Multiple Myeloma Clinical Trial
Official title:
Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection
in patients with multiple myeloma and may improve their response to chemotherapy.
PURPOSE: This randomized clinical trial is studying antibiotics to see how well they work
compared to no antibiotics in preventing early infection in patients with multiple myeloma.
OBJECTIVES:
- Evaluate whether oral antibiotic prophylaxis with co-trimoxazole (TMP-SMX) versus
ciprofloxacin (CPFX) or ofloxacin versus no prophylaxis will significantly reduce rates
of serious bacterial infections during the first 3 months of chemotherapy in patients
with multiple myeloma.
- Determine whether antibiotic prophylaxis with TMP-SMX or CPFX (or ofloxacin) is
associated with an increased incidence of nonbacterial infection or an increased rate
of infection from organisms resistant to prophylactic antibiotics.
- Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as
TMP-SMX without the associated toxic effects.
- Evaluate whether protection against early infection in multiple myeloma patients can
improve their response to initial chemotherapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating
center. Patients are randomized to 1 of 2treatment arms.
- Arm I: Patients receive co-trimoxazole every 12 hours for 2 months followed by
observation for 2 months.
- Arm II: Patients receive oral ciprofloxacin or ofloxacin every 12 hours for 2 months
followed by observation for 1 month.
- Arm III: The patient will receive no prophylaxis.
Patients continue their randomly assigned treatment throughout any infection in addition to
any treatment needed for infection. Patients also remain on their randomly assigned
treatment if chemotherapy is discontinued, changed, or delayed during the 3 month study.
Patients are followed at 6 months, 1 year, and 2 years.
PROJECTED ACCRUAL: A total of 212 patients (71 per treatment arm) will be accrued for this
study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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