Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
18 Years
N/A
Both
Infection, Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Oral Antibiotic Prophylaxis of Early Infection in 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.
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 210 patients (70 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of multiple myeloma (MM) based on one of the following:
- Bone marrow plasmacytosis with at least 10% abnormal plasma cells
- Multiple biopsy-proven plasmacytomas
- At least 1 of the following required:
- Myeloma protein in serum
- Myeloma protein in urine, i.e., free monoclonal light chain
- Radiologic evidence of osteolytic lesions
- Generalized osteoporosis qualifies only if bone marrow aspirate contains at
least 20% plasma cells
- No smoldering myeloma
- Planning to initiate 1 of the following regimens as primary therapy for MM within 3
days of study entry:
- Myelosuppressive chemotherapy
- High-dose dexamethasone
- Dexamethasone and thalidomide
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine less than 5.0 mg/dL
- No requirement for dialysis at study entry
- If required after entry, patients continue study with adjusted medication
guidelines
Other:
- Not pregnant
- No history of hypersensitivity to fluoroquinolones or trimethoprim
- At least 7 days since prior active infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No bone marrow transplant or autologous stem cell rescue planned within first 2
months of myeloma chemotherapy
- No concurrent prophylactic filgrastim (G-CSF) during the first 2 months of study
participation
- No concurrent intravenous immunoglobulins
Chemotherapy:
- See Disease Characteristics
- No prior chemotherapy (except mithramycin)
Endocrine therapy:
- See Disease Characteristics
- Prior corticosteroids allowed
- No prior high-dose dexamethasone
Radiotherapy:
- At least 10 days since prior radiotherapy
- No radiotherapy planned for near future
Surgery:
- Not specified
Other:
- At least 7 days since prior antibiotics
- No concurrent theophylline
- No concurrent sucralfate or oral antacids if receive ciprofloxacin or ofloxacin
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Proportion of patients experiencing a serious bacterial infection
Outcome Time Frame:
during the first three months of chemotherapy
Safety Issue:
No
Principal Investigator
Gary R. Morrow, PhD, MS
Investigator Role:
Study Chair
Investigator Affiliation:
University of Rochester
Authority:
United States: Federal Government
Study ID:
CDR0000065093
NCT ID:
NCT00002850
Start Date:
March 1997
Completion Date:
August 2015
Related Keywords:
- Infection
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- infection
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| Mercy Cancer Center at Mercy Medical Center | Canton, Ohio 44708 |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44109 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls, South Dakota 57117-5039 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| CCOP - Marshfield Clinic Research Foundation | Marshfield, Wisconsin 54449 |
| McCreery Cancer Center at Ottumwa Regional | Ottumwa, Iowa 52501 |
| Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
| Dickinson County Healthcare System | Iron Mountain, Michigan 49801 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
| Warren Hospital | Phillipsburg, New Jersey 08865 |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | Bronx, New York 10466 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| St. Vincent's Comprehensive Cancer Center - Manhattan | New York, New York 10011 |
| Lewistown Hospital | Lewistown, Pennsylvania 17044 |
| Mount Nittany Medical Center | State College, Pennsylvania 16803 |
| Chester County Hospital | West Chester, Pennsylvania 19380 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
