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Home > "A" Clinical Trials Conditions > Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy  Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
For Condition: stage 3 multiple myeloma,stage 1 multiple myeloma,Infection,stage 2 multiple myeloma
Status: Recruiting
Sponsor(s): James P. Wilmot Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomized clinical trial to compare the effectiveness of antibiotics or no antibiotics for the prevention of early infection in treating patients with multiple myeloma.
Details: 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 will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of multiple myeloma 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 - No active infection and off antibiotics for 7 days - Chemotherapy begins within 3 days after entry PATIENT CHARACTERISTICS: Age: - Any age Performance status: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Creatinine less than 5.0 mg/dL - No requirement for dialysis at entry - If required after entry, patients continue study with adjusted medication guidelines Other: - No history of hypersensitivity to fluoroquinolones or trimethoprim - At least 7 days since prior active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - No bone marrow transplant or autologous stem cell rescue planned within first 2 months of myeloma chemotherapy - No concurrent prophylactic filgrastim (G-CSF) or intravenous immunoglobulins Chemotherapy: - See Disease Characteristics - No prior chemotherapy (except mithramycin) Endocrine therapy: - Prior corticosteroids allowed Radiotherapy: - At least 10 days since 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneHickok, Study Chair, James P. Wilmot Cancer Center
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-569-3730
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 612-863-8585
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester, New York, 14642
United States
Recruiting Jane Hickok 585-275-5513
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1677
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5900
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-832-1093
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36688
United States
Recruiting Marcel Conrad 251-435-3941
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. *Recruiting*
Syracuse, New York, 13217
United States
Recruiting Jeffrey Kirshner 315-472-7504
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
CCOP - Virginia Mason Research Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Andrew Jacobs 206-341-0446
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6600
Additional Information:
Study ID Numbers: CDR0000065093; URCC-U10994,NCI-C95-0001,URCC-10994P(M),URCC-URRSRB-6993,NCI-P96-0073
Study Start Date:
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002850
Other Stage 1 Multiple Myeloma Studies:
1. Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
2. Combination Chemotherapy With or Without Interferon alfa in Treating Patients With Previously Untreated Multiple Myeloma
3. Thalidomide, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
4. Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
5. Vaccine Therapy Plus GM-CSF in Treating Patients With Multiple Myeloma Undergoing Bone Marrow or Peripheral Stem Cell Transplantation
Related Studies:
Other stage 1 multiple myeloma Clinical Trials
Other Wisconsin Clinical Trials
Other Marshfield Clinical Trials
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
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