DOI: 10.1200/jco-24-02266 ISSN: 0732-183X

Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma: Final Part 1 Analysis of the GMMG-HD7 Trial

Elias K. Mai, Uta Bertsch, Ema Pozek, Roland Fenk, Britta Besemer, Christine Hanoun, Roland Schroers, Ivana von Metzler, Mathias Hänel, Christoph Mann, Lisa B. Leypoldt, Bernhard Heilmeier, Stefanie Huhn, Sabine K. Vogel, Michael Hundemer, Christof Scheid, Igor W. Blau, Steffen Luntz, Niels Weinhold, Diana Tichy, Tobias A.W. Holderried, Karolin Trautmann-Grill, Deniz Gezer, Maika Klaiber-Hakimi, Martin Müller, Evgenii Shumilov, Wolfgang Knauf, Christian S. Michel, Thomas Geer, Hendrik Riesenberg, Christoph Lutz, Marc S. Raab, Axel Benner, Martin Hoffmann, Katja C. Weisel, Hans J. Salwender, Hartmut Goldschmidt, , Miriam Ahlborn, Joachim Behringer, Helga Bernhard, Britta Besemer, Jörg Bittenbring, Igor Wolfgang Blau, Claus Bolling, Amelie Boquoi, Daniel Debatin, Gerlinde Egerer, Roland Fenk, Barbara Ferstl, Stefan Fronhoffs, Tobias Gaska, Thomas Geer, Deniz Gezer, Hartmut Goldschmidt, Martin Görner, Ullrich Graeven, Mathias Hänel, Bernhard Heilmeier, Michael Heinsch, Martin Hoffmann, Tobias A.W. Holderried, Olaf Hopfer, Snjezana Janjetovic, Maika Klaiber-Hakimi, Martine Klausmann, Stefan Klein, Wolfgang Knauf, Yon-Dschun Ko, Doris Maria Kraemer, Martin Kropff, Paul La Rosée, Rolf Mahlberg, Christoph Mann, Uwe Martens, Ivana von Metzler, Christian Michel, Martin Müller, Wolfram Pönisch, Peter Reimer, Claudia Riechel, Mark Ringhoffer, Mathias Rummel, Volker Runde, Hans Jürgen Salwender, Markus Schaich, Christoph Scheid, Martin Schmidt-Hieber, Daniel Schöndube, Roland Schroers, Hans-Joachim Schütte, Evgenii Shumilov, Peter Staib, Dirk Strumberg, Hans-Joachim Tischler, Karolin Trautmann-Grill, Walter Verbeek, Rudolf Weide, Eckhart Weidmann, Katja Weisel, Maike de Wit, Christiane Bernhardt, Thomas Fietz, Jochen Grassinger, Georg Köchling, Michael Neise, Stefan Schmitt, Heike Steiniger, Barbara Tschechne, Bettina Whitlock, Matthias Zaiß, Carsten Ziske
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Previously, addition of isatuximab (Isa) to standard-of-care lenalidomide-bortezomib-dexamethasone (RVd) in transplant-eligible patients with newly diagnosed multiple myeloma in the GMMG-HD7 trial (ClinicalTrials.gov identifier: NCT03617731 ) resulted in a significant increase of minimal residual disease negativity (MRD–) rates after induction therapy. A total of 662 patients were randomly assigned to receive induction therapy with Isa-RVd (n = 331) or RVd (n = 329), followed by single or tandem autologous stem-cell transplant and second random assignment to maintenance with lenalidomide alone or Isa-lenalidomide. We report updated results for part 1 from first random assignment to post-transplant. As of January 31, 2024, MRD– rates continued to deepen after transplant (66% Isa-RVd v 48% RVd). Isa-RVd induction therapy significantly prolonged progression-free survival (PFS) compared with RVd regardless of maintenance therapy (hazard ratio, 0.70 [95% CI, 0.52 to 0.95]; P = .0184). Weighted risk set estimator analysis accounting for second random assignment followed by maintenance with only lenalidomide confirmed a statistically significant benefit for Isa-RVd followed by lenalidomide maintenance versus RVd followed by lenalidomide maintenance (stratified weighted log-rank test P = .016). In conclusion, after 18-week induction therapy followed by transplant without consolidation therapy, adding Isa to RVd resulted in a significant PFS benefit, regardless of maintenance strategy.

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