Isatuximab, Lenalidomide, Bortezomib, and Dex for Newly-Diagnosed Multiple Myeloma: GMMG-HD7

Abstract Title:
Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone for Newly-Diagnosed, Transplant-Eligible Multiple Myeloma: Interim Analysis of the GMMG-HD7 Trial
Summary:
The GMMG-HD7 trial evaluated the efficacy of adding isatuximab (Isa) to standard-of-care induction therapy followed by high-dose therapy (HDT) and autologous stem cell transplantation (ASCT) in transplant-eligible patients with newly-diagnosed multiple myeloma (NDMM). The interim analysis showed that patients who received Isa-RVd achieved deeper responses and higher rates of minimal residual disease (MRD) negativity compared to those who received RVd. The addition of isatuximab resulted in significantly higher rates of very good partial response (VGPR) or better and complete response (CR) or better. Furthermore, more patients achieved MRD negativity after last ASCT in the Isa-RVd arm. These findings suggest that isatuximab may be a valuable addition to the treatment approach for transplant-eligible NDMM patients. The trial is ongoing and will further evaluate the addition of isatuximab to lenalidomide maintenance treatment.
Key Points:
• Anti-CD38 monoclonal antibodies, such as isatuximab, have been shown to increase efficacy when added to standard-of-care regimens in multiple myeloma.
• The GMMG-HD7 trial included transplant-eligible patients with newly-diagnosed multiple myeloma at 67 sites in Germany.
• Patients were randomized to receive three cycles of either Isa-RVd or RVd induction therapy.
• After induction therapy, patients underwent stem cell collection and proceeded to HDT with melphalan and ASCT.
• Maintenance treatment with lenalidomide alone or in combination with Isa was given for up to 36 months.
• MRD was assessed using next-generation flow cytometry with a sensitivity of 10-5.
• The interim analysis showed that patients who received Isa-RVd achieved deeper responses and higher rates of MRD negativity compared to those who received RVd.
• The rates of very good partial response (VGPR) or better and complete response (CR) or better were significantly higher in the Isa-RVd arm.
• More patients achieved MRD negativity after last ASCT in the Isa-RVd arm compared to the RVd arm.
• Subgroup analyses will be presented to provide more detailed information.
• Among patients who remained on study per protocol, the rates of MRD negativity at the end of intensification were higher in the Isa-RVd arm compared to the RVd arm.
• The status of MRD negativity after induction was confirmed in a high percentage of patients after intensification.
• Only a small number of patients lost their MRD negative status, while a significant number of patients converted from MRD positive after induction to MRD negative after intensification.
• The addition of isatuximab to standard-of-care induction followed by HDT and ASCT resulted in a significantly higher rate of deep responses and MRD negativity rates in every treatment phase.
• The trial is ongoing and will evaluate the addition of Isa to lenalidomide maintenance treatment following second randomization.
Authors:
Marc S. Raab, Elias K Mai, Uta Bertsch, roland fenk, Ema Pozeck, Axel Benner, Britta Besemer, Christine Hanoun, Roland Schroers, Ivana von Metzler, Mathias Hänel, Christoph Mann, Lisa Leypoldt, Bernhard Heilmeier, Sabine Vogel, Stefanie Huhn, Michael Hundemer, Selina Hutzl, Niels Weinhold, Tobias Holderried, Karolin Trautmann-Grill, Deniz Nogueira Gezer, Maika Klaiber, Martin Müller, Evgenii Shumilov, Wolfgang Knauf, Christian Michel, Thomas Geer, Hendrik Riesenberg, Christoph Lutz, Martin Hoffmann, Hans Salwender, Katja Weisel, Hartmut Goldschmidt
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