Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Infection, Multiple Myeloma
About this trial
This is an interventional supportive care trial for Infection focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, infection
Eligibility Criteria
Inclusion: Patient must have a diagnosis of multiple myeloma confirmed by the presence of: Bone marrow plasmacytosis with >10% abnormal plasma cells or multiple biopsy-proven plasmacytomas, and at least one of the criteria below must be documented: Myeloma protein in the serum Myeloma protein in the urine (free monoclonal light chain) Radiologic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains >20% plasma cells) Patients must have no active infection during the prior seven days and be off all antibiotics for the prior seven days. Patients cannot have received radiotherapy during the preceding ten days. Primary therapy for multiple myeloma must start within three days after entry to this study. For purposes of eligibility for this study, myelosuppressive chemotherapy or high-dose dexamethasone based regimens are acceptable as primary therapy. The high-dose dexamethasone regimen must include, at a minimum, dexamethasone 40 mg per day days 1-4, 9-12, 17-20 for the first cycle and 40 mg per day on days 1-4 of the second cycle. Patients who are to receive dexamethasone alone or dexamethasone with thalidomide are among those eligible for this protocol. Patients must have a serum creatinine <5.0 mg/dl and not require dialysis at the time of study entry. If patients require dialysis after enrollment, they can continue on the protocol using the adjusted medication guidelines Written informed consent must be obtained prior to entry. Exclusion: - Patients with smoldering myeloma, history of hypersensitivity to fluoroquinolones or trimethoprim, bone marrow transplant or autologous stem cell rescue planned during the first two months of treatment, patients taking theophylline, or patients previously treated with chemotherapy or high-dose dexamethasone
Sites / Locations
- MBCCOP - Gulf Coast
- Mobile Infirmary Medical Center
- Cedar Rapids Oncology Associates
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- CCOP - Wichita
- Beth Israel Deaconess Medical Center
- Green Bay Oncology, Limited - Escanaba
- Dickinson County Healthcare System
- CCOP - Kalamazoo
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- CCOP - Kansas City
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- Warren Hospital
- Our Lady of Mercy Medical Center Comprehensive Cancer Center
- CCOP - Hematology-Oncology Associates of Central New York
- St. Vincent's Comprehensive Cancer Center - Manhattan
- CCOP - Southeast Cancer Control Consortium
- Mercy Cancer Center at Mercy Medical Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- CCOP - Columbus
- CCOP - Dayton
- CCOP - Columbia River Oncology Program
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lewistown Hospital
- Mount Nittany Medical Center
- Chester County Hospital
- CCOP - Greenville
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- CCOP - Northwest
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- CCOP - Marshfield Clinic Research Foundation
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Instituto Nacional de Enfermedades Neoplasicas
- Pretoria Academic Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Ciprofloxacin or ofloxacin
TMP-SMX
No prophylaxis
Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
The patient will receive no prophylactic antibiotics.