Infections during early symptomatic multiple myeloma MedDRA version: 18.1 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Prixoter 250mg film-coated tablets
Product Name: Levofloxacin
Pharmaceutical Form: Tablet
INN or Proposed INN: Levofloxacin
Sponsors
University of Birmingham
University of Warwick
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 21 years and able to give informed consent • Patient with newly diagnosed symptomatic myeloma based on internationally agreed criteria, within 7 days of starting a program of anti-myeloma therapy (or within 14 days of starting anti-myeloma therapy if already on a broad spectrum antibacterial agent) • Provision of written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 500
Exclusion criteria
Exclusion criteria: Patients with the following characteristics are ineligible for this trial: • Patients with contraindication to Levofloxacin:- ? known to have sensitivity / allergy to Levofloxacin or other quinolones ? Patients with a history of tendon disorders related to fluoroquinolone administration ? Patients receiving amiodarone or arsenic trioxide ? Patients on active antiepileptic treatment • Women of childbearing age who are not willing to use appropriate methods of contraception to prevent pregnancy or women that are breastfeeding • Patient thought to have mandatory requirement for antibacterial prophylaxis (with the exception of pneumocystis prophylaxis if regarded as essential) • Previous treatment for myeloma, except for the following: ? Local radiotherapy to relieve bone pain or spinal cord compression ? Prior bisphosphonate treatment • Previous (5 years) of other cured malignancies may be entered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the risks, benefits and cost effectiveness of levofloxacin in newly diagnosed symptomatic myeloma by a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. ;Secondary Objective: n/a; Primary end point(s): Primary outcome from start of trial treatment to 12 weeks • Time to first febrile episode. A febrile episode is identified and counted by: • A single oral temperature =38° C (recorded EITHER by a health care professional OR by the patient/carer provided that the patient/carer has been trained and assessed as competent in temperature taking) AND that the patient is then given anti-infectives • A single febrile episode is defined as the initial febrile event and any subsequent fevers until that course of anti-infectives have been stopped • Capture of Febrile episodes will be via 1) documentation in hospital and 2) via patient diary cards. Patient diary cards will form part of the CRF returned four weekly. ;Timepoint(s) of evaluation of this end point: Number of febrile episodes will be assessed at 4 weekly intervals up to 12 weeks. Patients will complete a daily diary with their oral temperature. This alongside any hospital documentation detailing febrile episodes within each of the 4 week periods will be summarised at 12 weeks. Patients will stop taking the trial drug at 12 weeks. Febrile episodes will be monitored actively up to 16 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcomes from start of trial treatment to 12 weeks • 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 • Response to anti-myeloma therapy at 16 weeks. Because of the half life of paraproteins measurement of myeloma response cannot be undertaken until a minimum of 4 weeks after an intervention • Quality of life (4 weekly questionnaires up to 16 weeks) • Health economics (daily diary card which captures elements of health resource use in combination with information captured on the CRF) • Overall survival ; Timepoint(s) of evaluation of this end point: Carriage and invasive infections with S.aureus, C. difficile and ESBL coliforms will be evaluated up to 16 weeks from start of trial treatment. This will be via samples collected 4 weekly until 16 weeks. Response to anti-myeloma therepy will be evaluated at 16 weeks post start of trial treatment. Quality of life will be evaluated 4 weekly until 16 weeks post start of trial treatment Health econmics questions will be delivered to patients daily via a patient diary card. These will be summarised and evaluated 4 weekly up until 16 weeks Overall survival will be evaluated at the end of the trial rather than the end of the treatment period. | — |
Countries
United Kingdom
Outcome results
None listed