NCT02812706 · OUTCOME

Phase 1 and 2: CD38 Receptor Density at Baseline

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: MEAN
Unit: sMEC
Interval / dispersion: Standard Deviation
Time frame: At Baseline (Day 1)

What was measured

CD38 receptor density assessed from bone marrow aspirates for responder and non-responders' participants was reported.

Analysis population: Participants treated with Isatuximab (Phase 1 and 2) and evaluable for CD38 receptor density assessment. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

Groups in this outcome

Non-responder

Participants treated with Isatuximab, with independent adjudication committee assessment response \<PR.

Responder

Participants treated with Isatuximab, with independent adjudication committee assessment response \>=PR.

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
Non-responder	18
Responder	14

Reported measurements

Source class 1

Values in sMEC · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Non-responder	113226.2	93628.7	Not reported	Not reported	Not reported
Responder	133378.2	55518.5	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
93628.7
value
113226.2
group Id
OG001
spread
55518.5
value
133378.2

denoms

counts
group Id
OG000
value
18
group Id
OG001
value
14
units
Participants

description

CD38 receptor density assessed from bone marrow aspirates for responder and non-responders' participants was reported.

dispersion Type

Standard Deviation

groups

description
Participants treated with Isatuximab, with independent adjudication committee assessment response \<PR.
id
OG000
title
Non-responder
description
Participants treated with Isatuximab, with independent adjudication committee assessment response \>=PR.
id
OG001
title
Responder

param Type

MEAN

population Description

Participants treated with Isatuximab (Phase 1 and 2) and evaluable for CD38 receptor density assessment. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.

reporting Status

POSTED

time Frame

At Baseline (Day 1)

title

Phase 1 and 2: CD38 Receptor Density at Baseline

type

SECONDARY

unit Of Measure

sMEC

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

Preserved source evidence · Not medical advice