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| Sponsors and Collaborators: |
University of Rochester 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
Show 45 Study Locations| 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 |
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stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma infection |
|
Trimethoprim Immunoproliferative Disorders Sulfamethoxazole Blood Protein Disorders Hematologic Diseases Blood Coagulation Disorders Ofloxacin Vascular Diseases Folate Anti-Infective Agents, Urinary Trimethoprim-Sulfamethoxazole Combination Paraproteinemias |
Folinic Acid Folic Acid Antagonists Hemostatic Disorders Vitamin B9 Multiple Myeloma Folic Acid Antimalarials Ciprofloxacin Anti-Bacterial Agents Hemorrhagic Disorders Lymphoproliferative Disorders Neoplasms, Plasma Cell |
|
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Trimethoprim Molecular Mechanisms of Pharmacological Action Blood Protein Disorders 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 Multiple Myeloma |