Participant flow

A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis · Source last updated 2025-03-05

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

groups

1. description

   Participants received CAEL-101 500 milligrams (mg)/square meter (m\^2) administered weekly as an intravenous (IV) infusion the first 4 weeks (dose limiting toxicity \[DLT\] observation period), and thereafter received CAEL-101 at the recommended phase 3 dose (RP3D) (1000 mg/m\^2) every other week until the end of study, in combination with the standard of care (SoC) CyBorD (cyclophosphamide, bortezomib, dexamethasone) chemotherapy.

   id

   FG000

   title

   Part A: CAEL101 500 mg/m^2 Combined With SoC CyBorD

2. description

   Participants received CAEL-101 750 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period), and thereafter received CAEL-101 at the RP3D (1000 mg/m\^2) every other week until the end of study, in combination with the SoC CyBorD chemotherapy.

   id

   FG001

   title

   Part A: CAEL101 750 mg/m^2 Combined With SoC CyBorD

3. description

   Participants received CAEL-101 1000 mg/m\^2 administered weekly as an IV infusion the first 4 weeks (DLT observation period), and then every other week until the end of study, in combination with the SoC CyBorD chemotherapy.

   id

   FG002

   title

   Part A: CAEL101 1000 mg/m^2 Combined With SoC CyBorD

4. description

   Participants received CAEL-101 at the RP3D (1000 mg/m\^2) administered weekly as an IV infusion for the first 4 weeks, and then every other week until end of study, in combination with the SoC CyBorD chemotherapy and daratumumab.

   id

   FG003

   title

   Part B: CAEL-101 Combined With SoC CyBorD and Daratumumab

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Physician Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         0

      type

      Received At Least 1 Dose of Study Drug

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         0

      comment

      Study Completion

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      NOT COMPLETED

   title

   DLT Observation Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         3

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      type

      Other than specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         12

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         6

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Continued Treatment Period

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Preserved source evidence · Not medical advice