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← Multiple Myeloma

NCT00002850 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-multiple-myeloma
nct id
NCT00002850
trial label
Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
1
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    outcome key
    om-0000
    source section id
    NCT00002850-om-0000
    source outcome index
    0
    endpoint
    Proportion of Patients Experiencing a Serious Bacterial Infection
    endpoint definition
    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.
    time origin
    First three months of chemotherapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Ciprofloxacin or Ofloxacin
    regimen
    ciprofloxacin: 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. ofloxacin: 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.
    analyzed count
    64
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00002850-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    outcome key
    om-0000
    arm key
    OG001
    arm label
    TMP-SMX
    regimen
    trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole 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..
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00002850-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    outcome key
    om-0000
    arm key
    OG002
    arm label
    No Prophylaxis
    regimen
    The patient will receive no prophylactic antibiotics.
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00002850-om-0000#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    harm key
    EG000
    source section id
    NCT00002850-ae
    event group key
    EG000
    event group label
    Ciprofloxacin or Ofloxacin
    serious affected
    1
    serious at risk
    69
    other affected
    1
    other at risk
    69
    frequency threshold
    0
    collection period
    Three months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    harm key
    EG001
    source section id
    NCT00002850-ae
    event group key
    EG001
    event group label
    TMP-SMX
    serious affected
    2
    serious at risk
    76
    other affected
    1
    other at risk
    76
    frequency threshold
    0
    collection period
    Three months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-multiple-myeloma
    nct id
    NCT00002850
    harm key
    EG002
    source section id
    NCT00002850-ae
    event group key
    EG002
    event group label
    Observation
    serious affected
    0
    serious at risk
    67
    other affected
    0
    other at risk
    67
    frequency threshold
    0
    collection period
    Three months.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice