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NCT04304144 · OUTCOME

Number of Participants With Dose-limiting Toxicity (DLT) During the First 4 Weeks of Therapy

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

A DLT was defined as any Grade 3 or greater study intervention-related AE that was clinically significant.

Analysis population: Safety Set included all participants who were treated with at least 1 dose of CAEL-101.

Groups in this outcome

Part A: CAEL-101 500 mg/m^2 Combined With SoC CyBorD

Participants received CAEL-101 500 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.

Part A: CAEL-101 750 mg/m^2 Combined With SoC CyBorD

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.

Part A: CAEL-101 1000 mg/m^2 Combined With SoC CyBorD

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

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: CAEL-101 500 mg/m^2 Combined With SoC CyBorD4
Part A: CAEL-101 750 mg/m^2 Combined With SoC CyBorD3
Part A: CAEL-101 1000 mg/m^2 Combined With SoC CyBorD6
Part B: CAEL-101 Combined With SoC CyBorD and Daratumumab12

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: CAEL-101 500 mg/m^2 Combined With SoC CyBorD0Not reportedNot reportedNot reportedNot reported
Part A: CAEL-101 750 mg/m^2 Combined With SoC CyBorD0Not reportedNot reportedNot reportedNot reported
Part A: CAEL-101 1000 mg/m^2 Combined With SoC CyBorD0Not reportedNot reportedNot reportedNot reported
Part B: CAEL-101 Combined With SoC CyBorD and Daratumumab0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      12
    units
    Participants
description
A DLT was defined as any Grade 3 or greater study intervention-related AE that was clinically significant.
groups
  1. description
    Participants received CAEL-101 500 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.
    id
    OG000
    title
    Part A: CAEL-101 500 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
    OG001
    title
    Part A: CAEL-101 750 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, and then every other week until the end of study, in combination with the SoC CyBorD chemotherapy.
    id
    OG002
    title
    Part A: CAEL-101 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
    OG003
    title
    Part B: CAEL-101 Combined With SoC CyBorD and Daratumumab
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety Set included all participants who were treated with at least 1 dose of CAEL-101.
reporting Status
POSTED
time Frame
4 weeks
title
Number of Participants With Dose-limiting Toxicity (DLT) During the First 4 Weeks of Therapy
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice