Participant flow

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.

groups

1. description

   During the PETP, participants were administered CAEL-101 as an intravenous (IV) infusion over approximately 2 hours, in addition to standard-of-care (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

   FG000

   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

   FG001

   title

   Placebo + Plasma Cell Dyscrasia Treatment

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         22

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Participant received heart transplant or left ventricular assist device

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         84

      2. group Id

         FG001

         num Subjects

         41

      comment

      Intent-to-treat Set: all participants who were randomized

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         84

      2. group Id

         FG001

         num Subjects

         40

      comment

      Safety Set: all randomized participants who received at least 1 dose of the study intervention.

      type

      Received at Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         25

      2. group Id

         FG001

         num Subjects

         6

      comment

      Participants with the Kappa FLC subtype who were randomized and received at least 1 dose of study drug in this subgroup.

      type

      Kappa FLC Subtype

   4. achievements

      1. group Id

         FG000

         num Subjects

         57

      2. group Id

         FG001

         num Subjects

         34

      comment

      Participants with the Lambda FLC subtype who were randomized and received at least 1 dose of study drug in this subgroup.

      type

      Lambda FLC Subtype

   5. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         14

      comment

      Based upon Safety Set: all randomized participants who received at least 1 dose of the study intervention.

      type

      Entered OLEP

   6. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         4

      comment

      Based upon Safety Set: all randomized participants who received at least 1 dose of the study intervention.

      type

      Did Not Enter OLEP

   7. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         18

      comment

      Only deaths indicated as leading to study discontinuation are reported in the Participant Flow section. All deaths regardless of causality or whether they were reported as a reason for study discontinuation are reported in the All-Cause Mortality section.

      type

      COMPLETED

   8. achievements

      1. group Id

         FG000

         num Subjects

         53

      2. group Id

         FG001

         num Subjects

         23

      type

      NOT COMPLETED

   title

   PETP

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         14

      type

      Study ongoing

   milestones

   1. achievements

      1. comment

         Not every participant that completed the PETP entered the OLEP

         group Id

         FG000

         num Subjects

         21

      2. comment

         Not every participant that completed the PETP entered the OLEP

         group Id

         FG001

         num Subjects

         14

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         14

      type

      NOT COMPLETED

   title

   OLEP

pre Assignment Details

Subgroup analyses reported for 2 free light chain (FLC) isotypes (Kappa, Lambda) as following subgroups, 'Kappa FLC Subtype' and 'Lambda FLC Subtype'. The sum of the participants for the "CAEL-101 + Plasma Cell Dyscrasia Treatment" Arm/Group in the "Kappa FLC Subtype" and "Lambda FLC Subtype" Rows (25+57=82) appears inconsistent with the number of participants specified in the "Received at Least 1 Dose of Study Drug" Row (84) due to 2 participants were not classified as either kappa or lambda

recruitment Details

This study consisted of 2 periods: the Primary Evaluation Treatment Period (PETP) and the Open-label Extension Period (OLEP). Primary analysis data reported based only on data collected through the end of the participant's PETP (last participant in \[LPI\] plus 18 months). Final data will be reported after study completion.

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Preserved source evidence · Not medical advice