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NCT03029234 · OUTCOME

Duration of Clinical Benefit (DCB)

Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Patients With Relapsed & Refractory Multiple Myeloma · Source last updated 2022-05-25

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
Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.

What was measured

Duration of clinical benefit (DCB) is defined as the time from first evidence of MR or better to disease progression or death due to any cause based on the (IMWG-URC criteria. DCB was estimated using the Kaplan-Meier method; participants with no disease progression or death at the analysis cut-off date were censored at their last disease assessment date. Duration of clinical benefit was determined based on both investigator and independent review committee response assessments.

Analysis population: Safety population participants who achieved a best overall response of minimal response or better.

Groups in this outcome

Carfilzomib With Dexamethasone

Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone59

Reported measurements

Independent Review Committee Assessment

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone59
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone8.3Not reported7.315.1Not reported
Investigator Assessment

Analysis denominator · Participants

GroupSource count
Carfilzomib With Dexamethasone57
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib With Dexamethasone8.6Not reported7.415.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.3
        upper Limit
        15.1
        value
        8.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Independent Review Committee Assessment
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.4
        upper Limit
        15.1
        value
        8.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        57
      units
      Participants
    title
    Investigator Assessment
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
description
Duration of clinical benefit (DCB) is defined as the time from first evidence of MR or better to disease progression or death due to any cause based on the (IMWG-URC criteria. DCB was estimated using the Kaplan-Meier method; participants with no disease progression or death at the analysis cut-off date were censored at their last disease assessment date. Duration of clinical benefit was determined based on both investigator and independent review committee response assessments.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
    id
    OG000
    title
    Carfilzomib With Dexamethasone
param Type
MEDIAN
population Description
Safety population participants who achieved a best overall response of minimal response or better.
reporting Status
POSTED
time Frame
Response was assessed every 28 days until disease progression; the data cut-off date was 15 March 2019; median follow-up time for progression assessed by independent review committee and by investigators were 12.8 months and 13.1 months, respectively.
title
Duration of Clinical Benefit (DCB)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice