TEAMM: Tackling early morbidity and mortality in myeloma

• Research type

  Research Study

• Full title

  Tackling Early Morbidity and Mortality in myeloma: assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections

• IRAS ID

  67602

• Contact name

  Mark Trehane Drayson

• Sponsor organisation

  University of Birmingham

• Eudract number

  2011-000366-35

• ISRCTN Number

  .

• Clinicaltrials.gov Identifier

  .

• Research summary

  Myeloma is a cancer of the bone marrow plasma cells and causes profound immunodeficiency in its early stages. A quarter of patients will have a serious infection within 3 months of diagnosis. Ten percent of patients die within the first 60 days of diagnosis, with bacterial infection directly causing 45% of these deaths. Preventative antibiotics are likely to be the single most effective measure to prevent early death in myeloma. Although the benefits of antibiotic prophylaxis are well established, there is concern that clinicians are withholding it because of fears of Healthcare Associated Infections (HCAI). TEAMM is looking at whether taking preventative antibiotics (levofloxacin) will decrease the number of infections that affect patients with early stage myeloma. It will also look at whether use of preventative antibiotics has an effect on carriage of and invasive infections by HCAIs. The study will start in September 2011, recruiting 800 patients from early 2012 for 4 years and will finish in August 2016. Patients will undergo standard anti-myeloma treatment and will be randomly allocated to 12 weeks of once daily oral levofloxacin or a placebo (allocation will be blinded to both patients and clinicians to avoid biasing the results). At entry and at 4 subsequent routine 4 weekly outpatient visits participants will have additional Blood, Stool and Nasal samples to assess their immune system and carriage of certain bacteria. They will also keep a daily diary of their oral temperatures to assess for potential infections.All patients with newly diagnosed, early stage, symptomatic myeloma will be eligible if they do not have sensitivity to the Quinolone group of antibiotics and have the intention to undergo anti-myeloma therapy. Patients will be identified by clinicians from myeloma clinics in hospitals and cancer centres throughout the UK.

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  11/WM/0220

• Date of REC Opinion

  28 Jul 2011

• REC opinion

  Favourable Opinion