At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of multiple myeloma with bone marrow plasmacytosis >10% abnormal plasma cells or multiple biopsy-proven plasmacytomas, plus myeloma protein in serum/urine or radiologic evidence of osteolytic lesions
- ✓No active infection for 7 days prior and off all antibiotics for 7 days prior to enrollment
- ✓No radiotherapy in the 10 days preceding study entry
- ✓Primary myeloma therapy must start within 3 days of study entry; myelosuppressive chemotherapy, high-dose dexamethasone, or dexamethasone-based regimens acceptable
- ✕Smoldering myeloma
- ✕History of hypersensitivity to fluoroquinolones or trimethoprim
- ✕Bone marrow transplant or autologous stem cell rescue planned during first 2 months of treatment
- ✕Currently taking theophylline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Oral Antibiotic Prophylaxis of Early Infection in Multiple Myeloma
In Brief
A Phase 3 clinical trial evaluating ciprofloxacin, ofloxacin, and 1 other intervention for Infection and Multiple Myeloma. Completed, enrolled 212 participants across 45 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
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..