Tackling EArly Morbidity and Mortality in myeloma (TEAMM)
| ISRCTN | ISRCTN51731976 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51731976 |
| EudraCT/CTIS number | 2011-000366-35 |
| Secondary identifying numbers | 10626; HTA 08/116/69 |
- Submission date
- 10/08/2011
- Registration date
- 10/08/2011
- Last edited
- 08/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Contact information
Ms Kerry Raynes
Scientific
Scientific
Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Study information
| Study design | Randomised interventional prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Tackling early morbidity and mortality in myeloma: assessing the benefit of antibiotic prophylaxis and its effect on healthcare associated infections |
| Study acronym | TEAMM |
| 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? More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/0811669 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0020/52076/PRO-08-116-69.pdf |
| Ethics approval(s) | First MREC, 27/07/2011, ref: 11/WM/0220 |
| Condition | Haematological Oncology; Disease: Myeloma |
| Intervention | Antibiotic prophylaxis: 500mg of Levofloxacin or Placebo to match will be taken daily for 12 weeks during anti-myeloma chemotherapy |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Levofloxacin |
| Primary outcome measure | 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 study start date | 01/09/2011 |
| Overall study end date | 31/05/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: up to 1000; UK Sample Size: up to 1000 |
| Total final enrolment | 977 |
| 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 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 | 13/04/2012 |
| Recruitment end date | 30/04/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom
Coventry
CV4 7AL
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Department of Immunity and Infection
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Website | http://www.birmingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Health Technology Assessment Programme
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date. 14/03/2018: Results were presented at the American Society for Hematology annual meeting 2017 https://ash.confex.com/ash/2017/webprogram/Paper106598.html |
| IPD sharing plan | The datasets generated and/or analysed during the current study are available on reasonable request from teamm@warwick.ac.uk, subject to approval from the trial management group and a data transfer agreement and contract. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| Results article | results | 01/12/2019 | 04/11/2019 | Yes | No |
| Results article | results | 01/11/2019 | 08/11/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
08/11/2019: Publication reference added.
04/11/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
19/12/2018: Cancer Research UK lay results summary link added to Results (plain English).
14/03/2018; The following changes were made:
1. Intention to publish date was changed from 01/07/2017 to 31/05/2018.
2. Reference for results presented at conference were added.
3. Trial setting was corrected from GP practices to Hospital
4. Trial phase was added.
04/11/2016: the following changes were made to the trial record:
1. The overall trial start date was changed from 01/11/2011 to 01/09/2011.
2. The overall trial end date was changed from 30/11/2015 to 31/05/2017.
3. The target number of participants was changed from 800 to 1000.
