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NCT03544281 · OUTCOME

AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A

To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-18

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

Measure
GEOMETRIC_MEAN
Unit
h*ug/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7

What was measured

Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.

Analysis population: Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.

Groups in this outcome

Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex

Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.

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 Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex5

Reported measurements

Source class 1
Values in h*ug/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex8143.8530.12Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.12
        value
        8143.85
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Blood samples were collected at indicated timepoints for PK analysis. PK parameter was determined using standard non-compartmental methods. AUC(0-1008) was derived only for Belantamab mafodotin 1.9mg/kg + Len/Dex STRETCH cohort.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 1.9 milligram (mg)/kilogram (kg) dose on Day 1 of every alternate 28-day cycles (C1, C3, C5, C7 and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide (Len) was administered as 25 mg or 10 mg per oral (PO) on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone (Dex) weekly PO/ intravenously (IV) on Days 1, 8, 15 and 22 of each cycle.
    id
    OG000
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex
param Type
GEOMETRIC_MEAN
population Description
Pharmacokinetic (PK) population. Only those participants with data available at specified time points have been analyzed.
reporting Status
POSTED
time Frame
Pre-Dose, 0, 2 and 24 Hours Post-Dose on Cycle 1 Day 1; Cycle 1 Day 4; Cycle 1 Day 8; Cycle 1 Day 29; Pre-Dose and Post-Dose on Week 5 Day 7
title
AUC (0-1008h) for Belantamab Mafodotin (Total Antibody), Treatment A
type
SECONDARY
unit Of Measure
h*ug/mL

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

Preserved source evidence · Not medical advice