Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy

Phase 3

Completed

Conditions: Infection
Multiple Myeloma

Interventions: Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole
Drug: ciprofloxacin
Drug: ofloxacin

Registration Number: NCT00002850

Lead Sponsor: Gary Morrow

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 212

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMP-SMX	160 mg trimethoprim and 800 mg sulfamethoxazole	TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
Ciprofloxacin or ofloxacin	ciprofloxacin	Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
Ciprofloxacin or ofloxacin	ofloxacin	Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Experiencing a Serious Bacterial Infection	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (45): MBCCOP - Gulf Coast
🇺🇸
Mobile, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸
Mobile, Alabama, United States
Cedar Rapids Oncology Associates
🇺🇸
Cedar Rapids, Iowa, United States
McCreery Cancer Center at Ottumwa Regional
🇺🇸
Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸
Sioux City, Iowa, United States
CCOP - Wichita
🇺🇸
Wichita, Kansas, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Green Bay Oncology, Limited - Escanaba
🇺🇸
Escanaba, Michigan, United States
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MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States