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STUDY PROTOCOL article

Front. Hematol.
Sec. Blood Cancer
Volume 3 - 2024 | doi: 10.3389/frhem.2024.1436845

Comparison of 6 cycles of isatuximab with lenalidomide, bortezomib and dexamethasone (I-VRd) versus 3 cycles of I-VRd followed by one cycle of high-dose melphalan in newly diagnosed low-risk multiple myeloma. Protocol for a multicenter, prospective, randomized, phase II clinical trial (ELIAS-Trial)

Provisionally accepted
Theo Leitner Theo Leitner 1*Evgenii Shumilov Evgenii Shumilov 2Christina Schwitlick Christina Schwitlick 1Raphael Koch Raphael Koch 3Franziska Hamm Franziska Hamm 1Marion Högner Marion Högner 4Florian Bassermann Florian Bassermann 4Katja Weisel Katja Weisel 5Hermann Einsele Hermann Einsele 6Leo Rasche Leo Rasche 6Martin Görner Martin Görner 7Kai Wegehenkel Kai Wegehenkel 7Stefan Knop Stefan Knop 8Jan Kroenke Jan Kroenke 9Axel Nogai Axel Nogai 9Inke R. König Inke R. König 10Maren Vens Maren Vens 10Kay Horn Kay Horn 11Nikolas C. von Bubnoff Nikolas C. von Bubnoff 1Cyrus Khandanpour Cyrus Khandanpour 1*
  • 1 Department of Hematology and Oncology, University Medical Center Schleswig-Holstein (UKSH) and University Cancer Center Schleswig-Holstein (UCCSH), Lübeck, Germany
  • 2 Department of Medicine A, Hematology, Oncology and Pneumology, University Hospital Münster, Münster, Germany
  • 3 Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany
  • 4 Department of Internal Medicine III, University Hospital rechts der Isar, Technical University of Munich, Munich, Bavaria, Germany
  • 5 Department of Hematology, Oncology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  • 6 Department of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany
  • 7 Department of Hematology, Oncology and Palliative Care, Klinikum Bielefeld Mitte, Bielefeld, Germany
  • 8 Internal Medicine Center 5, Department of Oncology/Hematology, Paracelsus Medical Private University, Clinic Nürnberg Nord, Nürnberg, Germany
  • 9 Department of Hematology, Oncology and Cancer Immunology, Charité-Universitätsmedizin Berlin, Berlin, Germany
  • 10 Institute for Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany
  • 11 Center for Clinical Trials, University of Lübeck, Lübeck, Germany

The final, formatted version of the article will be published soon.

    in a non-inferior rate of complete remission (CR) combined with MRD-negativity at week 40 after the start of induction therapy compared to three cycles of I-VRd followed by standard of care treatment (such as stem cell apheresis, high-dose melphalan, and autologous stem cell transplantation). We hypothesize that this approach could reduce toxicity, cost of treatment and the likelihood of the development of a more malignant plasma cell clone, while improving overall survival (OS) and progression-free survival (PFS) in newly diagnosed low risk myeloma patients.

    Keywords: Newly diagnosed multiple myeloma, Clinical Trial, High-dose melphalan, autologous stem cell transfusion, isatuximab, MRD, personalized therapy

    Received: 28 May 2024; Accepted: 20 Aug 2024.

    Copyright: © 2024 Leitner, Shumilov, Schwitlick, Koch, Hamm, Högner, Bassermann, Weisel, Einsele, Rasche, Görner, Wegehenkel, Knop, Kroenke, Nogai, König, Vens, Horn, von Bubnoff and Khandanpour. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Theo Leitner, Department of Hematology and Oncology, University Medical Center Schleswig-Holstein (UKSH) and University Cancer Center Schleswig-Holstein (UCCSH), Lübeck, Germany
    Cyrus Khandanpour, Department of Hematology and Oncology, University Medical Center Schleswig-Holstein (UKSH) and University Cancer Center Schleswig-Holstein (UCCSH), Lübeck, Germany

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.