Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03525678 · OUTCOME

Number of Participants With Grade Change From Baseline in Hematology Parameters

A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03

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
Baseline (Day 1) and Up to 186 weeks

What was measured

Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.

Analysis population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.

Groups in this outcome

Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)

Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.

Main Study: GSK2857916 3.4 mg/kg (Lyophilized)

Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.

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

Analysis denominator · Participants

GroupSource count
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)95
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)97
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)24

Reported measurements

Hb, Hb increased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Hb, Hb increased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Hb, Anemia, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)19Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)30Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)5Not reportedNot reportedNot reportedNot reported
Hb, Anemia, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count increased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count increased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count decreased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)16Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)24Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)6Not reportedNot reportedNot reportedNot reported
Lymph, Lymph count decreased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)2Not reportedNot reportedNot reportedNot reported
Neutro, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)4Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)10Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)2Not reportedNot reportedNot reportedNot reported
Neutro, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)6Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)3Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)1Not reportedNot reportedNot reportedNot reported
PC, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)9Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)11Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)1Not reportedNot reportedNot reportedNot reported
PC, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)13Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)25Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)2Not reportedNot reportedNot reportedNot reported
Leuko, Leukocytosis, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Leuko, Leukocytosis, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)0Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not reportedNot reportedNot reportedNot reported
Leuko, Leuko decreased, increase to Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)5Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)9Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)2Not reportedNot reportedNot reportedNot reported
Leuko, Leuko decreased, increase to Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)3Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)3Not reportedNot reportedNot reportedNot reported
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)0Not 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
    title
    Hb, Hb increased, increase to Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hb, Hb increased, increase to Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        30
      3. group Id
        OG002
        value
        5
    title
    Hb, Anemia, increase to Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Hb, Anemia, increase to Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Lymph, Lymph count increased, increase to Grade 3
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Lymph, Lymph count increased, increase to Grade 4
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        16
      2. group Id
        OG001
        value
        24
      3. group Id
        OG002
        value
        6
    title
    Lymph, Lymph count decreased, increase to Grade 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        2
    title
    Lymph, Lymph count decreased, increase to Grade 4
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        2
    title
    Neutro, increase to Grade 3
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
    title
    Neutro, increase to Grade 4
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
      3. group Id
        OG002
        value
        1
    title
    PC, increase to Grade 3
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        25
      3. group Id
        OG002
        value
        2
    title
    PC, increase to Grade 4
denoms
  1. counts
    1. group Id
      OG000
      value
      95
    2. group Id
      OG001
      value
      97
    3. group Id
      OG002
      value
      24
    units
    Participants
description
Blood samples were collected for the analysis of following hematology parameters: hemoglobin (Hb), lymphocyte count (Lymph), neutrophil count (Neutro), platelet count (PC), and leukocyte count (leuko). The laboratory parameters were graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. An increase is defined as an increase in CTCAE grade relative to Baseline grade. Data for worst-case post Baseline is presented. Only those participants with increase to grade 3 and increase to grade 4 have been presented.
groups
  1. description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
    id
    OG000
    title
    Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
  2. description
    Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
    id
    OG001
    title
    Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
  3. description
    Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
    id
    OG002
    title
    Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
reporting Status
POSTED
time Frame
Baseline (Day 1) and Up to 186 weeks
title
Number of Participants With Grade Change From Baseline in Hematology Parameters
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice