma. The study compared ixazomib combined with lenalidomide and dexamethasone with a placebo combined with lenalidomide and dexamethasone.[36]

A prospective randomized trial (NCT01850524) included 705 patients with newly diagnosed, transplant-eligible multiple myeloma. The study compared ixazomib combined with lenalidomide and dexamethasone with a placebo combined with lenalidomide and dexamethasone.[36]

With a median follow-up of 53.3 to 55.8 months for each arm, the median PFS was 35.3 months in the ixazomib group versus 21.8 months in the placebo group (HR, 0.830; 95% CI, 0.676–1.018; P = .073).[36][Level of evidence B1] This difference did not meet statistical significance for PFS.

A prospective randomized trial of patients with relapsed myeloma undergoing a second autologous SCT compared consolidation and maintenance therapy with ixazomib versus observation alone.[37]

A prospective randomized trial of patients with relapsed myeloma undergoing a second autologous SCT compared consolidation and maintenance therapy with ixazomib versus observation alone.[37]

With a median follow-up of 27 months, the median PFS was 20 months in the consolidation and maintenance therapy group and 13 months in the observation group (HR, 0.55; 95% CI, 0.39–0.78; P = .0006).[37][Level of evidence B1]