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NCT03450057 · OUTCOME

Overall Response Rate (ORR)

Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment · Source last updated 2024-03-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percent
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months)

What was measured

Overall response rate was defined as the proportion of subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response.

Groups in this outcome

Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)

Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

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

Analysis denominator · Participants

GroupSource count
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)38

Reported measurements

Source class 1
Values in Percent · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)47.4Not reported31.563.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Comment
    The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.
    non Inferiority Type
    OTHER
    other Analysis Description
    The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    The PFS function was estimated using the Kaplan-Meier product-limit method, a non-parametric statistic.
    non Inferiority Type
    OTHER
    other Analysis Description
    The PFS function was estimated using the Kaplan-Meier product-limit method. Median and two-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.5
        upper Limit
        63.2
        value
        47.4
denoms
  1. counts
    1. group Id
      OG000
      value
      38
    units
    Participants
description
Overall response rate was defined as the proportion of subjects who achieve a best response of PR or better using modified IMWG criteria as their best overall response.
dispersion Type
95% Confidence Interval
groups
  1. description
    Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients \> 75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
    id
    OG000
    title
    Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)
param Type
NUMBER
reporting Status
POSTED
time Frame
From first dose of Daratumumab until end of treatment, PD or death (approximately up to 30 months)
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percent

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

Preserved source evidence · Not medical advice