ASH 2021 | Phase III trial of RVd induction with or without isatuximab in newly diagnosed myeloma

Lenalidomide plus bortezomib and dexamethasone (RVd) is a widely used standard of care regimen for the treatment of patients with newly diagnosed multiple myeloma. To investigate the benefit of adding isatuximab (isa) to the RVd triplet induction regimen, a Phase III randomized, multicenter trial was conducted comparing the use of RVd with or without isa, based on the rate of measurable residual disease (MRD) negativity achieved. Hartmut Goldschmidt, MD, University Hospital Heidelberg, Heidelberg, Germany, presents the findings of the GMMG HD7 trial (NCT03617731) from over 600 patients with newly-diagnosed myeloma. Baseline characteristics were well balanced between the two treatment arms. MRD-negativity, assessed by next-generation flow, was achieved in 35.6% of patients treated with RVd compared to 50.1% who received isa-RVd (p less than 0.001). Treatment with Isa-RVd was a significant predictor for increased MRD negativity in multivariate analyses. Complete response (CR) rates were comparable across both treatment arms, but the proportion of patients reaching a very good partial response or better was significantly higher in those treated with Isa-RVd compared to RVd only. Furthermore, rates of serious adverse events were similar in both patient groups. Investigations are ongoing, including the analysis of a second randomization to receive lenalidomide maintenance with or without the addition of isa after autologous transplantation. This press briefing was recorded at the American Society of Hematology (ASH) 2021 Annual Meeting and Exposition in Atlanta, GA.