Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02841033 · OUTCOME

Assess Organ Responses Based on Standard Criteria Included in Protocol

Daratumumab for the Treatment of Patients With AL Amyloidosis · Source last updated 2021-05-07

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
3 months

What was measured

Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (\>30% and \>300 ng/L decrease in patients with a baseline NT-proBNP \>650 ng/L; and/or NYHA class response (\> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by \> 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline

Analysis population: 19 evaluable patients with cardiac and/or renal involvement.

Groups in this outcome

Daratumumab

Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.

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

Analysis denominator · Participants

GroupSource count
Daratumumab19

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Number of patients with organ response based on standard criteria included in protocol. Cardiac response is defined as: NT-proBNP response (\>30% and \>300 ng/L decrease in patients with a baseline NT-proBNP \>650 ng/L; and/or NYHA class response (\> two-class decrease if baseline NYHA class 3 or 4) Renal response is defined as: Decrease in proteinuria by \> 30% or below 0.5 g/24 h without renal progression. Serum creatinine and creatinine clearance must not worsen by 25% over baseline
groups
  1. description
    Daratumumab, 16mg/kg body weight in 1000 mL for the first dose, followed by 500mL for subsequent doses, once weekly for two months, then every 2 weeks for four months, then once each month for up to 24 total cycles. Daratumumab: Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression, inability to tolerate, or 24 cycles completed.
    id
    OG000
    title
    Daratumumab
param Type
COUNT_OF_PARTICIPANTS
population Description
19 evaluable patients with cardiac and/or renal involvement.
reporting Status
POSTED
time Frame
3 months
title
Assess Organ Responses Based on Standard Criteria Included in Protocol
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice