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NCT04484623 · ADVERSE EVENTS

Adverse events

Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma · Source last updated 2026-06-12

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
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.
Other-event reporting threshold
5%

Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Belantamab Mafodotin+Pomalidomide+Dexamethasone

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.

95 / 150148 / 15048 / 155
Pomalidomide+Bortezomib+Dexamethasone

Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.

65 / 145130 / 14554 / 147

Group identifiers: EG000: Belantamab Mafodotin+Pomalidomide+Dexamethasone · EG001: Pomalidomide+Bortezomib+Dexamethasone

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
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      150
      num Events
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      145
      num Events
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      145
      num Events
      6
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
      num Events
      3
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
      num Events
      3
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
      num Events
      1
    term
    Sinus node dysfunction

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
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      150
      num Events
      52
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      145
      num Events
      63
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      150
      num Events
      206
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      145
      num Events
      191
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      150
      num Events
      113
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      145
      num Events
      99
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      150
      num Events
      56
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      145
      num Events
      16
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      150
      num Events
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Corneal epithelial microcysts
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      150
      num Events
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Corneal opacity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      150
      num Events
      232
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      145
      num Events
      17
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      150
      num Events
      198
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      145
      num Events
      16
    term
    Eye irritation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      150
      num Events
      100
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      145
      num Events
      7
    term
    Eye pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      150
      num Events
      257
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      145
      num Events
      12
    term
    Foreign body sensation in eyes
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      150
      num Events
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
      num Events
      1
    term
    Keratitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      150
      num Events
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Keratopathy
Complete source fields
description
Safety population included all randomized participants who receive at least 1 dose of study intervention (any component). Data for All-Cause Mortality was collected for the ITT Population (all randomized participants whether or not randomized treatment was administered). Serious and Other (Not Including Serious) Adverse Events were collected for the Safety Population (all randomized participants who received at least 1 dose of study intervention \[any component\]).
event Groups
  1. deaths Num Affected
    48
    deaths Num At Risk
    155
    description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of Cycle 1 and 1.9 mg/kg on Day 1 of Cycle 2 onwards in each 28-day cycle, in combination with oral 4 mg per day Pomalidomide capsule on Days 1 to 21 of each 28-day cycle; and oral 40 mg per day Dexamethasone tablet on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
    id
    EG000
    other Num Affected
    148
    other Num At Risk
    150
    serious Num Affected
    95
    serious Num At Risk
    150
    title
    Belantamab Mafodotin+Pomalidomide+Dexamethasone
  2. deaths Num Affected
    54
    deaths Num At Risk
    147
    description
    Participants with RRMM received oral 4 mg per day Pomalidomide capsule on Days 1 to 14 of each 21-day cycle, in combination with subcutaneous (SC) injection of 1.3 mg/meter\^2(m\^2) Bortezomib on Days 1, 4, 8, 11, of each 21-day cycle for Cycles 1 through 8, and on Days 1, 8, of each 21-day cycle for Cycles 9+, and oral 20 mg Dexamethasone tablet on Days 1, 2, 4, 5, 8, 9, 11, 12, of each 21-day cycle for Cycles 1 through 8 and then on Days 1, 2, 8, 9, every 3 Weeks (Q3W) from Cycles 9 onwards until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of another anti-myeloma therapy or end of study, whichever occurs first.
    id
    EG001
    other Num Affected
    130
    other Num At Risk
    145
    serious Num Affected
    65
    serious Num At Risk
    145
    title
    Pomalidomide+Bortezomib+Dexamethasone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      150
      num Events
      52
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      145
      num Events
      63
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      69
      num At Risk
      150
      num Events
      206
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      145
      num Events
      191
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      54
      num At Risk
      150
      num Events
      113
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      145
      num Events
      99
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      150
      num Events
      56
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      145
      num Events
      16
    term
    Cataract
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      150
      num Events
      51
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Corneal epithelial microcysts
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      150
      num Events
      23
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Corneal opacity
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      150
      num Events
      232
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      145
      num Events
      17
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      75
      num At Risk
      150
      num Events
      198
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      145
      num Events
      16
    term
    Eye irritation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      49
      num At Risk
      150
      num Events
      100
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      145
      num Events
      7
    term
    Eye pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      91
      num At Risk
      150
      num Events
      257
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      145
      num Events
      12
    term
    Foreign body sensation in eyes
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      150
      num Events
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
      num Events
      1
    term
    Keratitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      150
      num Events
      14
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Keratopathy
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      150
      num Events
      6
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      150
      num Events
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      145
      num Events
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      145
      num Events
      6
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
      num Events
      3
    term
    Atrial fibrillation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      145
      num Events
      3
    term
    Cardiac failure
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Cardiac failure congestive
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      150
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      145
      num Events
      0
    term
    Myocardial infarction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA v26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      150
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      145
      num Events
      1
    term
    Sinus node dysfunction
time Frame
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 174 weeks. The results presented are until the primary completion date. Additional results will be provided within a year of study completion.

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Preserved source evidence · Not medical advice