Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04798586 · OUTCOME

Titers of ADA

MAGNETISMM-2: Study of Elranatamab (PF-06863135) in Japanese Participants With Multiple Myeloma · Source last updated 2024-09-27

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

Measure
MEAN
Unit
Titers
Interval / dispersion
Standard Deviation
Time frame
Cycle1 Day1, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1, End of treatment (maximum of 65.1 weeks of treatment)

What was measured

Titers of ADA at specified timepoints were reported in this outcome measure.

Analysis population: Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Here, 'Number of Participants Analyzed' signifies ADA positive participants with at least one evaluable sample. 'Number Analyzed' signifies participants with non-missing ADA titers at each time point.

Groups in this outcome

Elranatamab

Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).

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

Analysis denominator · Participants

GroupSource count
Elranatamab2

Reported measurements

Cycle1 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle1 Day15

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle2 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle3 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle4 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle6 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle8 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
Cycle12 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab1
Values in Titers · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
ElranatamabNANANot reportedNot reportedData cannot be reported due to risk of re-identification of participant.
Cycle16 Day1

Analysis denominator · Participants

GroupSource count
Elranatamab0
End of treatment

Analysis denominator · Participants

GroupSource count
Elranatamab1
Values in Titers · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
ElranatamabNANANot reportedNot reportedData cannot be reported due to risk of re-identification of participant.
Complete source fields
classes
  1. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle1 Day1
  2. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle1 Day15
  3. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle2 Day1
  4. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle3 Day1
  5. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle4 Day1
  6. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle6 Day1
  7. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle8 Day1
  8. categories
    1. measurements
      1. comment
        Data cannot be reported due to risk of re-identification of participant.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    Cycle12 Day1
  9. denoms
    1. counts
      1. group Id
        OG000
        value
        0
      units
      Participants
    title
    Cycle16 Day1
  10. categories
    1. measurements
      1. comment
        Data cannot be reported due to risk of re-identification of participant.
        group Id
        OG000
        spread
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      units
      Participants
    title
    End of treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Titers of ADA at specified timepoints were reported in this outcome measure.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received an initial priming dose of 600 microgram per kilogram elranatamab subcutaneously on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1). During treatment cycle, participants were administered 1000 microgram per kilogram elranatamab weekly during each cycle (each cycle was of 3 weeks).
    id
    OG000
    title
    Elranatamab
param Type
MEAN
population Description
Immunogenicity analysis set included all enrolled participants who received at least one dose of study treatment and had at least one sample tested for ADA. Here, 'Number of Participants Analyzed' signifies ADA positive participants with at least one evaluable sample. 'Number Analyzed' signifies participants with non-missing ADA titers at each time point.
reporting Status
POSTED
time Frame
Cycle1 Day1, Cycle1 Day15, Cycle2 Day1, Cycle3 Day1, Cycle4 Day1, Cycle6 Day1, Cycle8 Day1, Cycle12 Day1, Cycle16 Day1, End of treatment (maximum of 65.1 weeks of treatment)
title
Titers of ADA
type
SECONDARY
unit Of Measure
Titers

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

Preserved source evidence · Not medical advice