NCT04504825 · OUTCOME

Change From Baseline in Global Longitudinal Strain (GLS%)

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIb AL Amyloidosis (CARES) · Source last updated 2026-07-02

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

Measure: MEAN
Unit: percentage of myocardial shortening
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 50

What was measured

Change in heart function was measured by GLS%, a noninvasive imaging technique that uses echocardiography to assess heart. GLS% expresses longitudinal shortening as a percentage (change in length as a proportion to baseline length) and is reported as a negative value. A more negative value is usually associated with cardiac enhancement.

Analysis population: Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.

Groups in this outcome

CAEL-101 + Plasma Cell Dyscrasia Treatment

During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.

Placebo + Plasma Cell Dyscrasia Treatment

During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.

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
CAEL-101 + Plasma Cell Dyscrasia Treatment	33
Placebo + Plasma Cell Dyscrasia Treatment	15

Reported measurements

Overall (All Randomized Participants)

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	33
Placebo + Plasma Cell Dyscrasia Treatment	15

Values in percentage of myocardial shortening · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
CAEL-101 + Plasma Cell Dyscrasia Treatment	0.21	4.147	Not reported	Not reported	Not reported
Placebo + Plasma Cell Dyscrasia Treatment	1.77	3.711	Not reported	Not reported	Not reported

FLC Subtype Kappa

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	13
Placebo + Plasma Cell Dyscrasia Treatment	0

Values in percentage of myocardial shortening · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
CAEL-101 + Plasma Cell Dyscrasia Treatment	-1.38	3.246	Not reported	Not reported	Not reported

FLC Subtype Lambda

Analysis denominator · Participants

Group	Source count
CAEL-101 + Plasma Cell Dyscrasia Treatment	19
Placebo + Plasma Cell Dyscrasia Treatment	15

Values in percentage of myocardial shortening · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
CAEL-101 + Plasma Cell Dyscrasia Treatment	0.69	3.744	Not reported	Not reported	Not reported
Placebo + Plasma Cell Dyscrasia Treatment	1.77	3.711	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
4.147
value
0.21
group Id
OG001
spread
3.711
value
1.77
denoms
counts
group Id
OG000
value
33
group Id
OG001
value
15
units
Participants
title
Overall (All Randomized Participants)
categories
measurements
group Id
OG000
spread
3.246
value
-1.38
denoms
counts
group Id
OG000
value
13
group Id
OG001
value
0
units
Participants
title
FLC Subtype Kappa
categories
measurements
group Id
OG000
spread
3.744
value
0.69
group Id
OG001
spread
3.711
value
1.77
denoms
counts
group Id
OG000
value
19
group Id
OG001
value
15
units
Participants
title
FLC Subtype Lambda

denoms

counts
group Id
OG000
value
33
group Id
OG001
value
15
units
Participants

description

dispersion Type

Standard Deviation

groups

description
During the PETP, participants were administered CAEL-101 as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
id
OG000
title
CAEL-101 + Plasma Cell Dyscrasia Treatment
description
During the PETP, participants were administered placebo as an IV infusion over approximately 2 hours, in addition to SoC plasma cell dyscrasia treatment. All participants continued their double-blind treatment until LPI+18 months. All participants had the option to enter into the OLEP, where they continued to receive CAEL-101 in addition to any SoC prescribed by a physician.
id
OG001
title
Placebo + Plasma Cell Dyscrasia Treatment

param Type

MEAN

population Description

Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported as 'Overall (All Randomized Participants)' and per subgroups 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. Here, 'Overall Number of Participants Analyzed' and 'Number Analyzed' signifies those participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Baseline, Week 50

title

Change From Baseline in Global Longitudinal Strain (GLS%)

type

SECONDARY

unit Of Measure

percentage of myocardial shortening

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

Preserved source evidence · Not medical advice