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NCT03168438 · OUTCOME

Number of Participants With Worst-case Chemistry Results by Any Grade Increase Post-Baseline Relative to Baseline

Letetresgene Autoleucel Engineered T Cells Alone and in Combination With Pembrolizumab in NY-ESO-1 Positive Multiple Myeloma · Source last updated 2022-01-11

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
Up to 108 weeks

What was measured

Blood samples were collected for the assessment of following clinical chemistry parameters: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, phosphate, sodium and calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case post Baseline is presented.

Analysis population: Modified ITT Population comprised of all participants in the ITT Population who received the NY-ESO-1c259T infusion.

Groups in this outcome

GSK3377794

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.

GSK3377794+Pembrolizumab

Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.

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

Analysis denominator · Participants

GroupSource count
GSK33777943
GSK3377794+Pembrolizumab3

Reported measurements

Glucose (Hyperglycemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777942Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab2Not reportedNot reportedNot reportedNot reported
Glucose (Hypoglycemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Albumin (Hypoalbuminemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777943Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab2Not reportedNot reportedNot reportedNot reported
ALP increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777941Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab1Not reportedNot reportedNot reportedNot reported
ALT increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab1Not reportedNot reportedNot reportedNot reported
AST increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Bilirubin increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Creatinine increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777941Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab3Not reportedNot reportedNot reportedNot reported
Potassium (Hyperkalemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Potassium (Hypokalemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777941Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab2Not reportedNot reportedNot reportedNot reported
Magnesium (Hypermagnesemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Magnesium (Hypomagnesemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777942Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Phosphate (Hypophosphatemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777942Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab2Not reportedNot reportedNot reportedNot reported
Sodium (Hypernatremia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777940Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Sodium (Hyponatremia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777942Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab1Not reportedNot reportedNot reportedNot reported
Calcium (Hypercalcemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777941Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab0Not reportedNot reportedNot reportedNot reported
Calcium (Hypocalcemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
GSK33777942Not reportedNot reportedNot reportedNot reported
GSK3377794+Pembrolizumab3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Glucose (Hyperglycemia)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Glucose (Hypoglycemia)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Albumin (Hypoalbuminemia)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    ALP increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    ALT increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    AST increased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Bilirubin increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
    title
    Creatinine increased
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Potassium (Hyperkalemia)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    Potassium (Hypokalemia)
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Magnesium (Hypermagnesemia)
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Magnesium (Hypomagnesemia)
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
Blood samples were collected for the assessment of following clinical chemistry parameters: glucose, albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, phosphate, sodium and calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst case post Baseline is presented.
groups
  1. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of GSK3377794.
    id
    OG000
    title
    GSK3377794
  2. description
    Eligible participants underwent leukapheresis to manufacture engineered T-cells. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single IV infusion of GSK3377794 in combination with pembrolizumab 200 milligrams (mg) administered as an IV infusion every 3 weeks up to Week 108.
    id
    OG001
    title
    GSK3377794+Pembrolizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Modified ITT Population comprised of all participants in the ITT Population who received the NY-ESO-1c259T infusion.
reporting Status
POSTED
time Frame
Up to 108 weeks
title
Number of Participants With Worst-case Chemistry Results by Any Grade Increase Post-Baseline Relative to Baseline
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice