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Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma

Phase 3
18 Years
Open (Enrolling)
Infection, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma


- 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.

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 210 patients (70 per treatment arm) will be accrued for this

Inclusion Criteria


- Diagnosis of multiple myeloma (MM) based on one of the following:

- Bone marrow plasmacytosis with at least 10% abnormal plasma cells

- Multiple biopsy-proven plasmacytomas

- At least 1 of the following required:

- Myeloma protein in serum

- Myeloma protein in urine, i.e., free monoclonal light chain

- Radiologic evidence of osteolytic lesions

- Generalized osteoporosis qualifies only if bone marrow aspirate contains at
least 20% plasma cells

- No smoldering myeloma

- Planning to initiate 1 of the following regimens as primary therapy for MM within 3
days of study entry:

- Myelosuppressive chemotherapy

- High-dose dexamethasone

- Dexamethasone and thalidomide



- 18 and over

Performance status:

- Not specified


- Not specified


- Not specified


- Creatinine less than 5.0 mg/dL

- No requirement for dialysis at study entry

- If required after entry, patients continue study with adjusted medication


- Not pregnant

- No history of hypersensitivity to fluoroquinolones or trimethoprim

- At least 7 days since prior active infection


Biologic therapy:

- See Disease Characteristics

- No bone marrow transplant or autologous stem cell rescue planned within first 2
months of myeloma chemotherapy

- No concurrent prophylactic filgrastim (G-CSF) during the first 2 months of study

- No concurrent intravenous immunoglobulins


- See Disease Characteristics

- No prior chemotherapy (except mithramycin)

Endocrine therapy:

- See Disease Characteristics

- Prior corticosteroids allowed

- No prior high-dose dexamethasone


- At least 10 days since prior radiotherapy

- No radiotherapy planned for near future


- Not specified


- At least 7 days since prior antibiotics

- No concurrent theophylline

- No concurrent sucralfate or oral antacids if receive ciprofloxacin or ofloxacin

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Proportion of patients experiencing a serious bacterial infection

Outcome Time Frame:

during the first three months of chemotherapy

Safety Issue:


Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

University of Rochester


United States: Federal Government

Study ID:




Start Date:

March 1997

Completion Date:

August 2015

Related Keywords:

  • Infection
  • Multiple Myeloma and Plasma Cell Neoplasm
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • infection
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



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