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NCT02148913 · ADVERSE EVENTS

Adverse events

Phase I: Melphalan, Bendamustine and Carfilzomib for Autologous Transplant in Multiple Myeloma · Source last updated 2024-07-26

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
CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).
Other-event reporting threshold
0%

CTCAE v4.0

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Carfilzomib 15 mg/m2

Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6

0 / 33 / 30 / 3
Cohort 2: Carfilzomib 20 mg/m2

Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6

2 / 33 / 31 / 3
Cohort 2b: Carfilzomib 20 mg/m2

Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5

0 / 33 / 30 / 3
Cohort 3: Carfilzomib 27mgm2

Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5

0 / 99 / 90 / 9

Group identifiers: EG000: Cohort 1: Carfilzomib 15 mg/m2 · EG001: Cohort 2: Carfilzomib 20 mg/m2 · EG002: Cohort 2b: Carfilzomib 20 mg/m2 · EG003: Cohort 3: Carfilzomib 27mgm2

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
    notes
    developed grade 4 acute respiratory distress, grade 3 prolonged intubation, and grade 3 pneumonia. deteriorated neurologically and subsequently was shown to have experienced a brain hemorrhage and expired on day +44
    organ System
    Respiratory, thoracic and mediastinal 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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acute Respiratory Distress
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    developed grade 4 febrile neutropenia, and several grade 3 events secondary to septic shock (grade 3 elevated troponin T, grade 3 hypotension, and grade 3 left ventricular dysfunction) from Escherichia coli enteritis.
    organ System
    Infections and infestations
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Septic Shock

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      9
      num Events
      6
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal 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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    mucositis/esophagitis
  6. 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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    enteritis
  7. 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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    small bowel obstruction
  8. 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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    partial ileus
  9. 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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    hematochezia
  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
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    hemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    hypophosphatemia
  12. 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
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    hypocalcemia
Complete source fields
description
CTCAE v4.0
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Carfilzomib 15 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 1: Carfilzomib 15 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
    id
    EG000
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Cohort 1: Carfilzomib 15 mg/m2
  2. deaths Num Affected
    1
    deaths Num At Risk
    3
    description
    Carfilzomib 20 mg/m2 on days -2, -1, +5, and +6 IV over 10 minutes. Cohort 2: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
    id
    EG001
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    2
    serious Num At Risk
    3
    title
    Cohort 2: Carfilzomib 20 mg/m2
  3. deaths Num Affected
    0
    deaths Num At Risk
    3
    description
    Carfilzomib 20 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 2b: Carfilzomib 20 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
    id
    EG002
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    0
    serious Num At Risk
    3
    title
    Cohort 2b: Carfilzomib 20 mg/m2
  4. deaths Num Affected
    0
    deaths Num At Risk
    9
    description
    Carfilzomib 27 mg/m2 on days -2, -1 and +5 IV over 10 minutes. Cohort 3b: Carfilzomib 27 mg/m2: Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
    id
    EG003
    other Num Affected
    9
    other Num At Risk
    9
    serious Num Affected
    0
    serious Num At Risk
    9
    title
    Cohort 3: Carfilzomib 27mgm2
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      3
      num Events
      2
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      9
      num Events
      6
    term
    Diarrhea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Nausea
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      3
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Vomiting
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal 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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      3
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    mucositis/esophagitis
  6. 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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    enteritis
  7. 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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    small bowel obstruction
  8. 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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      3
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    partial ileus
  9. 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
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    hematochezia
  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
      0
      num At Risk
      3
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      9
      num Events
      1
    term
    hemorrhoids
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      3
      num Events
      3
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      3
      num Events
      3
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    hypophosphatemia
  12. 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
      2
      num At Risk
      3
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    hypocalcemia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    developed grade 4 acute respiratory distress, grade 3 prolonged intubation, and grade 3 pneumonia. deteriorated neurologically and subsequently was shown to have experienced a brain hemorrhage and expired on day +44
    organ System
    Respiratory, thoracic and mediastinal 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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Acute Respiratory Distress
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    developed grade 4 febrile neutropenia, and several grade 3 events secondary to septic shock (grade 3 elevated troponin T, grade 3 hypotension, and grade 3 left ventricular dysfunction) from Escherichia coli enteritis.
    organ System
    Infections and infestations
    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
      3
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      3
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      9
      num Events
      0
    term
    Septic Shock
time Frame
CBC, CMP, BUN, creatinine labs, and LFT were then measured at least weekly until day +100. Daily physical examination, including toxicity assessments were conducted until discharge and then weekly until day +100. Disease assessments were conducted at day +100, +180, and +365 (+/- 7 days).

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