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NCT02807454 · OUTCOME

Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm

A Study to Determine the Safety and Efficacy for the Combination of Durvalumab and Daratumumab in Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-21

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
From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)

What was measured

Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).

Analysis population: All enrolled participants with a partial response or better, who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms.

Groups in this outcome

Simon Stage 1: D2 Arm

Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles

Simon Stage 1: D2 + Pomalidomide + Dexamethasone

Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles

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

Analysis denominator · Participants

GroupSource count
Simon Stage 1: D2 Arm32
Simon Stage 1: D2 + Pomalidomide + Dexamethasone7

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Simon Stage 1: D2 Arm8.31Not reported3.711.1Not reported
Simon Stage 1: D2 + Pomalidomide + Dexamethasone8.41Not reported3.712.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.7
        upper Limit
        11.1
        value
        8.31
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        12.0
        value
        8.41
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    2. group Id
      OG001
      value
      7
    units
    Participants
description
Duration of response was calculated as the time from the earliest date of documented response (PR or better) to the earliest date of disease progression as determined by the investigator. For those participants where POM + DEX was added, duration of response was calculated as the time from the earliest date of documented response after POM + DEX was added (PR or better) to the earliest date of disease. Tumor response of partial response (PR) or better was assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. Partial response required ≥ 50% reduction of serum M-Protein and reduction in 24-hour urinary M protein by ≥ 90% or to \< 200 mg per 24 hours. Progressive Disease required increase of 25% from lowest response value in the serum M-component (absolute increase must be ≥ 0.5 g/dL) and/or urine M-component (absolute increase must be ≥ 200 mg/24 h).
dispersion Type
95% Confidence Interval
groups
  1. description
    Durvalumab 1500 mg + Daratumumab 16 mg/kg were administered intravenously within a 28-day cycle for a maximum of 60 cycles
    id
    OG000
    title
    Simon Stage 1: D2 Arm
  2. description
    Durvalumab 1500 mg IV + Daratumumab 16 mg/kg IV + Pomalidomide 4 mg/day Oral + Dexamethasone 40 mg Oral (20 mg for \> 75 Years Old) were administered within a 28-day cycle for a maximum of 60 cycles
    id
    OG001
    title
    Simon Stage 1: D2 + Pomalidomide + Dexamethasone
param Type
MEDIAN
population Description
All enrolled participants with a partial response or better, who received at least 1 dose of the study medication, and who have measurable disease at baseline and at least 1 postbaseline efficacy assessment. Pre-specified for data to be collected only in D2 and D2 + Pomalidomide + Dexamethasone arms.
reporting Status
POSTED
time Frame
From the earliest date of documented response (PR or better) to earliest date of progressive disease (up to approximately 66 months)
title
Kaplan-Meier Estimate of Duration of Response (DOR) - Simon Stage 1: D2 Arm
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice