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NCT05986682 · OUTCOME

Clinical Outcomes: Best Overall Response

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_PARTICIPANTS
Unit
Participants
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

Response categorized using modified IMWG 2016 criteria. Urine testing was not routinely done; only serum M-protein levels were used when determining response. Complete Response(CR)= negative immunofixation on the serum + absence of any soft tissue plasmacytomas + \<5% plasma cells in bone marrow aspirates. Very Good Partial Response(VGPR) = serum detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein. Partial Response(PR) = ≥50% reduction of serum M-protein. If the serum is unmeasurable, a \> 50% decrease in the difference between involved and uninvolved FLC levels is required. Stable Disease (SD) = not meeting criteria for CR, VGPR, PR, or progressive disease. Progressive Disease (PD) = \>25% increase from lowest response value in serum M-protein (the absolute increase must be \>0.5 g/dL), or definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.

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

Reported measurements

CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants0Not reportedNot reportedNot reportedNot reported
VGPR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants11Not reportedNot reportedNot reportedNot reported
PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants9Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants9Not reportedNot reportedNot reportedNot reported
PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Multiple Myeloma/Blenrep Participants1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    PR
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    SD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    PD
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    units
    Participants
description
Response categorized using modified IMWG 2016 criteria. Urine testing was not routinely done; only serum M-protein levels were used when determining response. Complete Response(CR)= negative immunofixation on the serum + absence of any soft tissue plasmacytomas + \<5% plasma cells in bone marrow aspirates. Very Good Partial Response(VGPR) = serum detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein. Partial Response(PR) = ≥50% reduction of serum M-protein. If the serum is unmeasurable, a \> 50% decrease in the difference between involved and uninvolved FLC levels is required. Stable Disease (SD) = not meeting criteria for CR, VGPR, PR, or progressive disease. Progressive Disease (PD) = \>25% increase from lowest response value in serum M-protein (the absolute increase must be \>0.5 g/dL), or definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
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_PARTICIPANTS
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
Clinical Outcomes: Best Overall Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice