Tackling EArly Morbidity and Mortality in myeloma (TEAMM)

Phase 3

Completed

• Conditions: Haematological Oncology; Disease: Myeloma; Cancer; Multiple myeloma

• Registration Number: ISRCTN51731976
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31668592 (added 04/11/2019) 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31690402 (added 08/11/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-10
• Study Completion: 2017-05-31
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 977

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified