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Single-agent daratumumab in very advanced relapsed and refractory multiple myeloma patients: a real-life single-center retrospective study

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Abstract

The anti-CD38 monoclonal antibody daratumumab is approved as a single agent for the treatment of patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMID), or who are double refractory to a PI and an IMID. To date, no real-life data on the efficacy and tolerance of daratumumab in this setting are available. We report here the results of a single-center series of 41 RRMM patients treated with single-agent daratumumab outside clinical trials. Patients received a median number of 4 prior therapies. All patients were previously exposed to PI and IMID and all patients were refractory to the last line of therapy. Most patients presented with high-risk characteristics, including 24% adverse cytogenetics (del17p/t(4,14)), 31% extramedullary disease and 12% circulating plasmacytosis at time of daratumumab therapy. The overall response rate was 24%, including 5% very good partial response or better. After a median follow-up of 6.5 months, all patients experienced disease relapse. The median progression-free survival was 1.9 months. At the time of disease progression, 44% of patients did not receive subsequent therapy. The median overall survival was 6.5 months. No new safety signal was identified. These real-life results revealed modest efficacy of single-agent daratumumab in advanced patients with RRMM in comparison with data from clinical trials.

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Acknowledgments

CT, PM, and SLG are members of Site de Recherche Intégrée sur le Cancer (SIRIC) “ILIAD,” (INCA-DGOS-Inserm_12558).

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Authors and Affiliations

  1. Service d’hématologie Clinique, Centre Hospitalier Universitaire, Nantes, France

    Maxime Jullien, Sabrina Trudel, Benoit Tessoulin, Béatrice Mahé, Viviane Dubruille, Nicolas Blin, Thomas Gastinne, Antoine Bonnet, Anne Lok, Amandine Lebourgeois, Pierre Peterlin, Alice Garnier, Patrice Chevalier, Thierry Guillaume, Steven Le Gouill, Philippe Moreau & Cyrille Touzeau

  2. CRCINA, INSERM, CNRS, Université d’Angers, Université de Nantes, Nantes, France

    Benoit Tessoulin, Steven Le Gouill, Philippe Moreau & Cyrille Touzeau

  3. Pharmacie Clinique Oncologique, Centre Hospitalier Universitaire, Nantes, France

    Patrick Thomaré

  4. Site de Recherche Intégrée sur le Cancer (SIRIC) « ILIAD », Nantes, France

    Steven Le Gouill, Philippe Moreau & Cyrille Touzeau

Authors
  1. Maxime Jullien
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  2. Sabrina Trudel
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  3. Benoit Tessoulin
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  4. Béatrice Mahé
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  5. Viviane Dubruille
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  6. Nicolas Blin
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  7. Thomas Gastinne
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  8. Antoine Bonnet
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  9. Anne Lok
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  10. Amandine Lebourgeois
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  12. Alice Garnier
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  15. Patrick Thomaré
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  16. Steven Le Gouill
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  17. Philippe Moreau
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  18. Cyrille Touzeau
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Contributions

CT PM and MJ designed the study. MJ collected data. MJ performed statistical analysis. CT and MJ wrote the manuscript. All authors treated patients and critically reviewed the manuscript and gave final approval.

Corresponding author

Correspondence to Cyrille Touzeau.

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Conflict of interest

CT and PM are advisory board member and received honoraria from Janssen. Other authors have no conflict of interest to declare.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Jullien, M., Trudel, S., Tessoulin, B. et al. Single-agent daratumumab in very advanced relapsed and refractory multiple myeloma patients: a real-life single-center retrospective study. Ann Hematol 98, 1435–1440 (2019). https://doi.org/10.1007/s00277-019-03655-5

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  • DOI: https://doi.org/10.1007/s00277-019-03655-5

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