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NCT06160609 · OUTCOME

CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters

Platform Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With aOX40 (GSK3174998) in Participants With RRMM · Source last updated 2024-03-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Up to 170 weeks

What was measured

Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.

Analysis population: Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 8mg OX40

Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.

2.5 mg/kg Belantamab Mafodotin + 8mg OX40

Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.

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

Analysis denominator · Participants

GroupSource count
1.9 mg/kg Belantamab Mafodotin + 8mg OX400
2.5 mg/kg Belantamab Mafodotin + 8mg OX400

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Blood samples were collected for the analysis of following chemistry parameters: Hypoglycemia, hypoalbuminemia, alkaline phosphatase (ALP) increased, alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, blood bilirubin increased, creatine kinase (CPK) increased, creatinine increased, gamma glutamyl transferase (GGT) increased, hyperkalemia, blood lactate dehydrogenase (LDH) increased, hypermagnesemia, hypomagnesemia, hypernatremia, hypercalcemia, hypocalcemia and chronic kidney disease. The laboratory parameters were graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade.
groups
  1. description
    Participants with RRMM received 1.9 milligram (mg)/kilogram (kg) belantamab mafodotin intravenous (IV) infusion as powder for solution once every 3 weeks (Q3W) infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles.
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 8mg OX40
  2. description
    Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion as powder for solution Q3W infused over 30- 60 minutes on day 1 of 21-day cycles in combination with 8 mg OX40 IV solution 1 hour after belantamab mafodotin EOI on day 1 of 21-day cycles.
    id
    OG001
    title
    2.5 mg/kg Belantamab Mafodotin + 8mg OX40
population Description
Safety Population included all participants who received at least 1 dose of any component of the combination therapy. No participants were enrolled in CE Phase as study got terminated.
reporting Status
POSTED
time Frame
Up to 170 weeks
title
CE Phase: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters
type
SECONDARY

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

Preserved source evidence · Not medical advice