Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infection; Multiple Myeloma and Plasma Cell Neoplasm
Intervention: ciprofloxacin (Drug); ofloxacin (Drug); trimethoprim-sulfamethoxazole (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Rochester Official(s) and/or principal investigator(s):
Jane T. Hickok, MD, MPH, Study Chair, Affiliation: James P. Wilmot Cancer Center
Gary R. Morrow, PhD, MS, Affiliation: University of Rochester
Martin M. Oken, MD, Study Chair, Affiliation: CCOP - Metro-Minnesota
Claire Pomeroy, MD, Affiliation: University of California, Davis
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.
Clinical Details
Official title: Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
Study design: Supportive Care, Randomized, Active Control
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 3 treatment 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: Patients receive no prophylactic antibiotics and are observed for 3 months.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Instituto Nacional de Enfermedades Neoplasicas, Lima Lima 34, Peru
Pretoria Academic Hospital, Pretoria 0001, South Africa
MBCCOP - Gulf Coast, Mobile, Alabama 36606, United States
Mobile Infirmary Medical Center, Mobile, Alabama 36652-2144, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa 52403, United States
McCreery Cancer Center at Ottumwa Regional, Ottumwa, Iowa 52501, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa 51104, United States
Siouxland Hematology-Oncology Associates, LLP, Sioux City, Iowa 51101, United States
St. Luke's Regional Medical Center, Sioux City, Iowa 51104, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States
CCOP - Kalamazoo, Kalamazoo, Michigan 49007-3731, United States
Dickinson County Healthcare System, Iron Mountain, Michigan 49801, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan 49431, United States
CCOP - Metro-Minnesota, St. Louis Park, Minnesota 55416, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Kansas City, Kansas City, Missouri 64131, United States
Hunterdon Regional Cancer Center at Hunterdon Medical Center, Flemington, New Jersey 08822, United States
Warren Hospital, Phillipsburg, New Jersey 08865, United States
CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York 13057, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center, Bronx, New York 10466, United States
St. Vincent's Comprehensive Cancer Center - Manhattan, New York, New York 10011, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina 27534-9479, United States
CCOP - Columbus, Columbus, Ohio 43215, United States
CCOP - Dayton, Dayton, Ohio 45429, United States
Mercy Cancer Center at Mercy Medical Center, Canton, Ohio 44708, United States
MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland, Ohio 44109, United States
CCOP - Columbia River Oncology Program, Portland, Oregon 97225, United States
Chester County Hospital, West Chester, Pennsylvania 19380, United States
Lewistown Hospital, Lewistown, Pennsylvania 17044, United States
Mount Nittany Medical Center, State College, Pennsylvania 16803, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States
CCOP - Greenville, Greenville, South Carolina 29615, United States
Avera Cancer Institute, Sioux Falls, South Dakota 57105, United States
Medical X-Ray Center, PC, Sioux Falls, South Dakota 57105, United States
Sanford Cancer Center at Sanford USD Medical Center, Sioux Falls, South Dakota 57117-5039, United States
CCOP - Northwest, Tacoma, Washington 98405-0986, United States
Bay Area Cancer Care Center at Bay Area Medical Center, Marinette, Wisconsin 54143, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin 54154, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin 54235, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin 54303, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54301-3526, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin 54303, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin 54307-3508, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 1997
Last updated: May 23, 2008
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