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NCT00644228 · ADVERSE EVENTS

Adverse events

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma · Source last updated 2026-07-29

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%

The number at risk excludes patients who went off study prior to starting treatment and were thus not evaluated for toxicity. The adverse events reported here are current up through the time of upload of these data.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I (Dexamethasone and Lenalidomide)

Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO

105 / 222209 / 222Not reported / Not reported
Arm II (Dexamethasone, Lenalidomide, Bortezomib)

Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO

124 / 237232 / 237Not reported / Not reported

Group identifiers: EG000: Arm I (Dexamethasone and Lenalidomide) · EG001: Arm II (Dexamethasone, Lenalidomide, Bortezomib)

Serious adverse events

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

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      237
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Cardiac Arrhythmia-Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      237
    term
    Cardiac General-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Cardiac-ischemia/infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Conduction abnormality NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Left ventricular diastolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Pain - Cardiac/heart
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      237
    term
    SVT and nodal arrhythmia - Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    SVT and nodal arrhythmia - Atrial flutter

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      162
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      172
      num At Risk
      237
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      237
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      237
    term
    Cataract
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      237
    term
    Dry eye syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      237
    term
    Vision-blurred vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      237
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      237
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      237
    term
    Distention/bloating, abdominal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      237
    term
    Dry mouth/salivary gland (xerostomia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      237
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      237
    term
    Gastrointestinal-Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      237
    term
    Heartburn/dyspepsia
Complete source fields
description
The number at risk excludes patients who went off study prior to starting treatment and were thus not evaluated for toxicity. The adverse events reported here are current up through the time of upload of these data.
event Groups
  1. description
    Patients receive dexamethasone PO QD on days 1, 8, 15, and 22 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    EG000
    other Num Affected
    209
    other Num At Risk
    222
    serious Num Affected
    105
    serious Num At Risk
    222
    title
    Arm I (Dexamethasone and Lenalidomide)
  2. description
    Patients receive dexamethasone PO QD on days 1, 2, 4, 5, 8, 9, 11, and 12; lenalidomide PO QD on days 1-14; and bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Bortezomib: Given IV Dexamethasone: Given PO Laboratory Biomarker Analysis: Optional correlative studies Lenalidomide: Given PO
    id
    EG001
    other Num Affected
    232
    other Num At Risk
    237
    serious Num Affected
    124
    serious Num At Risk
    237
    title
    Arm II (Dexamethasone, Lenalidomide, Bortezomib)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      162
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      172
      num At Risk
      237
    term
    Hemoglobin
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      237
    term
    Tinnitus
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      237
    term
    Cataract
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      237
    term
    Dry eye syndrome
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      53
      num At Risk
      237
    term
    Vision-blurred vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      237
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      99
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      113
      num At Risk
      237
    term
    Diarrhea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      237
    term
    Distention/bloating, abdominal
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      237
    term
    Dry mouth/salivary gland (xerostomia)
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      237
    term
    Flatulence
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      237
    term
    Gastrointestinal-Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      237
    term
    Heartburn/dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      237
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Hemolysis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Cardiac Arrhythmia-Other
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      237
    term
    Cardiac General-Other
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Cardiac-ischemia/infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Conduction abnormality NOS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      237
    term
    Left ventricular diastolic dysfunction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Left ventricular systolic dysfunction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    Pain - Cardiac/heart
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      237
    term
    SVT and nodal arrhythmia - Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      222
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      237
    term
    SVT and nodal arrhythmia - Atrial flutter

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