Multiple myeloma: early levofloxacin prophylaxis reduces febrile episodes, deaths

  • Drayson MT, et al.
  • Lancet Oncol
  • 23 Oct 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In patients with multiple myeloma (MM), the addition of levofloxacin prophylaxis to MM treatment for the first 12 weeks following diagnosis was associated with a reduction in febrile episodes and deaths.

Why this matters

  • Infection contributes to death in one-fifth of MM patients; risk of infection is highest within the first 3 months of diagnosis.

Study design

  • Phase 3 study to investigate the benefit of 12 weeks of levofloxacin prophylaxis (n=489) vs placebo (n=488) in patients with newly diagnosed MM.
  • Median patient age:
    • Levofloxacin arm: 67 (range, 59-75) years.
    • Placebo arm: 67 (range, 61-75) years.
  • Funding: National Institute for Health Research (NIHR).

Key results

  • At 12 (interquartile range, 8-13) months median follow-up:
    • 19% experienced first febrile episode or death with levofloxacin in the first 12 weeks vs 27% with placebo: HR for time to first event within 12 weeks, 0.66 (95% CI, 0.51-0.86; P=.0018).
  • In the first 16 weeks of treatment:
    • 9% of 308 serious adverse events (SAEs) in the levofloxacin arm and 5% of 289 SAEs in the placebo arm were deemed possibly related to study drug.

Limitations

  • Relatively fit study population.