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NCT00538824 · ADVERSE EVENTS

Adverse events

Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2018-06-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
DexTR (All Patients)

All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt

0 / 53 / 5Not reported / Not reported

Group identifiers: EG000: DexTR (All Patients)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      sepsis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Fever
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Cardiac Arrythmia
    Complete source fields
    event Groups
    1. description
      All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
      id
      EG000
      other Num Affected
      3
      other Num At Risk
      5
      serious Num Affected
      0
      serious Num At Risk
      5
      title
      DexTR (All Patients)
    frequency Threshold
    5
    other Events
    1. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      sepsis
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Infections and infestations
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Fever
    3. assessment Type
      NON_SYSTEMATIC_ASSESSMENT
      organ System
      Cardiac disorders
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        5
      term
      Cardiac Arrythmia

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice