NCT02812706 · OUTCOME

Phase 2: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab

Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients · Source last updated 2024-04-01

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 first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 248 weeks)

What was measured

ADA were categorized as: treatment induced, and treatment boosted response. Treatment-induced ADA: ADA that developed at any time during the ADA on-study observation period in participants without preexisting ADA (ADA that was present in samples drawn during the ADA pretreatment period). Treatment boosted ADA: Preexisting ADA with an increase in titer value between pretreatment \& posttreatment samples of at least two titer steps, during the ADA on-study observation period.

Analysis population: Analysis was performed on ADA population which included all participants that received isatuximab in Phase 2 part of the study, with at least one ADA assessment reportable during the ADA on-study observation periods.

Groups in this outcome

Phase 2: Isatuximab 20 mg/kg

Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).

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

Analysis denominator · Participants

Group	Source count
Phase 2: Isatuximab 20 mg/kg	28

Reported measurements

Treatment-induced ADA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Isatuximab 20 mg/kg	6	Not reported	Not reported	Not reported	Not reported

Treatment boosted ADA

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase 2: Isatuximab 20 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
6
title
Treatment-induced ADA
categories
measurements
group Id
OG000
value
0
title
Treatment boosted ADA

denoms

counts
group Id
OG000
value
28
units
Participants

description

groups

description
Participants received Isatuximab 20 mg/kg IV infusion, QW for 4 weeks (i.e., on Day 1, Day 8, Day 15 and Day 22 of Cycle 1), and then Q2W (i.e., on Day 1 and 15) for subsequent treatment cycles (each cycle of 28 days) until unacceptable AEs, disease progression, or any other reason for discontinuation whichever occurs first (maximum duration of exposure: 248 weeks).
id
OG000
title
Phase 2: Isatuximab 20 mg/kg

param Type

COUNT_OF_PARTICIPANTS

population Description

Analysis was performed on ADA population which included all participants that received isatuximab in Phase 2 part of the study, with at least one ADA assessment reportable during the ADA on-study observation periods.

reporting Status

POSTED

time Frame

From first dose of study drug up to 30 days after last study drug administration (maximum duration of exposure: up to 248 weeks)

title

Phase 2: Number of Participants With Anti-drug Antibodies (ADA) Response Against Isatuximab

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice