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NCT00002850 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2015-11-11

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.

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What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Proportion of Patients Experiencing a Serious Bacterial Infection

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Quinolone: Ciprofloxacin 500 mg every 12 hours or Ofloxacin400 mg every 12 hours.
    intervention Names
    1. Drug: ciprofloxacin
    2. Drug: ofloxacin
    label
    Ciprofloxacin or ofloxacin
    type
    EXPERIMENTAL
  2. description
    TMP-SMX: 160 mg trimethoprim and 800 mg sulfamethoxazole every 12 hours
    intervention Names
    1. Drug: 160 mg trimethoprim and 800 mg sulfamethoxazole
    label
    TMP-SMX
    type
    EXPERIMENTAL
  3. description
    The patient will receive no prophylactic antibiotics.
    label
    No prophylaxis
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. Ciprofloxacin or ofloxacin
    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.
    name
    ciprofloxacin
    other Names
    1. Cipro
    type
    DRUG
  2. arm Group Labels
    1. Ciprofloxacin or ofloxacin
    description
    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.
    name
    ofloxacin
    other Names
    1. Floxin
    type
    DRUG
  3. arm Group Labels
    1. TMP-SMX
    description
    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..
    name
    160 mg trimethoprim and 800 mg sulfamethoxazole
    other Names
    1. TMP-SMX
    2. Septra
    3. Bactrim
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
212
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Proportion of Patients Experiencing a Serious Bacterial Infection
    time Frame
    First three months of chemotherapy
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
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        start
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      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
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      source file sha256
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      source json pointer
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      source record id
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      source string sha256
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    Preserved source evidence · Not medical advice