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NCT04649060 · ADVERSE EVENTS

Adverse events

Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma · Source last updated 2023-06-08

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
Adverse events (AEs) were collected from the start of study treatment until 30 days after the last dose of study drug or initiation of subsequent therapy whichever occurred first. Serious AEs (SAEs) were collected from signing of the informed consent form (ICF) until 30 days after the last dose of study treatment or initiation of subsequent therapy whichever occurred first. The maximum duration of treatment was 48 weeks, and the maximum duration of AEs/SAEs collection was 48 weeks + 30 days.
Other-event reporting threshold
5%

AE definition: An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are grouped by MedDRA system organ class (SOC) and preferred term (PT).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A (Melflufen+Dexamethasone+Daratumumab)

Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7

6 / 2221 / 222 / 22
Arm B (Daratumumab)

Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7

12 / 2622 / 263 / 26
Crossover (From Arm B to the Same Treatment as Arm A)

Patients in Arm B were allowed to crossover and receive the same treatment as Arm A after a confirmed disease progression (2 patients crossed over).

1 / 22 / 21 / 2

Group identifiers: EG000: Arm A (Melflufen+Dexamethasone+Daratumumab) · EG001: Arm B (Daratumumab) · EG002: Crossover (From Arm B to the Same Treatment as Arm A)

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
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Asymptomatic COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    COVID-19 pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Enterocolitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Gingival bleeding
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Rectal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Disease progression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Femur fracture

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
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Neutrophil count decrease
Complete source fields
description
AE definition: An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs are grouped by MedDRA system organ class (SOC) and preferred term (PT).
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    22
    description
    Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
    id
    EG000
    other Num Affected
    21
    other Num At Risk
    22
    serious Num Affected
    6
    serious Num At Risk
    22
    title
    Arm A (Melflufen+Dexamethasone+Daratumumab)
  2. deaths Num Affected
    3
    deaths Num At Risk
    26
    description
    Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
    id
    EG001
    other Num Affected
    22
    other Num At Risk
    26
    serious Num Affected
    12
    serious Num At Risk
    26
    title
    Arm B (Daratumumab)
  3. deaths Num Affected
    1
    deaths Num At Risk
    2
    description
    Patients in Arm B were allowed to crossover and receive the same treatment as Arm A after a confirmed disease progression (2 patients crossed over).
    id
    EG002
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    1
    serious Num At Risk
    2
    title
    Crossover (From Arm B to the Same Treatment as Arm A)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Pneumonia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Infection
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Upper respiratory tract infection
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Lymphopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Pyrexia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Neutrophil count decrease
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Pancytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
    term
    Pneumonia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Asymptomatic COVID-19
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    COVID-19 pneumonia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Enterocolitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Gingival bleeding
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Rectal haemorrhage
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Death
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Disease progression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      22
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
    term
    Femur fracture
time Frame
Adverse events (AEs) were collected from the start of study treatment until 30 days after the last dose of study drug or initiation of subsequent therapy whichever occurred first. Serious AEs (SAEs) were collected from signing of the informed consent form (ICF) until 30 days after the last dose of study treatment or initiation of subsequent therapy whichever occurred first. The maximum duration of treatment was 48 weeks, and the maximum duration of AEs/SAEs collection was 48 weeks + 30 days.

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