Tackling EArly Morbidity and Mortality in myeloma (TEAMM)

ISRCTN	ISRCTN51731976
DOI	https://doi.org/10.1186/ISRCTN51731976
Clinical Trials Information System (CTIS)	2011-000366-35
Protocol serial number	10626; HTA 08/116/69
Sponsor	University of Birmingham (UK)
Funder	Health Technology Assessment Programme

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 of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-antibiotic-prevent-infections-people-having-treatment-myeloma-teamm

Contact information

Ms Kerry Raynes
Scientific

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised interventional prevention trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Levofloxacin
Primary outcome measure(s)	Number of febrile episodes from randomisation up to 12 weeks
Key secondary outcome measure(s)	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
Completion date	31/05/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1000
Total final enrolment	977
Key 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
Key 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
Date of first enrolment	13/04/2012
Date of final enrolment	30/04/2016

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Warwick Medical School

Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Plain English results				No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.