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NCT04512235 · OUTCOME

Change From Baseline in N-Terminal Pro-B-type Natriuretic Peptide (NT-proBNP) in Blood Samples

A Study to Evaluate the Efficacy and Safety of CAEL-101 in Patients With Mayo Stage IIIa AL Amyloidosis (CARES) · Source last updated 2026-06-17

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 50

What was measured

For each participant, blood samples were assayed for NT-proBNP, comparing the participant's baseline value over time to assess reduced amyloidosis, as measured by a decrease in NT-proBNP. A decrease indicates cardiac enhancement. Results reported as nanograms/milliliter (ng/mL).

Analysis population: Intent-to-Treat Set: all participants who were randomized. As prespecified, data collected and reported for Intent-to-Treat Set. Here, 'Overall Number of Participants 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

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment131
Placebo + Plasma Cell Dyscrasia Treatment56

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment-957.65192.24Not reportedNot reportedNot reported
Placebo + Plasma Cell Dyscrasia Treatment-1072.33716.55Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        5192.24
        value
        -957.6
      2. group Id
        OG001
        spread
        3716.55
        value
        -1072.3
denoms
  1. counts
    1. group Id
      OG000
      value
      131
    2. group Id
      OG001
      value
      56
    units
    Participants
description
For each participant, blood samples were assayed for NT-proBNP, comparing the participant's baseline value over time to assess reduced amyloidosis, as measured by a decrease in NT-proBNP. A decrease indicates cardiac enhancement. Results reported as nanograms/milliliter (ng/mL).
dispersion Type
Standard Deviation
groups
  1. 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
  2. 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 for Intent-to-Treat Set. Here, 'Overall Number of Participants Analyzed' signifies those participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline, Week 50
title
Change From Baseline in N-Terminal Pro-B-type Natriuretic Peptide (NT-proBNP) in Blood Samples
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice