Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy

Not Applicable

• Conditions: -C900 Multiple myeloma; Multiple myeloma; C900

• Registration Number: PER-011-06
• Lead Sponsor: EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients must have a confirmed diagnosis of multiple myeloma.
2. Primary therapy for myeloma should be started up to three days after entering the study. For the purposes of eligibility for this study, regimens based on myelosuppressive chemotherapy or high doses of dexamethasone are accepted as primary therapy.
3. Patients should have a serum creatinine <5.0 mg / dl and not require dialysis at the time of entering the study.
4. Written informed consent must be obtained prior to entry into the study.
5. Patient must be over 18 years old.

Exclusion Criteria

1. Patients must not have an active infection during the previous 7 days and have not taken any antibiotic 7 days before the start of the study.
2. Patients can not have received radiotherapy 10 days prior.
3. Patients treated with chemotherapy or high doses of dexamethasone are not eligible.
4. Patients who take theophyllines are excluded.
5. Patients with marrow transplant or autologous stem cell rescue plan during the first 2 months of treatment are ineligible for the study.
6. Patients with a history of hypersensitivity to fiuoroquinolones or trimeterpin will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation applying the Common Toxicity Criteria (ECOG).<br><br>Measure:Proportion of patients with a serious bacterial infection during the first 2 months of chemotherapy.<br>Timepoints:At the beginning of the treatment and during months 1 and 2.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Clinical evaluation of adverse events and categorization according to their severity.<br>Measure:Toxicity of medicines.<br>Timepoints:Monthly evaluation during the first 3 months and when an adverse event occurs.<br>;<br>Outcome name:Incidence of infections: Clinical evaluation.<br>Response rate to initial chemotherapy: Using the myeloma response criteria and categorizing the response in: 1) Objective response. 2) Almost complete answer. 3) Complete answer. 4) Plateau disease. 5) No response. 6) Recurrence or progression.<br><br>Measure:Incidence of non-bacterial or antibiotic resistant infections or incidence of infection during the month after the end of antibiotic therapy. Response rate to initial chemotherapy.<br>Timepoints:Clinical evaluation: When an event occurs.<br>Myeloma response criteria: Before starting treatment, in months 1, 2, 3 and 6 and in years 1 and 2.<br>