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NCT06868654 · ADVERSE EVENTS

Adverse events

China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-04-23

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 32 months. 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 took at least 1 dose of study treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)

Chinese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.

25 / 3030 / 304 / 30
Daratumumab + Bor + Dex

Chinese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.

27 / 4039 / 4014 / 40

Group identifiers: EG000: Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex) · EG001: Daratumumab + Bor + Dex

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
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      30
      num Events
      17
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      7
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Herpes zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Febrile infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      30
      num Events
      12
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
      num Events
      8
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
      num Events
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Neutrophil count decreased

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
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      30
      num Events
      94
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      40
      num Events
      79
    term
    Platelet count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      30
      num Events
      52
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      40
      num Events
      93
    term
    White blood cell count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      30
      num Events
      45
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      40
      num Events
      34
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      30
      num Events
      79
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      40
      num Events
      29
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      30
      num Events
      57
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      40
      num Events
      78
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      30
      num Events
      40
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      40
      num Events
      58
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      30
      num Events
      21
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      40
      num Events
      17
    term
    Gamma-glutamyltransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      30
      num Events
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
      num Events
      15
    term
    Blood lactate dehydrogenase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
      num Events
      11
    term
    Weight decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      16
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      19
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Blood alkaline phosphatase increased
Complete source fields
description
Safety population included all randomized participants who took at least 1 dose of study treatment.
event Groups
  1. deaths Num Affected
    4
    deaths Num At Risk
    30
    description
    Chinese participants with Relapsed/Refractory Multiple Myeloma (RRMM) received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin on Day 1 of each 21-day Cycle until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/meter\^2 (m\^2) Bor administered subcutaneously (SC) once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex via oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
    id
    EG000
    other Num Affected
    30
    other Num At Risk
    30
    serious Num Affected
    25
    serious Num At Risk
    30
    title
    Belantamab Mafodotin + Bortezomib (Bor) + Dexamethasone (Dex)
  2. deaths Num Affected
    14
    deaths Num At Risk
    40
    description
    Chinese participants with RRMM received 16 mg/kg Daratumumab IV infusion once weekly of each 21-day cycle in Cycle 1 to Cycle 3; once every 3 weeks on Day 1 of each 21-day cycle in Cycle 4 to Cycle 8; and once every 4 weeks on day 1 of each 28-day cycle from cycle 9 onwards until disease progression, intolerable toxicity, death, informed consent withdrawal, or study end, whichever comes first in combination with 1.3 mg/m\^2 Bor administered SC once daily on Days 1, 4, 8 and 11 of each 21-day cycle along with 20 mg Dex oral tablet or IV infusion once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for a total of 8 cycles.
    id
    EG001
    other Num Affected
    39
    other Num At Risk
    40
    serious Num Affected
    27
    serious Num At Risk
    40
    title
    Daratumumab + Bor + Dex
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      23
      num At Risk
      30
      num Events
      94
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      40
      num Events
      79
    term
    Platelet count decreased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      30
      num Events
      52
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      40
      num Events
      93
    term
    White blood cell count decreased
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      30
      num Events
      45
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      40
      num Events
      34
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      30
      num Events
      79
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      40
      num Events
      29
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      30
      num Events
      57
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      40
      num Events
      78
    term
    Lymphocyte count decreased
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      30
      num Events
      40
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      40
      num Events
      58
    term
    Neutrophil count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      30
      num Events
      21
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      40
      num Events
      17
    term
    Gamma-glutamyltransferase increased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      30
      num Events
      33
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
      num Events
      15
    term
    Blood lactate dehydrogenase increased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
      num Events
      9
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
      num Events
      11
    term
    Weight decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      30
      num Events
      8
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      16
    term
    Blood bilirubin increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      30
      num Events
      12
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      19
    term
    Blood creatinine increased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      30
      num Events
      13
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Blood alkaline phosphatase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      30
      num Events
      17
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      40
      num Events
      7
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      30
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    Herpes zoster
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      40
      num Events
      2
    term
    COVID-19
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Gastroenteritis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Abdominal infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Bronchitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Febrile infection
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Urinary tract infection
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      30
      num Events
      12
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      40
      num Events
      8
    term
    Thrombocytopenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      30
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      40
      num Events
      1
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      30
      num Events
      10
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      40
      num Events
      5
    term
    Platelet count decreased
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    MedDRA 26.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      30
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      40
      num Events
      0
    term
    Neutrophil count decreased
time Frame
All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to approximately 32 months. 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