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NCT04798586 · OUTCOME

Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the date of first dose up to maximum of 65.1 weeks of treatment

What was measured

'A participant was considered ADA positive if baseline titer was missing or negative and participant had \>=1 post-treatment positive titer, or positive titer at baseline and had a \>=4-fold increase in titer from baseline in \>=1 post-treatment sample.

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.

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
Elranatamab4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Elranatamab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    units
    Participants
description
'A participant was considered ADA positive if baseline titer was missing or negative and participant had \>=1 post-treatment positive titer, or positive titer at baseline and had a \>=4-fold increase in titer from baseline in \>=1 post-treatment sample.
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
COUNT_OF_PARTICIPANTS
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.
reporting Status
POSTED
time Frame
From the date of first dose up to maximum of 65.1 weeks of treatment
title
Number of Participants With Anti-drug Antibodies (ADA) of Elranatamab
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice