Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
7 other identifiers
interventional
212
3 countries
45
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 1997
Longer than P75 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1997
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
February 13, 2015
CompletedNovember 11, 2015
October 1, 2015
14.1 years
November 1, 1999
July 10, 2014
October 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients Experiencing a Serious Bacterial Infection
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.
First three months of chemotherapy
Study Arms (3)
Ciprofloxacin or ofloxacin
EXPERIMENTALQuinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
TMP-SMX
EXPERIMENTALTMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
No prophylaxis
NO INTERVENTIONThe patient will receive no prophylactic antibiotics.
Interventions
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.
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.
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..
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gary Morrowlead
- National Cancer Institute (NCI)collaborator
- Eastern Cooperative Oncology Groupcollaborator
Study Sites (45)
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
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51104, 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
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, 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
St. Vincent's Comprehensive Cancer Center - Manhattan
New York, New York, 10011, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466, United States
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, 27534-9479, 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 - Columbus
Columbus, Ohio, 43215, United States
CCOP - Dayton
Dayton, Ohio, 45429, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, 97225, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Chester County Hospital
West Chester, Pennsylvania, 19380, 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
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, 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
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
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34, Peru
Pretoria Academic Hospital
Pretoria, 0001, South Africa
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Charles E. Heckler, PhD, MS. Research Assistant Professor
- Organization
- University of Rochester Medical Center
Study Officials
- STUDY CHAIR
Gary R. Morrow, PhD, MS
University of Rochester
- STUDY CHAIR
Martin M. Oken, MD
CCOP - Metro-Minnesota
- STUDY CHAIR
Claire Pomeroy, MD
University of California, Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, UR NCORP Research BAase
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
March 1, 1997
Primary Completion
April 1, 2011
Study Completion
January 1, 2012
Last Updated
November 11, 2015
Results First Posted
February 13, 2015
Record last verified: 2015-10