Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting

Contact information



Primary contact

Ms Jill Waddingham


Contact details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
United Kingdom

Additional identifiers

EudraCT number

2011-000366-35 number

Protocol/serial number


Study information

Scientific title

Tackling early morbidity and mortality in myeloma: assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections



Study hypothesis

TEAMM is a randomized, double-blind, placebo-controlled multi-centre phase III clinical trial assessing the benefit of antibiotic prophylaxis and its effect on health care associated infections.

The trial hypotheses are that levofloxacin used once daily as anti-bacterial prophylaxis in newly diagnosed symptomatic myeloma will:

1. Reduce the rate of febrile episodes, hospitalisation, and death
2. Increase response to anti-myeloma therapy
3. Improve quality of life and overall survival

The trial will also test if levofloxacin affects the carriage of and invasive infection by three important groups of bacteria; C. difficile, S. aureus (including methicillin-resistant Staphylococcus aureus [MRSA]) and Extended-Spectrum Beta-Lactamases (ESBL) coliforms.

1. Is the carriage of these organisms increased in patients receiving levofloxacin compared to those receiving placebo?
2. Is the carriage of these organisms associated with later invasive infections?
3. Does levofloxacin increase the rate of invasive infections by these three groups of organisms?

Ethics approval

First MREC, 27 July 2011, ref: 11/WM/0220

Study design

Randomised, interventional, prevention

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Haematological Oncology; Disease: Myeloma


Antibiotic Prophylaxis: 500mg of Levofloxacin or Placebo to match will be taken daily for 12 weeks during anti-myeloma chemotherapy

Intervention type



Phase III

Drug names

Primary outcome measures

Number of febrile episodes from randomisation up to 12 weeks

Secondary outcome measures

1. Carriage and invasive infections with S. aureus, C. difficile and ESBL coliforms between 12 and 16 weeks to assess for delayed affects from the intervention that is stopped at 12 weeks
2. Carriage and invasive infections with S. aureus, C. difficile and ESBL coliforms from randomisation up to 12 weeks
3. Days on antibiotic therapy for treatment of infection from randomisation up to 12 weeks
4. Health economics - captured daily for the first 16 weeks post randomisation
5. Incidence of microbiologically proven infections, the pathogens and their susceptibility to antibiotics from randomisation up to 12 weeks
6. Number of days in hospital on antibiotics from randomisation up to 12 weeks
7. Number of clinically documented total infections, episodes of severe sepsis (CTCAE grade 3 or 4) from randomisation up to 12 weeks
8. Number of days in hospital from randomisation up to 12 weeks
9. Number of deaths and infection related deaths from randomisation up to 12 weeks
10. Overall survival at 1 year post randomisation
11. Patient characteristics, steroid usage and indices of immunocompetence from randomisation up to 12 weeks
12. Quality of life measured 4 weekly up to 16 weeks from randomisatio
13. Resonse to anti-myeloma therapy at 16 weeks. Because of the half life of paraproteins measurement of myeloma response cannot be under 16 weeks
14. Response to anti-myeloma therapy and its relationship to infection from randomisation up to 12 weeks

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Aged minimum of 21 years and able to give informed consent
2. Patient with newly diagnosed symptomatic myeloma based on internationally agreed criteria, within 7 days of starting a programme of anti-myeloma therapy (or within 14 days of starting anti-myeloma therapy if already on a broad spectrum antibacterial agent)
3. Provision of written informed consent
4. Male or female participants

Participant type


Age group




Target number of participants

Planned Sample Size: 800; UK Sample Size: 800

Participant exclusion criteria

1. Patients with contraindication to Levofloxacin:
1.1. Known to have sensitivity / allergy to Levofloxacin or other quinolones
1.2. Patients with a history of tendon disorders related to fluoroquinolone administration
1.3. Patients receiving other prophylactic antibiotic treatment (excluding pneumocystis prophylaxis if regarded as essential)
1.4. Patients receiving amiodarone or arsenic trioxide
1.5. Patients on active antiepileptic treatment
2. Women of childbearing age who are not willing to use appropriate methods of contraception to prevent pregnancy or women that are breastfeeding
3. Patient thought to have mandatory requirement for prophylactic antibiotics
4. Patient who is not going to receive anti myeloma therapy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
United Kingdom

Sponsor information


University of Birmingham (UK)

Sponsor details

Department of Immunity and Infection
B15 2TT
United Kingdom

Sponsor type




Funder type


Funder name

NIHR - Health Technology Assessment Programme (HTA)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes