Tackling early deaths and assessing quality of life in patients with myeloma: assessing the effect of preventative antibiotics on healthcare associated infections

Phase 1

• Conditions: Infections during early symptomatic multiple myeloma; MedDRA version: 18.1 Level: LLT Classification code 10028566 Term: Myeloma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-000366-35-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-05
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1000

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

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 since diagnosis) or concurrent active malignancies except surgically removed basal or squamous cell carcinoma of the skin, treated carcinoma insitu of the breast or cervix, or incidental histologic finding of prostate cancer (TNM stage of T1a or 1b). Patients with remote histories (>5 years) of other cured malignancies may be entered.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified