PLoS ONE (Jan 2021)

The real-world outcomes of multiple myeloma patients treated with daratumumab.

  • Agoston Gyula Szabo,
  • Tobias Wirenfeldt Klausen,
  • Mette Bøegh Levring,
  • Birgitte Preiss,
  • Carsten Helleberg,
  • Marie Fredslund Breinholt,
  • Emil Hermansen,
  • Lise Mette Rahbek Gjerdrum,
  • Søren Thorgaard Bønløkke,
  • Katrine Nielsen,
  • Eigil Kjeldsen,
  • Katrine Fladeland Iversen,
  • Elena Manuela Teodorescu,
  • Marveh Dokhi,
  • Eva Kurt,
  • Casper Strandholdt,
  • Mette Klarskov Andersen,
  • Annette Juul Vangsted

DOI
https://doi.org/10.1371/journal.pone.0258487
Journal volume & issue
Vol. 16, no. 10
p. e0258487

Abstract

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Most patients cannot be included in randomized clinical trials. We report real-world outcomes of all Danish patients with multiple myeloma (MM) treated with daratumumab-based regimens until 1 January 2019.MethodsInformation of 635 patients treated with daratumumab was collected retrospectively and included lines of therapy (LOT), hematologic responses according to the International Myeloma Working Group recommendations, time to next treatment (TNT) and the cause of discontinuation of treatment. Baseline characteristics were acquired from the validated Danish Multiple Myeloma Registry (DMMR).ResultsDaratumumab was administrated as monotherapy (Da-mono) in 27.7%, in combination with immunomodulatory drugs (Da-IMiD) in 57.3%, in combination with proteasome inhibitors (Da-PI) in 11.2% and in other combinations (Da-other) in 3.8% of patients. The median number of lines of therapy given before daratumumab was 5 for Da-mono, 3 for Da-IMiD, 4 for Da-PI, and 2 for Da-other. In Da-mono, overall response rate (ORR) was 44.9% and median time to next treatment (mTNT) was 4.9 months. In Da-IMiD, ORR was 80.5%, and mTNT was 16.1 months. In Da-PI, OOR was 60.6% and mTNT was 5.3 months. In patients treated with Da-other, OOR was 54,2% and mTNT was 5.6 months. The use of daratumumab in early LOT was associated with longer TNT (pConclusionThe real-world outcomes of multiple myeloma patients treated with daratumumab are worse than the results of clinical trials. Outcomes achieved with daratumumab were best when daratumumab was used in combination with IMIDs and in early LOT. Patients with high-risk CA had worse outcomes, but patients with amp1q had similar outcomes to standard-risk patients.