Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
- Conditions
- InfectionMultiple Myeloma
- Interventions
- Registration Number
- NCT00002850
- Lead Sponsor
- Gary Morrow
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 212
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TMP-SMX 160 mg trimethoprim and 800 mg sulfamethoxazole TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours Ciprofloxacin or ofloxacin ciprofloxacin Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours. Ciprofloxacin or ofloxacin ofloxacin Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
- Primary Outcome Measures
Name Time Method Proportion of Patients Experiencing a Serious Bacterial Infection First three months of chemotherapy This study evaluated the impact of prophylactic antibiotics on the incidence of serious bacterial infections (SBIs) during the first 2 months of treatment in patients with newly diagnosed multiple myeloma. Patients with multiple myeloma receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation and evaluated for SBI for the first 2 months of treatment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
🇺🇸Bronx, New York, United States
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Lewistown Hospital
🇺🇸Lewistown, Pennsylvania, United States
CCOP - Metro-Minnesota
🇺🇸St. Louis Park, Minnesota, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
CCOP - Hematology-Oncology Associates of Central New York
🇺🇸East Syracuse, New York, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
Green Bay Oncology, Limited - Sturgeon Bay
🇺🇸Sturgeon Bay, Wisconsin, United States
Pretoria Academic Hospital
🇿🇦Pretoria, South Africa
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Chester County Hospital
🇺🇸West Chester, Pennsylvania, United States
Dickinson County Healthcare System
🇺🇸Iron Mountain, Michigan, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Green Bay Oncology, Limited - Oconto Falls
🇺🇸Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Vincent's Comprehensive Cancer Center - Manhattan
🇺🇸New York, New York, United States
Mercy Cancer Center at Mercy Medical Center
🇺🇸Canton, Ohio, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸Ottumwa, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸Escanaba, Michigan, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center
🇺🇸Flemington, New Jersey, United States
Warren Hospital
🇺🇸Phillipsburg, New Jersey, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Goldsboro, North Carolina, United States
Mount Nittany Medical Center
🇺🇸State College, Pennsylvania, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States