Haupt Pharma Amareg GmbH

To determine the effectiveness of maintenance therapy with ixazomib compared with placebo in patients with NDMM who had a significant response (complete response [CR], very good partial response [VGPR], or partial response [PR]) after initial treatment and who were not SCT. Impact on progression-free survival (PFS), defined as the time from randomization to progression of disease (PD) or death from any cause.

The primary objective was to determine whether the addition of dexamethasone to ixazomib citrate capsules (formerly known as MLN9708 capsules; Ixazomib capsules) can improve hematologic remission (PR+VGPR+CR) in patients with relapsed or refractory systemic light-chain (AL) amyloidosis, and whether it can improve the 2-year rate of major organ (ie, heart or kidney) deterioration and patient mortality in patients with relapsed or refractory AL amyloidosis, compared with chemotherapy selected by the physician from a list of treatment options.

Primary objective: To determine the efficacy of ixazomib maintenance therapy versus placebo in patients with NDMM who have a significant response (complete response [CR], very good partial response [VGPR], or partial response [PR]) after initial treatment and who are SCT-naive. Compared with the effect on PFS (defined as the time from randomization to the development of PD or death from any cause).