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NCT02215967 · OUTCOME

Number of Participants With Dose Limiting Toxicities

Study of T Cells Targeting B-Cell Maturation Antigen for Previously Treated Multiple Myeloma · Source last updated 2019-10-08

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
After the start of treatment and up to 60 days

What was measured

Dose limiting toxicities are defined as follows: Grade 3 toxicities possibly or probably related to either the anti-BCMA CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.

Analysis population: One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.

Groups in this outcome

0.3 x 10^6 CAR-BCMA T-cells Infused

Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0

1 x 10^6 CAR-BCMA T-cells Infused

Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0

3 x 10^6 CAR-BCMA T-cells Infused

Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0

9 x 10^6 CAR-BCMA T-cells Infused

Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0

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

Analysis denominator · Participants

GroupSource count
0.3 x 10^6 CAR-BCMA T-cells Infused3
1 x 10^6 CAR-BCMA T-cells Infused3
3 x 10^6 CAR-BCMA T-cells Infused4
9 x 10^6 CAR-BCMA T-cells Infused16

Reported measurements

Hypophosphatemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Confusion
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Dyspnea (intubated)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Ejection fraction decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Encephalopathy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Hypoxia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Acute kidney injury (CVVH)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Sepsis (Staph Aureus)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Muscle weakness lower limbs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Muscle weakness upper limbs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Platelet count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Neutrophil count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Acute kidney injury
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not reportedNot reportedNot reportedNot reported
Hypotension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
CPK increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused4Not reportedNot reportedNot reportedNot reported
Musculoskeletal/connective tissue disorders-Rhabd.
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
0.3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
1 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
3 x 10^6 CAR-BCMA T-cells Infused0Not reportedNot reportedNot reportedNot reported
9 x 10^6 CAR-BCMA T-cells Infused3Not 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
        4
    title
    Hypophosphatemia
  2. 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
        3
    title
    Confusion
  3. 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
        4
    title
    Dyspnea (intubated)
  4. 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
        4
    title
    Ejection fraction decreased
  5. 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
        3
    title
    Encephalopathy
  6. 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
        3
    title
    Hypoxia
  7. 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
        4
    title
    Acute kidney injury (CVVH)
  8. 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
        4
    title
    Sepsis (Staph Aureus)
  9. 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
        3
    title
    Muscle weakness lower limbs
  10. 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
        3
    title
    Muscle weakness upper limbs
  11. 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
        3
    title
    Platelet count decreased
  12. 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
        4
    title
    Neutrophil count decreased
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      16
    units
    Participants
description
Dose limiting toxicities are defined as follows: Grade 3 toxicities possibly or probably related to either the anti-BCMA CAR T cells or the fludarabine and cyclophosphamide chemotherapy and lasting more than 7 days. Grade 4 toxicities possibly or probably related to the study interventions.
groups
  1. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    OG000
    title
    0.3 x 10^6 CAR-BCMA T-cells Infused
  2. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    OG001
    title
    1 x 10^6 CAR-BCMA T-cells Infused
  3. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    OG002
    title
    3 x 10^6 CAR-BCMA T-cells Infused
  4. description
    Dose Escalation with 5 dose levels based on the patients actual bodyweight Cyclophosphamide: 300 mg/m\^2 intravenous (IV) over 30 minutes on days -5, -4, and -3 Fludarabine: 30 mg/m\^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells: 0.3x10\^6- 15.0x10\^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
    id
    OG003
    title
    9 x 10^6 CAR-BCMA T-cells Infused
param Type
COUNT_OF_PARTICIPANTS
population Description
One participant in Group 9x10(6) did not get CAR T-cells and was deemed ineligible, and 3 participants in Group 9x10(6) were found to be ineligible for treatment.
reporting Status
POSTED
time Frame
After the start of treatment and up to 60 days
title
Number of Participants With Dose Limiting Toxicities
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice