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NCT03544281 · OUTCOME

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 4.5 years

What was measured

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).

Analysis population: All treated population included all participants who received at least one dose of study treatment.

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.

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

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.

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

Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex

Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex

Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.

Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex

Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 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
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex12
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex16
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex13
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16

Reported measurements

Any AE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex12Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex4Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex13Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex16Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex12Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex12Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex12Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex12Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex13Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex18Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex12Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex16Not reportedNot reportedNot reportedNot reported
Any SAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Main Study Phase: Belantamab Mafodotin 1.9mg/kg STRETCH + Len/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex2Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex10Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex8Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex8Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex7Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex13Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex6Not reportedNot reportedNot reportedNot reported
Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        13
      4. group Id
        OG003
        value
        16
      5. group Id
        OG004
        value
        12
      6. group Id
        OG005
        value
        12
      7. group Id
        OG006
        value
        12
      8. group Id
        OG007
        value
        12
      9. group Id
        OG008
        value
        13
      10. group Id
        OG009
        value
        18
      11. group Id
        OG010
        value
        12
      12. group Id
        OG011
        value
        16
    title
    Any AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        8
      6. group Id
        OG005
        value
        8
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        6
      9. group Id
        OG008
        value
        7
      10. group Id
        OG009
        value
        13
      11. group Id
        OG010
        value
        6
      12. group Id
        OG011
        value
        9
    title
    Any SAE
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      13
    4. group Id
      OG003
      value
      16
    5. group Id
      OG004
      value
      12
    6. group Id
      OG005
      value
      12
    7. group Id
      OG006
      value
      12
    8. group Id
      OG007
      value
      12
    9. group Id
      OG008
      value
      13
    10. group Id
      OG009
      value
      18
    11. group Id
      OG010
      value
      12
    12. group Id
      OG011
      value
      16
    units
    Participants
description
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent disability/incapacity or Is a congenital anomaly/birth defect, Other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. A summary of number of participants with any AEs and SAEs are presented. AEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
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
  2. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG001
    title
    Main Study Phase: Belantamab Mafodotin 1.9mg/kg SINGLE + Len/Dex
  3. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg dose on Day 1 and a 1.25 mg/kg dose on Day 8 of each 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG002
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SPLIT + Len/Dex
  4. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 28-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Lenalidomide was administered as 25 mg or 10 mg PO on Days 1-21 of each 28-day cycle with 40 mg Dexamethasone weekly PO/ IV on Days 1, 8, 15 and 22 of each cycle.
    id
    OG003
    title
    Main Study Phase: Belantamab Mafodotin 2.5mg/kg SINGLE + Len/Dex
  5. description
    Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of every alternate 21-day cycle (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib (Bor) was administered as 1.3 milligrams per square meters (mg/m\^2) subcutaneously (SC) /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone (Dex) PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG004
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg STRETCH + Bor/Dex
  6. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 1.9 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG005
    title
    Main Study Phase: Belantamab Mafodotin 1.9 mg/kg SINGLE + Bor/Dex
  7. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on cycle 1 day 1 (C1D1) followed by 1.9 mg/kg step-down dose on Day 1 of every alternate 21-day cycles C3 onwards (C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG006
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg Step-Down STRETCH+ Bor/Dex
  8. description
    Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every alternate 21-day cycles (C1, C3, C5, C7, and so on) as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG007
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg STRETCH + Bor/Dex
  9. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 2.5mg/kg dose as a 1.25 mg/kg on Day 1 and 1.25 mg/kg dose on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG008
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SPLIT + Bor/Dex
  10. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 2.5 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG009
    title
    Main Study Phase: Belantamab Mafodotin 2.5 mg/kg SINGLE + Bor/Dex
  11. description
    Participants with RRMM received belantamab mafodotin as two equal divided doses of a total 3.4 mg/kg dose as a 1.7 mg/kg dose on Day 1 and 1.7 mg/kg on Day 8 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG010
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SPLIT + Bor/Dex
  12. description
    Participants with RRMM received belantamab mafodotin as SINGLE full dose of 3.4 mg/kg on Day 1 of every 21-day cycle as a 30-60 minute infusion. Along with belantamab mafodotin, Bortezomib was administered as 1.3 mg/m\^2 SC /IV on Days 1, 4, 8, and 11 with 20 mg Dexamethasone PO/IV on Days 1, 2, 4, 5, 8, 9, 11, and 12 of every 21-day cycle up to 8 cycles.
    id
    OG011
    title
    Main Study Phase: Belantamab Mafodotin 3.4 mg/kg SINGLE + Bor/Dex
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated population included all participants who received at least one dose of study treatment.
reporting Status
POSTED
time Frame
Up to approximately 4.5 years
title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice