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NCT01995708 · ADVERSE EVENTS

Adverse events

CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation · Source last updated 2024-02-09

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
1 year
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm 1 Vaccine

This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical \& Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10\^6 LCs per dose (i.e., combination of 3x10\^6 CT7 mRNA-electroporated LCs + 3x10\^6 MAGE-A3 mRNA-electroporated LCs + 3x10\^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression. CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs): Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10\^6 LCs per vaccine x 3.

3 / 1313 / 1312 / 13
Arm 2 Control

Patients receive standard of care treatment after autologous stem cell transplant Standard of care: No vaccines

2 / 1515 / 158 / 15

Group identifiers: EG000: Arm 1 Vaccine · EG001: Arm 2 Control

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
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Cough
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Resp, thoracic & mediastinal disorder Other, spec
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Lung infection

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
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hyperglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypocalcemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
    term
    Hypophosphatemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      15
    term
    Lymphocyte count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      15
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      15
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      15
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Rash maculo-papular
Complete source fields
event Groups
  1. deaths Num Affected
    12
    deaths Num At Risk
    13
    description
    This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical \& Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10\^6 LCs per dose (i.e., combination of 3x10\^6 CT7 mRNA-electroporated LCs + 3x10\^6 MAGE-A3 mRNA-electroporated LCs + 3x10\^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression. CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs): Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10\^6 LCs per vaccine x 3.
    id
    EG000
    other Num Affected
    13
    other Num At Risk
    13
    serious Num Affected
    3
    serious Num At Risk
    13
    title
    Arm 1 Vaccine
  2. deaths Num Affected
    8
    deaths Num At Risk
    15
    description
    Patients receive standard of care treatment after autologous stem cell transplant Standard of care: No vaccines
    id
    EG001
    other Num Affected
    15
    other Num At Risk
    15
    serious Num Affected
    2
    serious Num At Risk
    15
    title
    Arm 2 Control
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      15
    term
    Anemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hyperglycemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypocalcemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hyponatremia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      15
    term
    Hypophosphatemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      15
    term
    Lymphocyte count decreased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      15
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      15
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      15
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Lung infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Rash maculo-papular
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Abdominal pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Atrial fibrillation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Cough
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Dehydration
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      15
    term
    Resp, thoracic & mediastinal disorder Other, spec
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Catheter related infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Hypertension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      13
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      15
    term
    Lung infection
time Frame
1 year

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Preserved source evidence · Not medical advice