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NCT01239368 · OUTCOME

Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Date treatment consent signed to last date off study, 81 months and 6 days

What was measured

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Analysis population: 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.

Groups in this outcome

Cohort 1 - 1x10(5) T Cells/kg

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

Cohort 2 - 5x10(5) T Cells/kg

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

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

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

Cohort 4 - 3x10(6) T Cells/kg

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

Cohort 5 - 5x10(6) T Cells/kg

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

Cohort 5B - 5x10(6) T Cells/kg

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

Cohort 6 - 15x10(6) T Cells/kg

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

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

45x10(6) th1 cells/kg of body weight

Cohort A - Th1/Tc1.Rapa Prevention of Relapse

Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1.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

Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma

Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1.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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1 - 1x10(5) T Cells/kg2
Cohort 2 - 5x10(5) T Cells/kg1
Cohort 3 - 1x10(6) T Cells/kg1
Cohort 4 - 3x10(6) T Cells/kg2
Cohort 5 - 5x10(6) T Cells/kg7
Cohort 5B - 5x10(6) T Cells/kg5
Cohort 6 - 15x10(6) T Cells/kg7
Cohort 7 - 45x10(6) T Cells/kg0
Cohort A - Th1/Tc1.Rapa Prevention of Relapse1
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 - 1x10(5) T Cells/kg1Not reportedNot reportedNot reportedNot reported
Cohort 2 - 5x10(5) T Cells/kg1Not reportedNot reportedNot reportedNot reported
Cohort 3 - 1x10(6) T Cells/kg1Not reportedNot reportedNot reportedNot reported
Cohort 4 - 3x10(6) T Cells/kg2Not reportedNot reportedNot reportedNot reported
Cohort 5 - 5x10(6) T Cells/kg5Not reportedNot reportedNot reportedNot reported
Cohort 5B - 5x10(6) T Cells/kg2Not reportedNot reportedNot reportedNot reported
Cohort 6 - 15x10(6) T Cells/kg3Not reportedNot reportedNot reportedNot reported
Cohort 7 - 45x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort A - Th1/Tc1.Rapa Prevention of Relapse1Not reportedNot reportedNot reportedNot reported
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        5
      6. group Id
        OG005
        value
        2
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        1
      10. group Id
        OG009
        value
        4
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    7. group Id
      OG006
      value
      7
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      1
    10. group Id
      OG009
      value
      5
    units
    Participants
description
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
groups
  1. description
    1x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG000
    title
    Cohort 1 - 1x10(5) T Cells/kg
  2. description
    5x10(5) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG001
    title
    Cohort 2 - 5x10(5) T Cells/kg
  3. description
    1x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG002
    title
    Cohort 3 - 1x10(6) T Cells/kg
  4. description
    3x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG003
    title
    Cohort 4 - 3x10(6) T Cells/kg
  5. description
    5x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG004
    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
    OG005
    title
    Cohort 5B - 5x10(6) T Cells/kg
  7. description
    15x10(6) Th1/Tc1.Rapa cells/kg of body weight
    id
    OG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) th1 cells/kg of body weight
    id
    OG007
    title
    Cohort 7 - 45x10(6) T Cells/kg
  9. description
    Th1/Tc1.Rapa Prevention of Relapse Adoptive Immunotherapy: Th1.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
    OG008
    title
    Cohort A - Th1/Tc1.Rapa Prevention of Relapse
  10. description
    Th1/Tc1.Rapa for Relapsed Multiple Myeloma Adoptive Immunotherapy: Th1.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
    OG009
    title
    Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma
param Type
COUNT_OF_PARTICIPANTS
population 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.
reporting Status
POSTED
time Frame
Date treatment consent signed to last date off study, 81 months and 6 days
title
Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice