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Oral antibiotic prophylaxis of early infection in multiple myeloma: a URCC/ECOG randomized phase III study
D H Vesole1, M M Oken, C Heckler
1The John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ 07601, USA. dvesole@humed.com
Abstract:
Multiple myeloma (MM) is a malignancy of clonal plasma cells, resulting in an increased production of ineffective immunoglobulins with suppression of non-involved immunoglobulins. Patients with MM are at increased risk of infectious complications, particularly streptococcal and staphylococcal infections. 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 MM. Patients with MM receiving initial chemotherapy were randomized on a 1:1:1 basis to daily ciprofloxacin (C; 500 mg twice daily), trimethoprim-sulfamethoxazole (T; DS twice daily) or observation (O) and evaluated for SBI (Eastern Cooperative Oncology Group ≥grade 3) for the first 2 months of treatment. From July 1998 to January 2008, 212 MM patients were randomized to C (n=69), T (n=76) or O (n=67). The incidence of SBI was comparable among groups: C=12.5%, T=6.8% and O=15.9%; P=0.218. Further, any infection during the first 2 months was also comparable (20% vs 23% vs 22%, respectively, P=0.954). We demonstrate that prophylactic antibiotics did not decrease the incidence of SBI (≥grade 3) within the first 2 months of treatment. We conclude that routine use of prophylactic antibiotics should not be mandated for patients receiving induction chemotherapy.
Insights
Prophylactic antibiotics like ciprofloxacin or trimethoprim-sulfamethoxazole did not reduce serious bacterial infections in newly diagnosed multiple myeloma patients during initial chemotherapy. Routine antibiotic prophylaxis is not recommended for these patients.
Area of Science:
- Hematology
- Oncology
- Infectious Disease
Background:
- Multiple myeloma (MM) is a plasma cell malignancy leading to immune dysfunction.
- Patients with MM face a heightened risk of severe bacterial infections (SBIs), especially from streptococci and staphylococci.
Purpose of the Study:
- To assess the efficacy of prophylactic antibiotics in preventing SBIs in newly diagnosed MM patients during the initial 2 months of chemotherapy.
- To compare the incidence of SBIs and overall infections across different prophylactic antibiotic regimens and observation.
Main Methods:
- A randomized controlled trial involving 212 newly diagnosed MM patients receiving initial chemotherapy.
- Patients were assigned to receive daily ciprofloxacin, trimethoprim-sulfamethoxazole, or observation.
- Serious bacterial infections (grade ≥3) were monitored for the first 2 months of treatment.
Main Results:
- The incidence of SBIs was comparable across the groups: 12.5% for ciprofloxacin, 6.8% for trimethoprim-sulfamethoxazole, and 15.9% for observation (P=0.218).
- Overall infection rates were also similar: 20% (ciprofloxacin), 23% (trimethoprim-sulfamethoxazole), and 22% (observation) (P=0.954).
Conclusions:
- Prophylactic antibiotics did not significantly decrease the incidence of serious bacterial infections within the first 2 months of induction chemotherapy for multiple myeloma.
- Routine prophylactic antibiotic use is not indicated for patients with newly diagnosed multiple myeloma undergoing initial chemotherapy.
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