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Phase III GMMG-HD7 Trial: Isatuximab-Based Therapy for Newly Diagnosed Myeloma

By: Victoria Kuhr, BA
Posted: Friday, January 14, 2022

Hartmut Goldschmidt, MD, of University Hospital Heidelberg and National Center of Tumor Diseases, Germany, and colleagues reported no increased rates of serious adverse events or early treatment discontinuation in patients given the CD38-monoclonal antibody isatuximab plus lenalidomide, bortezomib, and dexamethasone (RVd) compared with RVd alone. In addition, the investigators reported improved measurable residual disease (MRD) negativity rates with the addition of isatuximab. These findings were presented at the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 463).

The phase III GMMG-HD7 trial included patients with transplant-eligible, newly diagnosed multiple myeloma at 67 sites in Germany between October 2018 and September 2020. Patients were equally randomly assigned to receive three 42-day cycles of RVd in both arms. Isatuximab was added to arm 1B alone (10 mg/kg). The study assessed the rate of MRD negativity by next-generation flow after induction therapy as well as the rates of complete response after induction therapy and safety.

Of the 658 patients who started induction therapy, 328 received RVd and 330 received RVd plus isatuximab. The MRD negativity rates after induction therapy were 35.6% and 50.1% with RVd versus isatuximab plus RVd, respectively. On multivariate analyses, treatment with isatuximab remained a significant predictor for increased rates of MRD negativity after induction therapy. The rate of very good partial response or better was significantly higher with the addition of isatuximab than without it (60.5% vs. 77.3%). The rate of progressive disease was higher without isatuximab than with it (4.0% vs. 1.5%).

At least one adverse event (grade ≥ 3) during induction therapy was reported in 61.3% of patients given RVd and 63.6% of patients given isatuximab plus RVd. The rate of serious adverse events during induction therapy was similar with RVd and isatuximab/RVd (36.3% vs. 34.8%; P = .75).

Disclosure: For full disclosures of the study authors, visit ash.confex.com/ash.


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