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NCT03450057 · OUTCOME

Duration of Response in Patients With RI

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Assessed monthly from first dose of Daratumumab until PD or death from any cause (approximately up to 30 months)

What was measured

Duration of response was restricted to the subjects that achieve a best objective response of PR or better. It was measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).

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)18

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)28.4Not reported15.1NAThe upper limit was not reached (NR).

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 one-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 one-sided confidence intervals (CIs) for PFS were computed and Kaplan-Meier plots of PFS were developed.
classes
  1. categories
    1. measurements
      1. comment
        The upper limit was not reached (NR).
        group Id
        OG000
        lower Limit
        15.1
        upper Limit
        NA
        value
        28.4
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Duration of response was restricted to the subjects that achieve a best objective response of PR or better. It was measured from the time, in months, that the criteria for objective response are first met until the date of a progression event (according to the primary definition of PFS).
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
MEDIAN
reporting Status
POSTED
time Frame
Assessed monthly from first dose of Daratumumab until PD or death from any cause (approximately up to 30 months)
title
Duration of Response in Patients With RI
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice