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NCT03030261 · ADVERSE EVENTS

Adverse events

Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma · Source last updated 2026-01-12

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
-Following induction and continuation therapy, AEs & all-cause mortality are collected from start of treatment through 30 days after treatment completion or the start of next anti-myeloma therapy. AEs were followed for median of 434 days, full range 83-1424 days. -During the follow-up phase, all-cause mortality data are collected through 5 years after treatment completion, up to 10 years. All-cause mortality were followed for median of 884 days, full range 187-1948 days.
Other-event reporting threshold
0%

The follow-up group is to show all-cause mortality only. Induction On Study group will show AEs and SAEs that occurred during that treatment time period and 30 days after that treatment time period if they stopped treatment in that time period. The Continuation group will show AEs and SAE that occurred during that treatment time period and for 30 days after that treatment time period if they stopped treatment in that time period.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Induction Therapy On Study

-Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.

6 / 1616 / 160 / 16
Continuation

* Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.

7 / 1818 / 180 / 18
Follow-up

-Participants will be followed annually for up to 5 years after removal from study or until death, whichever occurs first.

0 / 00 / 08 / 25

Group identifiers: EG000: Induction Therapy On Study · EG001: Continuation · EG002: Follow-up

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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Heart failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Infusion related reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    E. coli sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Lung infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Rhinovirus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Staph lugdunensis right toe

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 (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Chest tightness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Earwax buildup
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Double vision
Complete source fields
description
The follow-up group is to show all-cause mortality only. Induction On Study group will show AEs and SAEs that occurred during that treatment time period and 30 days after that treatment time period if they stopped treatment in that time period. The Continuation group will show AEs and SAE that occurred during that treatment time period and for 30 days after that treatment time period if they stopped treatment in that time period.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    16
    description
    -Patients will receive 2-6 cycles of salvage/induction per standard of care. After protocol version 02/13/2020, patients may have already received their induction therapy prior to enrolling in the study.
    id
    EG000
    other Num Affected
    16
    other Num At Risk
    16
    serious Num Affected
    6
    serious Num At Risk
    16
    title
    Induction Therapy On Study
  2. deaths Num Affected
    0
    deaths Num At Risk
    18
    description
    * Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT: * 10 mg/kg of elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+ * 2 mg pomalidomide daily on Days 1-21 of all cycles * 40 mg dexamethasone on Days 1 and 15 of all cycles for Cycles 1-6 followed by 40 mg on Day 1 for Cycles 7+ * Continuation therapy may continue until relapse or progression.
    id
    EG001
    other Num Affected
    18
    other Num At Risk
    18
    serious Num Affected
    7
    serious Num At Risk
    18
    title
    Continuation
  3. deaths Num Affected
    8
    deaths Num At Risk
    25
    description
    -Participants will be followed annually for up to 5 years after removal from study or until death, whichever occurs first.
    id
    EG002
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Follow-up
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Atrial fibrillation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Chest pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Chest tightness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Palpitations
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Sinus bradycardia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Sinus tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Earwax buildup
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Tinnitus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Blurred vision
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Double vision
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Heart failure
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Myocardial infarction
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Fatigue
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Fever
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Infusion related reaction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    E. coli sepsis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Lung infection
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Rhinovirus
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Sepsis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      16
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      18
    3. group Id
      EG002
      num At Risk
      0
    term
    Staph lugdunensis right toe
time Frame
-Following induction and continuation therapy, AEs & all-cause mortality are collected from start of treatment through 30 days after treatment completion or the start of next anti-myeloma therapy. AEs were followed for median of 434 days, full range 83-1424 days. -During the follow-up phase, all-cause mortality data are collected through 5 years after treatment completion, up to 10 years. All-cause mortality were followed for median of 884 days, full range 187-1948 days.

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Preserved source evidence · Not medical advice