Skip to main content

BRIEF RESEARCH REPORT article

Front. Hematol.
Sec. Blood Cancer
Volume 3 - 2024 | doi: 10.3389/frhem.2024.1335161

First clinical Experience of Isatuximab Safety and Tolerability in relapsed and refractory Multiple Myeloma (RRMM): Real-world Data from a Compassionate Use Program in Germany

Provisionally accepted
Theo Leitner Theo Leitner 1*Cyrus Khandanpour Cyrus Khandanpour 1*Knut Wendelin Knut Wendelin 2Fuat Oduncu Fuat Oduncu 3Christoph Kimmich Christoph Kimmich 4Ralph Naumann Ralph Naumann 5Miriam Kull Miriam Kull 6Hartmut Goldschmidt Hartmut Goldschmidt 7Martin Ehmer Martin Ehmer 8Claudia Kiewitz Claudia Kiewitz 8Hans Salwender Hans Salwender 9*
  • 1 Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Hämatologie und Onkologie, Lübeck, Germany
  • 2 Internal Medicine Center 5, Department of Oncology/Hematology, Paracelsus Medical Private University, Clinic Nürnberg Nord, Nürnberg, Germany
  • 3 Klinik für Hämatologie, Onkologie und Palliativmedizin, Helios Klinikum München West, München, Germany
  • 4 Universitätsklinik für Innere Medizin – Onkologie und Hämatologie, Klinikum Oldenburg, Oldenburg, Lower Saxony, Germany
  • 5 Klinik für Hämatologie, Medizinische Onkologie und Palliativmedizin Marien Kliniken Siegen, Siegen, North Rhine-Westphalia, Germany
  • 6 Klinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany
  • 7 Klinik für Hämatologie, Onkologie und Rheumatologie, Universitätsklinikum Heidelberg, Heidelberg, Baden-Württemberg, Germany
  • 8 Sanofi (Germany), Frankfurt, Hesse, Germany
  • 9 Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg, Hamburg, Germany

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

    Therapy of relapsed and refractory multiple myeloma (RRMM) remains challenging. Monoclonal antibodies against CD38 combined with pomalidomide have proven efficacy in clinical trials, but realworld data is sparse. We present real-world data of a compassionate use program (CUP) of isatuximab given in combination with pomalidomide and dexamethasone according to the German Compassionate Use Directive ahead of commercial availability for adult patients with RRMM. Patients had received at least two prior lines of therapy including lenalidomide and a proteosome inhibitor and have demonstrated disease progression on the last therapy. Isatuximab was administered within the clinical routine. In total, 18 patients were included into the CUP before official market availability of isatuximab. The data reflect a heterogenous population, regarding age, risk-factors, previous diseases, and treatments. Most of the patients had received 2 full isatuximab cycles. The analysis showed no new safety signals, supporting a manageable toxicity profile of isatuximab highlighting the manageable toxicity profile of isatuximab in the real-world setting. * discontinuation due to death; # discontinuation due to progression + discontinuation due to other reasons.

    Keywords: isatuximab, Multiple Myeloma, Relapsed/refractory, Real-world, Compassionate Use

    Received: 08 Nov 2023; Accepted: 30 Apr 2024.

    Copyright: © 2024 Leitner, Khandanpour, Wendelin, Oduncu, Kimmich, Naumann, Kull, Goldschmidt, Ehmer, Kiewitz and Salwender. 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, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Hämatologie und Onkologie, Lübeck, Germany
    Cyrus Khandanpour, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Hämatologie und Onkologie, Lübeck, Germany
    Hans Salwender, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg, 22763, Hamburg, 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.