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NCT01239368 · ADVERSE EVENTS

Adverse events

Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma · Source last updated 2019-12-10

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
Date treatment consent signed to last date off study, 81 months and 6 days.
Other-event reporting threshold
0%

For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1 - 1x10(5) T Cells/kg

1x10(5) Th1/Tc1.Rapa cells/kg of body weight

0 / 21 / 20 / 2
Cohort 2 - 5x10(5) T Cells/kg

5x10(5) Th1/Tc1.Rapa cells/kg of body weight

0 / 11 / 10 / 1
Cohort 3 - 1x10(6) T Cells/kg

1x10(6) Th1/Tc1.Rapa cells/kg of body weight

0 / 11 / 10 / 1
Cohort 4 - 3x10(6) T Cells/kg

3x10(6) Th1/Tc1.Rapa cells/kg of body weight

0 / 22 / 20 / 2
Cohort 5 - 5x10(6) T Cells/kg

5x10(6) Th1/Tc1.Rapa cells/kg of body weight

1 / 75 / 70 / 7
Cohort 5B - 5x10(6) T Rapa Cells/kg

5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.

0 / 52 / 50 / 5
Cohort 6 - 15x10(6) T Cells/kg

15x10(6) Th1/Tc1.Rapa cells/kg of body weight

1 / 73 / 71 / 7
Cohort 7 - 45x10(6) T Cells/kg

45x10(6) Th1/Tc1.Rapa cells/kg of body weight

0 / 00 / 00 / 0
Cohort A - Th1/Tc1.Rapa Prevention of Relapse

Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg

0 / 11 / 10 / 1
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma

Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg

1 / 54 / 50 / 5

Group identifiers: EG000: Cohort 1 - 1x10(5) T Cells/kg · EG001: Cohort 2 - 5x10(5) T Cells/kg · EG002: Cohort 3 - 1x10(6) T Cells/kg · EG003: Cohort 4 - 3x10(6) T Cells/kg · EG004: Cohort 5 - 5x10(6) T Cells/kg · EG005: Cohort 5B - 5x10(6) T Rapa Cells/kg · EG006: Cohort 6 - 15x10(6) T Cells/kg · EG007: Cohort 7 - 45x10(6) T Cells/kg · EG008: Cohort A - Th1/Tc1.Rapa Prevention of Relapse · EG009: Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma

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
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Intracranial hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Heart failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Progressive disease
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Death

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
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Alkaline phosphatase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypomagnesemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypophosphatemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      10
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      7
      num Events
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    CPK increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Blood bilirubin increased
Complete source fields
description
For the planned protocol cohort 7, no patients were accrued due to lack of feasibility in terms of T cell manufacturing. That is, cohort 6 evaluated 15X10EE6 cells per kg, which was the maximum number that could be manufactured due to limiting reagents for cell culture.
event Groups
  1. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    1x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG000
    other Num Affected
    1
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    5x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG001
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    1x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG002
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. deaths Num Affected
    0
    deaths Num At Risk
    2
    description
    3x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG003
    other Num Affected
    2
    other Num At Risk
    2
    serious Num Affected
    0
    serious Num At Risk
    2
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. deaths Num Affected
    0
    deaths Num At Risk
    7
    description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG004
    other Num Affected
    5
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Cohort 5 - 5x10(6) T Cells/kg
  6. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
    id
    EG005
    other Num Affected
    2
    other Num At Risk
    5
    serious Num Affected
    0
    serious Num At Risk
    5
    title
    Cohort 5B - 5x10(6) T Rapa Cells/kg
  7. deaths Num Affected
    1
    deaths Num At Risk
    7
    description
    15x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG006
    other Num Affected
    3
    other Num At Risk
    7
    serious Num Affected
    1
    serious Num At Risk
    7
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. deaths Num Affected
    0
    deaths Num At Risk
    0
    description
    45x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    EG007
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Cohort 7 - 45x10(6) T Cells/kg
  9. deaths Num Affected
    0
    deaths Num At Risk
    1
    description
    Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Rapamycin-Generated Autologous Th1/Tc1 Cells: Six Th1.rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight. Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
    id
    EG008
    other Num Affected
    1
    other Num At Risk
    1
    serious Num Affected
    0
    serious Num At Risk
    1
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. deaths Num Affected
    0
    deaths Num At Risk
    5
    description
    Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1/Tc1.Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen). Th1/TC1 Rapa Cell Therapy: Th1/TC1rapa: 5 x 10e(6) cells/kg
    id
    EG009
    other Num Affected
    4
    other Num At Risk
    5
    serious Num Affected
    1
    serious Num At Risk
    5
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Alkaline phosphatase increased
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      2
    5. group Id
      EG004
      num Affected
      3
      num At Risk
      7
      num Events
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      5
      num Events
      1
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Anemia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Aspartate aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypomagnesemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      4
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Hypophosphatemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Lung infection
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      4
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      7
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      3
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      2
      num Events
      3
    5. group Id
      EG004
      num Affected
      2
      num At Risk
      7
      num Events
      10
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
      num Events
      3
    7. group Id
      EG006
      num Affected
      2
      num At Risk
      7
      num Events
      2
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    Neutrophil count decreased
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      7
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      1
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Platelet count decreased
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      2
      num Events
      9
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      1
      num Events
      2
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      4
      num At Risk
      7
      num Events
      7
    6. group Id
      EG005
      num Affected
      2
      num At Risk
      5
      num Events
      5
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      2
      num At Risk
      5
      num Events
      2
    term
    White blood cell decreased
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      1
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    CPK increased
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Back pain
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Blood bilirubin increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Intracranial hemorrhage
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      1
      num At Risk
      5
      num Events
      1
    term
    Heart failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      7
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      7
      num Events
      0
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Sepsis
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Progressive disease
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      2
      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
      1
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      2
      num Events
      0
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      7
      num Events
      0
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      5
      num Events
      0
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      7
      num Events
      1
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      0
      num Events
      0
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      1
      num Events
      0
    10. group Id
      EG009
      num Affected
      0
      num At Risk
      5
      num Events
      0
    term
    Death
time Frame
Date treatment consent signed to last date off study, 81 months and 6 days.

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Preserved source evidence · Not medical advice