Oral antibiotic prophylaxis of early infection in multiple myeloma: a URCC/ECOG randomized phase III study

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.

Multiple myeloma and infections: a population-based study on 9253 multiple myeloma patients

“…Vesole et al performed a randomized clinical trial including 212 MM patients and found no decrease in serious bacterial infections when comparing patients receiving ciprofloxacin, trimethoprimsulfamethoxazole, or observation only. 32 Their study did not include patients treated with novel agents and analyzed only infections during the first two months, and thus only included the pre-ASCT period. Furthermore, the role of prophylactic immunoglobulin needs to be established, as the rationale for its use is mainly based on one randomized trial in MM plateau phase.…”

Guidelines for screening and management of late and long‐term consequences of myeloma and its treatment

“…Insufficient data are available to recommend prophylactic antibiotics routinely at any stage of myeloma (NICE, ), although their importance is well recognised in patients with other causes of immunodeficiency, such as neutropenia, following chemotherapy. Trials of co‐trimoxazole versus placebo or ciprofloxacin or co‐trimoxazole versus placebo in newly‐diagnosed myeloma patients have shown limited benefits of co‐trimoxazole, but were too small to draw reliable conclusions (Oken et al , ; Vesole et al , ). The current 800‐patient TEAMM trial (Tackling EArly Morbidity and Mortality in myeloma), which compares prophylactic levofloxacin with placebo in newly diagnosed myeloma patients, may address these issues (ISRCTN 51731976).…”

Limiting early mortality: Do's and don'ts in the management of patients with newly diagnosed multiple myeloma

“…One small prospective trial randomized newly diagnosed patients to oral trimethoprim-sulfamethoxazole (TMP-SMX) or observation during the first 2 months of induction chemotherapy and demonstrated a lower risk of infection in the treatment group [60]. However, a larger, randomized control trial of oral antibiotic prophylaxis (ciprofloxacin vs. TMP-SMX vs. placebo) given during the first 2 months of induction therapy did not show a reduction in infections [61]. Given the lack of adequate prospective data, the risk of antimicrobial resistance and Clostridium difficile infections, routine prophylaxis is not advised.…”