None listed
Conditions
Interventions
This group will receive prophylactic treatment during the performance of their chemotherapy with trimethoprim / sulfamethoxazole 800/160 mg mg BID PO for 2 months.
Group name:ARM C Type of group
This group will not receive prophylactic treatment during the performance of their chemotherapy. It will only be observed during the 2 months of treatment and during the month of follow-up
Sponsors
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation applying the Common Toxicity Criteria (ECOG). Measure:Proportion of patients with a serious bacterial infection during the first 2 months of chemotherapy. Timepoints:At the beginning of the treatment and during months 1 and 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of adverse events and categorization according to their severity. Measure:Toxicity of medicines. Timepoints:Monthly evaluation during the first 3 months and when an adverse event occurs. ; Outcome name:Incidence of infections: Clinical evaluation. 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. 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. Timepoints:Clinical evaluation: When an event occurs. Myeloma response criteria: Before starting treatment, in months 1, 2, 3 and 6 and in years 1 and 2. | — |
Countries
India, Peru, United States
Outcome results
None listed