Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02841033 · OUTCOME

Assess the Number of Patients Who Respond to Treatment

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 participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L, a PR is dFLC reduction by \>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \>100 mg/L. \* "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.

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
Daratumumab22

Reported measurements

Source class 1

Complete Response (CR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab5Not reportedNot reportedNot reportedNot reported

Very Good Partial Response (VGPR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab13Not reportedNot reportedNot reportedNot reported

Partial Response (PR)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab2Not reportedNot reportedNot reportedNot reported

Stable Disease (SD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab1Not reportedNot reportedNot reportedNot reported

Progressive Disease (PD)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      Complete Response (CR)
    2. measurements
      1. group Id
        OG000
        value
        13
      title
      Very Good Partial Response (VGPR)
    3. measurements
      1. group Id
        OG000
        value
        2
      title
      Partial Response (PR)
    4. measurements
      1. group Id
        OG000
        value
        1
      title
      Stable Disease (SD)
    5. measurements
      1. group Id
        OG000
        value
        1
      title
      Progressive Disease (PD)
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Number of participants with response and ability to tolerate study treatment in each of these categories: Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD). All participants were able to tolerate study treatment. Per protocol, overall response designations are a combination of hematologic response. A CR is defined as negative serum and urine immunofixation electrophoresis with normal serum free light chain ratio; a VGPR is reduction in the dFLC\* to \<40 mg/L, a PR is dFLC reduction by \>50%; SD is not meeting criteria for CR, VGPR, PR, or PD; and PD is an increase in FLC of 50% to \>100 mg/L. \* "dFLC" is difference in involved and uninvolved serum Free Light-Chain levels.
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
reporting Status
POSTED
time Frame
3 months
title
Assess the Number of Patients Who Respond to Treatment
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice