Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-26 @ 6:39 PM
Study NCT ID:
NCT00002850
Status:
COMPLETED
Last Update Posted:
2015-11-11
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D014295', 'term': 'Trimethoprim'}, {'id': 'D013420', 'term': 'Sulfamethoxazole'}, {'id': 'D015662', 'term': 'Trimethoprim, Sulfamethoxazole Drug Combination'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'checkler@urmc.rochester.edu', 'phone': '585-273-1141', 'title': 'Charles E. Heckler, PhD, MS. Research Assistant Professor', 'organization': 'University of Rochester Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Three months.', 'eventGroups': [{'id': 'EG000', 'title': 'Ciprofloxacin or Ofloxacin', 'description': 'ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.\n\nofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.', 'otherNumAtRisk': 69, 'otherNumAffected': 1, 'seriousNumAtRisk': 69, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'TMP-SMX', 'description': 'trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \\[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\\] every 12 hours for two months..', 'otherNumAtRisk': 76, 'otherNumAffected': 1, 'seriousNumAtRisk': 76, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Observation', 'description': 'No Prophylaxis: The patient will receive no prophylactic antibiotics.', 'otherNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI bleed', 'notes': 'Hospitalized with GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Hospitalized for evaluation of pain, shortness of breath, cough; death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal failure', 'notes': 'Hospitalized for acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection, thrush, allergic reaction', 'notes': 'Hospitalized for bacterial infection, oral thrush, allergic reaction to sulfa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 67, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients Experiencing a Serious Bacterial Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin or Ofloxacin', 'description': 'ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.\n\nofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.'}, {'id': 'OG001', 'title': 'TMP-SMX', 'description': 'trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \\[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\\] every 12 hours for two months..'}, {'id': 'OG002', 'title': 'No Prophylaxis', 'description': 'The patient will receive no prophylactic antibiotics.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '23.2'}, {'value': '6.8', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '15.1'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '7.9', 'upperLimit': '27.3'}]}]}], 'analyses': [{'pValue': '0.218', 'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'H0: There is no significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.\n\nHa: There is a significant difference in the incidence of severe bacterial infections among all three arms during the first 2 months of treatment at the two-sided 0.05 significance level.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Target accrual=70 patients per arm to provide 92% power to detect a difference of 0.31 vs. 0.08 in the proportion of patients with serious infection.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'First three months of chemotherapy', 'description': '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.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciprofloxacin or Ofloxacin', 'description': 'ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.\n\nofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.'}, {'id': 'FG001', 'title': 'TMP-SMX', 'description': 'trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \\[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\\] every 12 hours for two months..'}, {'id': 'FG002', 'title': 'Observation', 'description': 'Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '74'}, {'groupId': 'FG002', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciprofloxacin or Ofloxacin', 'description': 'ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.\n\nofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.'}, {'id': 'BG001', 'title': 'TMP-SMX', 'description': 'trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \\[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\\] every 12 hours for two months..'}, {'id': 'BG002', 'title': 'Observation', 'description': 'No prophylaxis: The patient will receive no prophylactic antibiotics.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'groupId': 'BG000', 'lowerLimit': '32.4', 'upperLimit': '86.0'}, {'value': '62.6', 'groupId': 'BG001', 'lowerLimit': '36.7', 'upperLimit': '85.7'}, {'value': '65.0', 'groupId': 'BG002', 'lowerLimit': '36.7', 'upperLimit': '89.3'}, {'value': '63.2', 'groupId': 'BG003', 'lowerLimit': '32.4', 'upperLimit': '89.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '160', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '212', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Infection in last 6 months', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '184', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Chemotherapy regimen', 'classes': [{'title': 'Melphalan, Prednisone', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}, {'title': 'VBMCP', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Vincristine, Adriamycin, Dexamethasone', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'VBMCP=vincristine, carmustine, melphalan, cyclophosphamide, and prednisone', 'unitOfMeasure': 'participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) performance status', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1.1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '0.8', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '1.0', 'groupId': 'BG003', 'lowerLimit': '0', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'description': "ECOG PERFORMANCE STATUS: Used by doctors and researchers to assess how a patient's disease is progressing.\n\n0: Fully active, able to carry on pre-disease performance\n\n1. Restricted in physically strenuous activity but ambulatory; able to carry out work of a light or sedentary nature\n2. Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours\n3. Capable of limited selfcare, confined to bed or chair more than 50% of waking hours\n4. Completely disabled. Cannot carry on selfcare. Confined to bed or chair\n5. Dead", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Patients with symptomatic and untreated MM receiving chemotherapy without an active infection during the 7 days prior to initiation of chemotherapy and off antibiotics for the prior 7 days were eligable for this study. They were required to receive myelosuppressive and/or immunosuppressive chemotherapy, and were randomized on a 1:1 basis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-13', 'studyFirstSubmitDate': '1999-11-01', 'resultsFirstSubmitDate': '2014-07-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-11', 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients Experiencing a Serious Bacterial Infection', 'timeFrame': 'First three months of chemotherapy', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stage I multiple myeloma', 'stage II multiple myeloma', 'stage III multiple myeloma', 'infection'], 'conditions': ['Infection', 'Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection in patients with multiple myeloma and may improve their response to chemotherapy.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* 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.\n* Evaluate whether oral antibiotic prophylaxis with CPFX or ofloxacin is as effective as TMP-SMX without the associated toxic effects.\n* Evaluate whether protection against early infection in multiple myeloma patients can improve their response to initial chemotherapy.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center. Patients are randomized to 1 of 2treatment arms.\n\n* Arm I: Patients receive co-trimoxazole every 12 hours for 2 months followed by observation for 2 months.\n* Arm II: Patients receive oral ciprofloxacin or ofloxacin every 12 hours for 2 months followed by observation for 1 month.\n* Arm III: The patient will receive no prophylaxis.\n\nPatients 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.\n\nPatients are followed at 6 months, 1 year, and 2 years.\n\nPROJECTED ACCRUAL: A total of 212 patients (71 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n* Patient must have a diagnosis of multiple myeloma confirmed by the presence of:\n* Bone marrow plasmacytosis with \\>10% abnormal plasma cells or multiple biopsy-proven plasmacytomas, and at least one of the criteria below must be documented:\n\n 1. Myeloma protein in the serum\n 2. Myeloma protein in the urine (free monoclonal light chain)\n 3. Radiologic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains \\>20% plasma cells)\n* Patients must have no active infection during the prior seven days and be off all antibiotics for the prior seven days.\n* Patients cannot have received radiotherapy during the preceding ten days.\n* 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.\n* Patients who are to receive dexamethasone alone or dexamethasone with thalidomide are among those eligible for this protocol.\n* 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\n* Written informed consent must be obtained prior to entry.\n\nExclusion:\n\n\\- 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'}, 'identificationModule': {'nctId': 'NCT00002850', 'briefTitle': 'Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CDR0000065093'}, 'secondaryIdInfos': [{'id': 'U10CA037420', 'link': 'https://reporter.nih.gov/quickSearch/U10CA037420', 'type': 'NIH'}, {'id': 'URCC-U10994', 'type': 'OTHER', 'domain': 'University of Rochester Cancer Center'}, {'id': 'NCI-C95-0001', 'type': 'OTHER', 'domain': 'NIH/NCI DCP'}, {'id': 'URCC-URRSRB-6993', 'type': 'OTHER', 'domain': 'University of Rochester IRB'}, {'id': 'NCI-P96-0073', 'type': 'OTHER', 'domain': 'NCI'}, {'id': 'ECOG-U1099', 'type': 'OTHER', 'domain': 'ECOG'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ciprofloxacin or ofloxacin', 'description': 'Quinolone:\n\nCiprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.', 'interventionNames': ['Drug: ciprofloxacin', 'Drug: ofloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'TMP-SMX', 'description': 'TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours', 'interventionNames': ['Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole']}, {'type': 'NO_INTERVENTION', 'label': 'No prophylaxis', 'description': 'The patient will receive no prophylactic antibiotics.'}], 'interventions': [{'name': 'ciprofloxacin', 'type': 'DRUG', 'otherNames': ['Cipro'], 'description': 'Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.', 'armGroupLabels': ['Ciprofloxacin or ofloxacin']}, {'name': 'ofloxacin', 'type': 'DRUG', 'otherNames': ['Floxin'], 'description': 'Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.', 'armGroupLabels': ['Ciprofloxacin or ofloxacin']}, {'name': '160 mg trimethoprim and 800 mg sulfamethoxazole', 'type': 'DRUG', 'otherNames': ['TMP-SMX', 'Septra', 'Bactrim'], 'description': 'Begin oral TMP-SMX when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet \\[TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole\\] every 12 hours for two months..', 'armGroupLabels': ['TMP-SMX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36606', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - Gulf Coast', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36652-2144', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Mobile Infirmary Medical Center', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'Cedar Rapids Oncology Associates', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '52501', 'city': 'Ottumwa', 'state': 'Iowa', 'country': 'United States', 'facility': 'McCreery Cancer Center at Ottumwa Regional', 'geoPoint': {'lat': 41.02001, 'lon': -92.4113}}, {'zip': '51101', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology Associates, LLP', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center - Sioux City', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '51104', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': "St. Luke's Regional Medical Center", 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49431', 'city': 'Escanaba', 'state': 'Michigan', 'country': 'United States', 'facility': 'Green Bay Oncology, Limited - Escanaba', 'geoPoint': {'lat': 45.74525, 'lon': -87.06458}}, {'zip': '49801', 'city': 'Iron Mountain', 'state': 'Michigan', 'country': 'United States', 'facility': 'Dickinson County Healthcare System', 'geoPoint': {'lat': 45.82023, 'lon': -88.06596}}, {'zip': '49007-3731', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Kalamazoo', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55416', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'CCOP - Metro-Minnesota', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hunterdon Regional Cancer Center at Hunterdon Medical Center', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '08865', 'city': 'Phillipsburg', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Warren Hospital', 'geoPoint': {'lat': 40.69371, 'lon': -75.19018}}, {'zip': '13057', 'city': 'East Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - Hematology-Oncology Associates of Central New York', 'geoPoint': {'lat': 43.06534, 'lon': -76.07853}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Vincent's Comprehensive Cancer Center - Manhattan", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10466', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Our Lady of Mercy Medical Center Comprehensive Cancer Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27534-9479', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'CCOP - Southeast Cancer Control Consortium', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Mercy Cancer Center at Mercy Medical Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Cancer Care Center at MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45429', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'CCOP - Dayton', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'CCOP - Columbia River Oncology Program', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033-0850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Cancer Institute at Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '17044', 'city': 'Lewistown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lewistown Hospital', 'geoPoint': {'lat': 40.59924, 'lon': -77.57138}}, {'zip': '16803', 'city': 'State College', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mount Nittany Medical Center', 'geoPoint': {'lat': 40.79339, 'lon': -77.86}}, {'zip': '19380', 'city': 'West Chester', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Chester County Hospital', 'geoPoint': {'lat': 39.96097, 'lon': -75.60804}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Greenville', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Avera Cancer Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Medical X-Ray Center, PC', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '57117-5039', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford Cancer Center at Sanford USD Medical Center', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '98405-0986', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'CCOP - Northwest', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '54301-3526', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': "Green Bay Oncology, Limited at St. Mary's Hospital", 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54303', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': "St. Mary's Hospital Medical Center - Green Bay", 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54307-3508', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'St. Vincent Hospital Regional Cancer Center', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '54143', 'city': 'Marinette', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Bay Area Cancer Care Center at Bay Area Medical Center', 'geoPoint': {'lat': 45.09998, 'lon': -87.63066}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'CCOP - Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '54154', 'city': 'Oconto Falls', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Green Bay Oncology, Limited - Oconto Falls', 'geoPoint': {'lat': 44.87388, 'lon': -88.14288}}, {'zip': '54235', 'city': 'Sturgeon Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Green Bay Oncology, Limited - Sturgeon Bay', 'geoPoint': {'lat': 44.83416, 'lon': -87.37704}}, {'zip': 'Lima 34', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto Nacional de Enfermedades Neoplasicas', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '0001', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Pretoria Academic Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'overallOfficials': [{'name': 'Gary R. Morrow, PhD, MS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Rochester'}, {'name': 'Martin M. Oken, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CCOP - Metro-Minnesota'}, {'name': 'Claire Pomeroy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gary Morrow', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, UR NCORP Research BAase', 'investigatorFullName': 'Gary Morrow', 'investigatorAffiliation': 'University of Rochester NCORP Research Base'}}}}