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NCT03934684 · ADVERSE EVENTS

Adverse events

Study to Evaluate Safety Tolerability & Efficacy of Kyprolis (Carfilzomib) in Relapsed or Refractory Multiple Myeloma · Source last updated 2026-05-11

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
For all-cause mortality reporting, from enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months. For Adverse Event reporting, from the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months.
Other-event reporting threshold
5%

All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.

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

Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.

11 / 4945 / 492 / 49
Carfilzomib and Dexamethasone (Kd)

Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.

20 / 5242 / 522 / 52

Group identifiers: EG000: Carfilzomib, Lenalidomide and Dexamethasone (KRd) · EG001: Carfilzomib and Dexamethasone (Kd)

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 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Thrombotic microangiopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Acute cardiac event
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      52
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Cardiotoxicity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Visual impairment
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Neutropenic colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Amoebic dysentery
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Bronchitis

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 28.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      52
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      52
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      52
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      52
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      52
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      52
    term
    Pyrexia
Complete source fields
description
All-cause mortality is reported for all participants enrolled in the trial. Serious adverse events and other adverse events are reported for all participants who received at least one dose of IP.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    49
    description
    Participants with relapsed or refractory multiple myeloma received a triplet combination of KRd. Carfilzomib was administered as a 10-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, escalated to a target dose of 27 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. From cycle 13, the Day 8 and Day 9 doses of carfilzomib were omitted. After cycle 18, carfilzomib was discontinued. Lenalidomide 25 mg was taken orally on Days 1 to 21 and dexamethasone 40 mg by mouth or IV infusion on Days 1, 8, 15, and 22 of repeated 28-day treatment cycles.
    id
    EG000
    other Num Affected
    45
    other Num At Risk
    49
    serious Num Affected
    11
    serious Num At Risk
    49
    title
    Carfilzomib, Lenalidomide and Dexamethasone (KRd)
  2. deaths Num Affected
    2
    deaths Num At Risk
    52
    description
    Participants with relapsed or refractory multiple myeloma received a doublet combination of Kd. Carfilzomib was administered as a 30-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day treatment cycles. The starting dose of carfilzomib was 20 mg/m\^2 on Days 1 and 2, and if tolerated, was escalated to a target dose of 56 mg/m\^2 starting on Day 8 of cycle 1 and thereafter. Dexamethasone 20 mg was taken by mouth or intravenously on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
    id
    EG001
    other Num Affected
    42
    other Num At Risk
    52
    serious Num Affected
    20
    serious Num At Risk
    52
    title
    Carfilzomib and Dexamethasone (Kd)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      52
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      52
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      52
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      52
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      52
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      52
    term
    Oedema peripheral
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      52
    term
    Pyrexia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Thrombotic microangiopathy
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Acute cardiac event
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Cardiac arrest
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      52
    term
    Cardiac failure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Cardiotoxicity
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Visual impairment
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Diarrhoea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Neutropenic colitis
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      52
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Amoebic dysentery
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 28.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      49
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      52
    term
    Bronchitis
time Frame
For all-cause mortality reporting, from enrollment until the end of trial or death date, whichever occurred earlier; median (min, max) time on trial was 8.7 (0.1, 37.2) months. For Adverse Event reporting, from the first dose date of any IP until the end of trial; median (min, max) time on trial was 8.7 (0.1, 37.2) months.

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