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NCT06655818 · OUTCOME

DE Phase: Concentration of ADAs Against Belantamab Mafodotin

Sub-study of Belantamab Mafodotin (GSK2857916) as Monotherapy and in Combination With Dostarlimab (GSK4057190) in Participants With RRMM · Source last updated 2025-03-03

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Up to 153 weeks

What was measured

Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.

Analysis population: Safety Population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.

Groups in this outcome

1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab

Participants with Relapsed/Refractory Multiple Myeloma (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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).

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 + 500mg Dostarlimab1

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin + 500mg DostarlimabNANANot reportedNot reportedData was not estimable for 1 participant as the values were below the level of detection
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data was not estimable for 1 participant as the values were below the level of detection
        group Id
        OG000
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Serum samples were collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
dispersion Type
Standard Deviation
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (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 500 mg dostarlimab as a 30-minute IV infusion 1 hour after belantamab mafodotin end of infusion (EOI) on day 1 of 21-day cycles (Q3W).
    id
    OG000
    title
    1.9 mg/kg Belantamab Mafodotin + 500mg Dostarlimab
param Type
MEAN
population Description
Safety Population. Only those participants with positive post-baseline antibody against belantamab mafodotin were analyzed.
reporting Status
POSTED
time Frame
Up to 153 weeks
title
DE Phase: Concentration of ADAs Against Belantamab Mafodotin
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice