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NCT01239368 · FLOW

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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.

groups
  1. description
    1x10(5) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG000
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. description
    5x10(5) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG001
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. description
    1x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG002
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. description
    3x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG003
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. description
    5x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG004
    title
    Cohort 5 - 5x10(6) T Cells/kg
  6. description
    5x10(6) Th1/Tc1 Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
    id
    FG005
    title
    Cohort 5B - 5x10(6) T Rapa Cells/kg
  7. description
    15x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG007
    title
    Cohort 7 - 45x10(6) T Cells/kg of
  9. 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 Rapa 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
    FG008
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. 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
    FG009
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Principal investigator discretion
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      type
      Disease progression on study
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Refused further treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
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 max. number that could be manufactured due to limiting reagents for cell culture. 3/34 pts signed consent but did not receive therapy due to progressive malignancy.
Complete source fields
groups
  1. description
    1x10(5) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG000
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. description
    5x10(5) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG001
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. description
    1x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG002
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. description
    3x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG003
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. description
    5x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG004
    title
    Cohort 5 - 5x10(6) T Cells/kg
  6. description
    5x10(6) Th1/Tc1 Rapa cells/kg of body weight; Three sequential infusions with at least two months between infusions.
    id
    FG005
    title
    Cohort 5B - 5x10(6) T Rapa Cells/kg
  7. description
    15x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) Th1/Tc1 Rapa cells/kg of body weight
    id
    FG007
    title
    Cohort 7 - 45x10(6) T Cells/kg of
  9. 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 Rapa 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
    FG008
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. 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
    FG009
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Principal investigator discretion
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      type
      Disease progression on study
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      type
      Refused further treatment
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        7
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        7
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        1
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
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 max. number that could be manufactured due to limiting reagents for cell culture. 3/34 pts signed consent but did not receive therapy due to progressive malignancy.

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Preserved source evidence · Not medical advice