Efficacy of daratumumab monotherapy in real-world heavily pretreated patients with relapsed or refractory multiple myeloma

Adv Med Sci. 2019 Sep;64(2):349-355. doi: 10.1016/j.advms.2019.05.001. Epub 2019 May 21.

Abstract

Purpose: Daratumumab is a promising new agent for relapsed/refractory multiple myeloma (RRMM). However, there are limited data on its clinical activity and tolerability in the real-world patients. The purpose of this study is to determine the efficacy and toxicity profile of daratumumab monotherapy in the real-life setting.

Patients and methods: Thirty RRMM patients treated with daratumumab who had previously received at least three treatment lines including a proteasome inhibitor and an immunomodulatory drug or had been double refractory (DRMM) were included to the Polish Myeloma Group observational study.

Results: The objective response rate to daratumumab was 42.8%. Median progression-free survival (PFS) and overall survival reached 9.5 and 13.8 months, respectively. Importantly, patients with DR-MM had a significantly shorter PFS than other patients (median PFS of 4.1 vs. 12.1 months). Daratumumab was generally well tolerated, however two patients had their therapy interrupted due to adverse events.

Conclusion: Daratumumab monotherapy has significant activity and good tolerance in heavily pretreated RRMM patients.

Keywords: CD38; Daratumumab; Immunotherapy; Multiple myeloma; Relapsed.

MeSH terms

  • ADP-ribosyl Cyclase 1
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal / therapeutic use*
  • Antineoplastic Agents / therapeutic use*
  • Disease-Free Survival
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Immunotherapy / methods
  • Male
  • Middle Aged
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / pathology
  • Multiple Myeloma / therapy*
  • Neoplasm Recurrence, Local
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal
  • Antineoplastic Agents
  • daratumumab
  • ADP-ribosyl Cyclase 1