Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
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| ClinicalTrials.gov Identifier: NCT00002850 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : February 13, 2015
Last Update Posted : November 11, 2015
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Infection Multiple Myeloma | Drug: ciprofloxacin Drug: ofloxacin Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole | Phase 3 |
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 2treatment 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: The patient will receive no prophylaxis.
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 212 patients (71 per treatment arm) will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 212 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma |
| Study Start Date : | March 1997 |
| Actual Primary Completion Date : | April 2011 |
| Actual Study Completion Date : | January 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ciprofloxacin or ofloxacin
Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours. |
Drug: 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.
Other Name: Cipro Drug: ofloxacin 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.
Other Name: Floxin |
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Experimental: TMP-SMX
TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
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Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole
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..
Other Names:
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No Intervention: No prophylaxis
The patient will receive no prophylactic antibiotics.
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- Proportion of Patients Experiencing a Serious Bacterial Infection [ Time Frame: First three months of chemotherapy ]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.
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| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion:
- Patient must have a diagnosis of multiple myeloma confirmed by the presence of:
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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.
Exclusion:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002850
Show 45 study locations
| 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 |
| Responsible Party: | Gary Morrow, Director, UR NCORP Research BAase, University of Rochester NCORP Research Base |
| ClinicalTrials.gov Identifier: | NCT00002850 |
| Other Study ID Numbers: |
CDR0000065093 U10CA037420 ( U.S. NIH Grant/Contract ) URCC-U10994 ( Other Identifier: University of Rochester Cancer Center ) NCI-C95-0001 ( Other Identifier: NIH/NCI DCP ) URCC-URRSRB-6993 ( Other Identifier: University of Rochester IRB ) NCI-P96-0073 ( Other Identifier: NCI ) ECOG-U1099 ( Other Identifier: ECOG ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | February 13, 2015 |
| Last Update Posted: | November 11, 2015 |
| Last Verified: | October 2015 |
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stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma infection |
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Infection Communicable Diseases Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders |
Immune System Diseases Ciprofloxacin Ofloxacin Trimethoprim Sulfamethoxazole Anti-Bacterial Agents Anti-Infective Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Infective Agents, Urinary |