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NCT01239368 · OUTCOME

Number of Patients With an Adverse Event Attributable to the Investigational Therapy

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
2 months

What was measured

Participants were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

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.Rapac ells/kg of body weight

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

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

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/Tc1.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/Tc1.Rapa 5 x 10e(6) cells/kg

Cohort B - Th1/Tc1.Rapa Prevention of Relapse

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/Tc1.Rapa: 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 Prevention of Relapse5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 - 1x10(5) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 2 - 5x10(5) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 3 - 1x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 4 - 3x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 5 - 5x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 5B - - 5x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 6 - 15x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort 7- 45x10(6) T Cells/kg0Not reportedNot reportedNot reportedNot reported
Cohort A - Th1/Tc1.Rapa Prevention of Relapse0Not reportedNot reportedNot reportedNot reported
Cohort B - Th1/Tc1.Rapa Prevention of Relapse0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
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
Participants were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
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.Rapac ells/kg of body weight
    id
    OG006
    title
    Cohort 6 - 15x10(6) T Cells/kg
  8. description
    45x10(6) Th1/Tc1.Rapa 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/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/Tc1.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/Tc1.Rapa 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/Tc1.Rapa: 5 x 10e(6) cells/kg
    id
    OG009
    title
    Cohort B - Th1/Tc1.Rapa Prevention of Relapse
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
2 months
title
Number of Patients With an Adverse Event Attributable to the Investigational Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice