Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
Condition: Infection; Multiple Myeloma
MeSH terms: Infections; Communicable Diseases; Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: ciprofloxacin; ofloxacin; 160 mg trimethoprim and 800 mg sulfamethoxazole
Intervention description: 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.; 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.; 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..
Intervention MeSH terms: Ciprofloxacin; Ofloxacin; Trimethoprim; Sulfamethoxazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; infection

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.
    

Eligibility criteria:

        Inclusion:

          -  Patient must have a diagnosis of multiple myeloma confirmed by the presence of:

          -  Bone marrow plasmacytosis with >10% abnormal plasma cells or multiple biopsy-proven
             plasmacytomas, and at least one of the criteria below must be documented:

               1. Myeloma protein in the serum

               2. Myeloma protein in the urine (free monoclonal light chain)

               3. Radiologic evidence of osteolytic lesions (generalized osteoporosis qualifies
                  only if the bone marrow aspirate contains >20% plasma cells)

          -  Patients must have no active infection during the prior seven days and be off all
             antibiotics for the prior seven days.

          -  Patients cannot have received radiotherapy during the preceding ten days.

          -  Primary therapy for multiple myeloma must start within three days after entry to this
             study. For purposes of eligibility for this study, myelosuppressive chemotherapy or
             high-dose dexamethasone based regimens are acceptable as primary therapy. The
             high-dose dexamethasone regimen must include, at a minimum, dexamethasone 40 mg per
             day days 1-4, 9-12, 17-20 for the first cycle and 40 mg per day on days 1-4 of the
             second cycle.

          -  Patients who are to receive dexamethasone alone or dexamethasone with thalidomide are
             among those eligible for this protocol.

          -  Patients must have a serum creatinine <5.0 mg/dl and not require dialysis at the time
             of study entry. If patients require dialysis after enrollment, they can continue on
             the protocol using the adjusted medication guidelines

          -  Written informed consent must be obtained prior to entry.

        Exclusion:

        - Patients with smoldering myeloma, history of hypersensitivity to fluoroquinolones or
        trimethoprim, bone marrow transplant or autologous stem cell rescue planned during the
        first two months of treatment, patients taking theophylline, or patients previously treated
        with chemotherapy or high-dose dexamethasone