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NCT04504825 · OUTCOME

Frequency of CVHs

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
NUMBER
Unit
CV-related hospitalizations/year
Interval / dispersion
95% Confidence Interval
Time frame
Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, analysis for the study was conducted 18-47 months after the study randomization.)

What was measured

CVHs were those events that were adjudicated and confirmed as such by the CEAC. Frequency of CEAC-adjudicated CVH was calculated using negative binomial regression analysis with study intervention, study, geographic region, daratumumab usage at Baseline, and offset term equal to log of each participant's follow-up time for cardiovascular hospitalization included in the model.

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'.

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 Treatment84
Placebo + Plasma Cell Dyscrasia Treatment41

Reported measurements

Overall (All Randomized Participants)

Analysis denominator · Participants

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment84
Placebo + Plasma Cell Dyscrasia Treatment41
Values in CV-related hospitalizations/year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment0.93Not reported0.541.60Not reported
Placebo + Plasma Cell Dyscrasia Treatment1.73Not reported0.823.68Not reported
FLC Subtype Kappa

Analysis denominator · Participants

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment25
Placebo + Plasma Cell Dyscrasia Treatment6
Values in CV-related hospitalizations/year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment0.34Not reported0.160.73Not reported
Placebo + Plasma Cell Dyscrasia Treatment2.50Not reported0.748.49Not reported
FLC Subtype Lambda

Analysis denominator · Participants

GroupSource count
CAEL-101 + Plasma Cell Dyscrasia Treatment57
Placebo + Plasma Cell Dyscrasia Treatment34
Values in CV-related hospitalizations/year · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CAEL-101 + Plasma Cell Dyscrasia Treatment1.00Not reported0.482.07Not reported
Placebo + Plasma Cell Dyscrasia Treatment1.22Not reported0.503.01Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.54
        upper Limit
        1.60
        value
        0.93
      2. group Id
        OG001
        lower Limit
        0.82
        upper Limit
        3.68
        value
        1.73
    denoms
    1. counts
      1. group Id
        OG000
        value
        84
      2. group Id
        OG001
        value
        41
      units
      Participants
    title
    Overall (All Randomized Participants)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.16
        upper Limit
        0.73
        value
        0.34
      2. group Id
        OG001
        lower Limit
        0.74
        upper Limit
        8.49
        value
        2.50
    denoms
    1. counts
      1. group Id
        OG000
        value
        25
      2. group Id
        OG001
        value
        6
      units
      Participants
    title
    FLC Subtype Kappa
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.48
        upper Limit
        2.07
        value
        1.00
      2. group Id
        OG001
        lower Limit
        0.50
        upper Limit
        3.01
        value
        1.22
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      2. group Id
        OG001
        value
        34
      units
      Participants
    title
    FLC Subtype Lambda
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    2. group Id
      OG001
      value
      41
    units
    Participants
description
CVHs were those events that were adjudicated and confirmed as such by the CEAC. Frequency of CEAC-adjudicated CVH was calculated using negative binomial regression analysis with study intervention, study, geographic region, daratumumab usage at Baseline, and offset term equal to log of each participant's follow-up time for cardiovascular hospitalization included in the model.
dispersion Type
95% Confidence Interval
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
NUMBER
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'.
reporting Status
POSTED
time Frame
Day 1 through end of the participant's PETP (Participants were enrolled on a rolling basis. Therefore, analysis for the study was conducted 18-47 months after the study randomization.)
title
Frequency of CVHs
type
SECONDARY
unit Of Measure
CV-related hospitalizations/year

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

Preserved source evidence · Not medical advice