Elderly non-transplant eligible newly diagnosed multiple myeloma (nte-NDMM) patients also benefit from novel therapies, however, overall survival (OS) is inferior in unfit and frail compared to fit patients as defined by the International Myeloma Working Group (IMWG) frailty index. This is caused by a high discontinuation rate due to toxicity. Therefore, a less toxic effective treatment for unfit and frail patients is needed. In view of the favorable safety profile of ixazomib (Ixa) and daratumumab (Dara), we investigated the efficacy and feasibility of treatment with Ixa and Dara plus low dose dexamethasone (Ixa-Dara-dex) in unfit and frail patients. This trial was registered at www.trialregister.nl as NTR6297.
Ixa-Dara-dex is an effective therapeutic regimen in unfit patients with limited toxicity, not giving rise to (early) mortality. Additionally, in the majority of frail patients this regimen is active and feasible. However, better identification and support of those patients is warranted, as we observed early mortality due to vulnerability and infections.