Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00002850|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : February 13, 2015
Last Update Posted : November 11, 2015
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|
- 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|
|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|
Experimental: Ciprofloxacin or ofloxacin
Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
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
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
TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
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..
No Intervention: No prophylaxis
The patient will receive no prophylactic antibiotics.
- 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.
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
|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|