- 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.
- 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).
- 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.
- Relatively fit study population.