• Annals of hematology · Jun 2019

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

    • 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, Patrick Thomaré, Le Gouill Steven S Service d'hématologie Clinique, Centre Hospitalier Universitaire, Nantes, France. CRC, Philippe Moreau, and Cyrille Touzeau.
    • Service d'hématologie Clinique, Centre Hospitalier Universitaire, Nantes, France.
    • Ann. Hematol. 2019 Jun 1; 98 (6): 1435-1440.

    AbstractThe 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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