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NCT05986682 · OUTCOME

Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]

Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2025-02-03

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

Measure
COUNT_OF_UNITS
Unit
BVCA Changes
Interval / dispersion
Not reported
Time frame
Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.

What was measured

Ocular toxicity as measured by changes to BVCA as measured per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS \[Risk Evaluation and Mitigation Strategies\] guidelines. BVCA changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: No decline from baseline on Snellen Visual Acuity. Grade 1: Decline from baseline of 1 line on Snellen Visual Acuity. Grade 2: Decline from baseline of 2 or 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 3: Decline from baseline of more than 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 4: Snellen Visual Acuity worse than 20/200. The Data table reports the total number of BVCA changes experienced, along with counts and percentage by grade of change.

Analysis population: The 30 patients in the study experienced ocular toxicity (changes to BVCA) a total of 244 times as reported during clinic visits. The analysis population is the 244 BVCA changes reported.

Groups in this outcome

Multiple Myeloma/Blenrep Participants

Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023

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

Analysis denominator · Participants

GroupSource count
Multiple Myeloma/Blenrep Participants30

Analysis denominator · BVCA Changes

GroupSource count
Multiple Myeloma/Blenrep Participants244

Reported measurements

Total Number of Changes to BVCA
Values in BVCA Changes · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants244Not reportedNot reportedNot reportedNot reported
Grade 1
Values in BVCA Changes · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants125Not reportedNot reportedNot reportedNot reported
Grade 2
Values in BVCA Changes · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants111Not reportedNot reportedNot reportedNot reported
Grade 3
Values in BVCA Changes · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants8Not reportedNot reportedNot reportedNot reported
Grade 4
Values in BVCA Changes · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        244
    title
    Total Number of Changes to BVCA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        125
    title
    Grade 1
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        111
    title
    Grade 2
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 3
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 4
denom Units Selected
BVCA Changes
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      244
    units
    BVCA Changes
description
Ocular toxicity as measured by changes to BVCA as measured per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS \[Risk Evaluation and Mitigation Strategies\] guidelines. BVCA changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: No decline from baseline on Snellen Visual Acuity. Grade 1: Decline from baseline of 1 line on Snellen Visual Acuity. Grade 2: Decline from baseline of 2 or 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 3: Decline from baseline of more than 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 4: Snellen Visual Acuity worse than 20/200. The Data table reports the total number of BVCA changes experienced, along with counts and percentage by grade of change.
groups
  1. description
    Participants with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023
    id
    OG000
    title
    Multiple Myeloma/Blenrep Participants
param Type
COUNT_OF_UNITS
population Description
The 30 patients in the study experienced ocular toxicity (changes to BVCA) a total of 244 times as reported during clinic visits. The analysis population is the 244 BVCA changes reported.
reporting Status
POSTED
time Frame
Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
title
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
type
POST_HOC
type Units Analyzed
BVCA Changes
unit Of Measure
BVCA Changes

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

Preserved source evidence · Not medical advice