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NCT02545907 · OUTCOME

Maximum Response Determined by Paraprotein and Free Light Chain Assessment.

A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis · Source last updated 2021-04-15

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
Within 6 months

What was measured

The maximum response to therapy will be determined by assessing the best reported response for each participant. Maximum response will be determined based on free light chain and paraprotein assessments by the National Amyloidosis Centre. The data will be reported using the response rates observed (complete, very good partial, partial, no response).

Groups in this outcome

Dose Level 0- Safety Population

All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.

Dose Level 1- Safety Population

All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.

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

Analysis denominator · Participants

GroupSource count
Dose Level 0- Safety Population3
Dose Level 1- Safety Population7

Reported measurements

Source class 1

No response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0- Safety Population1Not reportedNot reportedNot reportedNot reported
Dose Level 1- Safety Population0Not reportedNot reportedNot reportedNot reported

Partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0- Safety Population0Not reportedNot reportedNot reportedNot reported
Dose Level 1- Safety Population1Not reportedNot reportedNot reportedNot reported

Very good partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0- Safety Population2Not reportedNot reportedNot reportedNot reported
Dose Level 1- Safety Population1Not reportedNot reportedNot reportedNot reported

Complete response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0- Safety Population0Not reportedNot reportedNot reportedNot reported
Dose Level 1- Safety Population3Not reportedNot reportedNot reportedNot reported

Not evaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0- Safety Population0Not reportedNot reportedNot reportedNot reported
Dose Level 1- Safety Population2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      No response
    2. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      title
      Partial response
    3. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      title
      Very good partial response
    4. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      title
      Complete response
    5. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      title
      Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    units
    Participants
description
The maximum response to therapy will be determined by assessing the best reported response for each participant. Maximum response will be determined based on free light chain and paraprotein assessments by the National Amyloidosis Centre. The data will be reported using the response rates observed (complete, very good partial, partial, no response).
groups
  1. description
    All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
    id
    OG000
    title
    Dose Level 0- Safety Population
  2. description
    All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
    id
    OG001
    title
    Dose Level 1- Safety Population
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Within 6 months
title
Maximum Response Determined by Paraprotein and Free Light Chain Assessment.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice