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| Sponsor: | University of Rochester |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002850 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Infection Multiple Myeloma and Plasma Cell Neoplasm |
Drug: ciprofloxacin Drug: ofloxacin Drug: trimethoprim-sulfamethoxazole |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Active Control |
| Official Title: | Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma |
| Estimated Enrollment: | 210 |
| Study Start Date: | March 1997 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center. Patients are randomized to 1 of 3 treatment arms.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma (MM) based on one of the following:
At least 1 of the following required:
Radiologic evidence of osteolytic lesions
Planning to initiate 1 of the following regimens as primary therapy for MM within 3 days of study entry:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
No requirement for dialysis at study entry
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| MBCCOP - Gulf Coast | |
| Mobile, Alabama, United States, 36606 | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36652-2144 | |
| United States, Iowa | |
| Cedar Rapids Oncology Associates | |
| Cedar Rapids, Iowa, United States, 52403 | |
| McCreery Cancer Center at Ottumwa Regional | |
| Ottumwa, Iowa, United States, 52501 | |
| Mercy Medical Center - Sioux City | |
| Sioux City, Iowa, United States, 51104 | |
| Siouxland Hematology-Oncology Associates, LLP | |
| Sioux City, Iowa, United States, 51101 | |
| St. Luke's Regional Medical Center | |
| Sioux City, Iowa, United States, 51104 | |
| United States, Kansas | |
| CCOP - Wichita | |
| Wichita, Kansas, United States, 67214-3882 | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| CCOP - Kalamazoo | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Dickinson County Healthcare System | |
| Iron Mountain, Michigan, United States, 49801 | |
| Green Bay Oncology, Limited - Escanaba | |
| Escanaba, Michigan, United States, 49431 | |
| United States, Minnesota | |
| CCOP - Metro-Minnesota | |
| St. Louis Park, Minnesota, United States, 55416 | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| United States, New Jersey | |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | |
| Flemington, New Jersey, United States, 08822 | |
| Warren Hospital | |
| Phillipsburg, New Jersey, United States, 08865 | |
| United States, New York | |
| CCOP - Hematology-Oncology Associates of Central New York | |
| East Syracuse, New York, United States, 13057 | |
| Our Lady of Mercy Medical Center Comprehensive Cancer Center | |
| Bronx, New York, United States, 10466 | |
| St. Vincent's Comprehensive Cancer Center - Manhattan | |
| New York, New York, United States, 10011 | |
| United States, North Carolina | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| United States, Ohio | |
| CCOP - Columbus | |
| Columbus, Ohio, United States, 43215 | |
| CCOP - Dayton | |
| Dayton, Ohio, United States, 45429 | |
| Mercy Cancer Center at Mercy Medical Center | |
| Canton, Ohio, United States, 44708 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Oregon | |
| CCOP - Columbia River Oncology Program | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| Chester County Hospital | |
| West Chester, Pennsylvania, United States, 19380 | |
| Lewistown Hospital | |
| Lewistown, Pennsylvania, United States, 17044 | |
| Mount Nittany Medical Center | |
| State College, Pennsylvania, United States, 16803 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, South Carolina | |
| CCOP - Greenville | |
| Greenville, South Carolina, United States, 29615 | |
| United States, South Dakota | |
| Avera Cancer Institute | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Medical X-Ray Center, PC | |
| Sioux Falls, South Dakota, United States, 57105 | |
| Sanford Cancer Center at Sanford USD Medical Center | |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| United States, Washington | |
| CCOP - Northwest | |
| Tacoma, Washington, United States, 98405-0986 | |
| United States, Wisconsin | |
| Bay Area Cancer Care Center at Bay Area Medical Center | |
| Marinette, Wisconsin, United States, 54143 | |
| CCOP - Marshfield Clinic Research Foundation | |
| Marshfield, Wisconsin, United States, 54449 | |
| Green Bay Oncology, Limited - Oconto Falls | |
| Oconto Falls, Wisconsin, United States, 54154 | |
| Green Bay Oncology, Limited - Sturgeon Bay | |
| Sturgeon Bay, Wisconsin, United States, 54235 | |
| Green Bay Oncology, Limited at St. Mary's Hospital | |
| Green Bay, Wisconsin, United States, 54303 | |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54301-3526 | |
| St. Mary's Hospital Medical Center - Green Bay | |
| Green Bay, Wisconsin, United States, 54303 | |
| St. Vincent Hospital Regional Cancer Center | |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Peru | |
| Instituto Nacional de Enfermedades Neoplasicas | |
| Lima, Peru, Lima 34 | |
| South Africa | |
| Pretoria Academic Hospital | |
| Pretoria, South Africa, 0001 | |
| Study Chair: | Jane T. Hickok, MD, MPH | James P. Wilmot Cancer Center |
| Investigator: | Gary R. Morrow, PhD, MS | University of Rochester |
| Study Chair: | Martin M. Oken, MD | CCOP - Metro-Minnesota |
| Investigator: | Claire Pomeroy, MD | University of California, Davis |
More Information
| Study ID Numbers: | CDR0000065093, URCC-U10994, NCI-C95-0001, URCC-URRSRB-6993, NCI-P96-0073, ECOG-U1099 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002850 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma infection |
|
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Trimethoprim Molecular Mechanisms of Pharmacological Action Blood Protein Disorders Ofloxacin Paraproteinemias Trimethoprim-Sulfamethoxazole Combination Renal Agents Hemostatic Disorders Infection Antimalarials Anti-Bacterial Agents Ciprofloxacin |
Antiparasitic Agents Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases Nucleic Acid Synthesis Inhibitors Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Sulfamethoxazole Hematologic Diseases Vascular Diseases Anti-Infective Agents, Urinary Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions |