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NCT03440411 · ADVERSE EVENTS

Adverse events

Pom-dex Versus Pom-Cyclo-dex in MM Patients With Biochemical or Clinical Relapse, During Lena Maintenance Treatment · Source last updated 2021-03-10

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
from randomization through study completion, up to 57 months, an average of 45 months
Other-event reporting threshold
0%

In the table "Other Adverse Events" each term reports ae term\_ctcae grade

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
ARM Pom-dex Early (A-I)

Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

1 / 32 / 31 / 3
ARM Pom-dex Late (A-II)

Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

0 / 11 / 11 / 1
ARM Pom-cyclo-dex Early (B-I)

Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

0 / 21 / 20 / 2
ARM Pom-cyclo-dex Late (B-II)

Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance

0 / 22 / 20 / 2

Group identifiers: EG000: ARM Pom-dex Early (A-I) · EG001: ARM Pom-dex Late (A-II) · EG002: ARM Pom-cyclo-dex Early (B-I) · EG003: ARM Pom-cyclo-dex Late (B-II)

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
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acute renal failure

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
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Agitation_1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Agitation_2
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Agitation_3
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    ALT increased_2
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anemia_1
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    AST increased_1
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Bronchial infection_2
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Chills_1
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Confusion_2
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation_1
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Diarrhea_2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Erythema multiforme_2
Complete source fields
description
In the table "Other Adverse Events" each term reports ae term\_ctcae grade
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Patients will receive treatment at biochemical relapse with pom-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    EG000
    other Num Affected
    2
    other Num At Risk
    3
    serious Num Affected
    1
    serious Num At Risk
    3
    title
    ARM Pom-dex Early (A-I)
  2. deaths Num Affected
    1
    deaths Num At Risk
    1
    description
    Patients will be randomized at biochemical relapse and they will start treatment with pom-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    ARM Pom-dex Late (A-II)
  3. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Patients will receive treatment at biochemical relapse with pom-cyclo-dex Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    ARM Pom-cyclo-dex Early (B-I)
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    Patients will be randomized at biochemical relapse and they will start treatment with pom-cyclo-dex at the onset of CRAB symptoms/significant paraprotein increase. Pomalidomide: 4 mg/daily as oral administration (PO) on days 1-21. Cyclophosphamide: 50 mg every other day as oral administration (PO) on days 1-28 Dexamethasone: 40 mg as oral administration (PO) on days 1, 8, 15, 22. For 28-day cycles until progression or intolerance
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    ARM Pom-cyclo-dex Late (B-II)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Agitation_1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Agitation_2
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Agitation_3
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    ALT increased_2
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Anemia_1
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    AST increased_1
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Bronchial infection_2
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Chills_1
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Confusion_2
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Constipation_1
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      2
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Diarrhea_2
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      3
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      1
    term
    Erythema multiforme_2
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      2
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    term
    Acute renal failure
time Frame
from randomization through study completion, up to 57 months, an average of 45 months

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Preserved source evidence · Not medical advice