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NCT04177823 · OUTCOME

Number of Participants With Dose Limited Toxicities (DLTs)

A Study of Belantamab Mafodotin to Investigate Safety, Tolerability, Pharmacokinetics, Immunogenicity and Clinical Activity in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2025-03-20

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
Day 1 to day 21 of cycle 1

What was measured

An event was considered DLT if it occurred within 21 days of treatment and met any of the following criteria within same period: * Any Grade (Gr.) 3 or greater non-hematologic toxicity as described in NCI-CTCAE Version 5.0, other than corneal events that persists for \>48 hours despite supportive treatment or leads to hospitalization. * Hematologic toxicity such as Gr. 3 or greater febrile neutropenia lasting \>48 hours despite adequate treatment (Gr. 3 defined as absolute neutrophil count (ANC) \<1000/millimeter cube (mm\^3) at a single temperature \>38.3 degree celsius or a sustained temperature \>=38 degree celsius for more than 1 hour) and, Gr. 4 thrombocytopenia defined as platelet count \<25000/mm\^3 with clinically significant bleeding, or if platelet transfusion is required. * Gr. 4 per the corneal grading scale. * Liver toxicity meeting pre-specified by GSK liver stopping criteria.

Analysis population: DLT evaluable population included all the eligible participants who have received the 1st dose as planned and experienced a DLT during the cycle 1 or completed the cycle 1.

Groups in this outcome

Belantamab Mafodotin

Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.

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

Analysis denominator · Participants

GroupSource count
Belantamab Mafodotin6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Belantamab Mafodotin1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
An event was considered DLT if it occurred within 21 days of treatment and met any of the following criteria within same period: * Any Grade (Gr.) 3 or greater non-hematologic toxicity as described in NCI-CTCAE Version 5.0, other than corneal events that persists for \>48 hours despite supportive treatment or leads to hospitalization. * Hematologic toxicity such as Gr. 3 or greater febrile neutropenia lasting \>48 hours despite adequate treatment (Gr. 3 defined as absolute neutrophil count (ANC) \<1000/millimeter cube (mm\^3) at a single temperature \>38.3 degree celsius or a sustained temperature \>=38 degree celsius for more than 1 hour) and, Gr. 4 thrombocytopenia defined as platelet count \<25000/mm\^3 with clinically significant bleeding, or if platelet transfusion is required. * Gr. 4 per the corneal grading scale. * Liver toxicity meeting pre-specified by GSK liver stopping criteria.
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
    id
    OG000
    title
    Belantamab Mafodotin
param Type
COUNT_OF_PARTICIPANTS
population Description
DLT evaluable population included all the eligible participants who have received the 1st dose as planned and experienced a DLT during the cycle 1 or completed the cycle 1.
reporting Status
POSTED
time Frame
Day 1 to day 21 of cycle 1
title
Number of Participants With Dose Limited Toxicities (DLTs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice