NCT00002850

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

Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (actual)
• Sponsor: Gary Morrow · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Infection
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	ciprofloxacin	Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
DRUG	ofloxacin	Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.
DRUG	160 mg trimethoprim and 800 mg sulfamethoxazole	Begin oral TMP-SMX when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\] every 12 hours for two months..

Timeline

• Start date: 1997-03-01
• Primary completion: 2011-04-01
• Completion: 2012-01-01
• First posted: 2003-01-27
• Last updated: 2015-11-11
• Results posted: 2015-02-13

Locations

45 sites across 3 countries: United States, Peru, South Africa