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NCT02841033 · OUTCOME

Assess Hematologic Response Based on Blood and Urine Testing Using Standard Criteria

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 hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic 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; and a PR is dFLC reduction by \>50%. \* "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, Very Good Partial Response, or Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab20Not reportedNot reportedNot reportedNot reported

Stable Disease or Progressive Disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Daratumumab2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20
      title
      Complete Response, Very Good Partial Response, or Partial Response
    2. measurements
      1. group Id
        OG000
        value
        2
      title
      Stable Disease or Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Number of patients with hematologic complete response (CR), very good partial response (VGPR), or partial response (PR). Per protocol, a hematologic 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; and a PR is dFLC reduction by \>50%. \* "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 Hematologic Response Based on Blood and Urine Testing Using Standard Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice