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NCT03567616 · OUTCOME

Duration of Response (DOR)

A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2021-06-30

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

Measure
MEDIAN
Unit
days
Interval / dispersion
95% Confidence Interval
Time frame
Approximately 15 months

What was measured

DOR for a given participant is defined as the number of days from the date of that participant's first documented response (Partial Response \[PR\] or better) to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant with a documented response did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored.

Analysis population: Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) and had disease progression or death due to multiple myeloma

Groups in this outcome

Participants Positive for t(11;14) Translocation

Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

Participants Negative for t(11;14) Translocation

Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

All Participants

Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

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

Analysis denominator · Participants

GroupSource count
Participants Positive for t(11;14) Translocation2
Participants Negative for t(11;14) Translocation3
All Participants5

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Participants Positive for t(11;14) Translocation393.0Not reportedNANANot calculable/estimable due to low number of participants with events
Participants Negative for t(11;14) TranslocationNANot reportedNANANot calculable/estimable due to low number of participants with events
All Participants393.0Not reportedNANANot calculable/estimable due to low number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not calculable/estimable due to low number of participants with events
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        393.0
      2. comment
        Not calculable/estimable due to low number of participants with events
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Not calculable/estimable due to low number of participants with events
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        393.0
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      5
    units
    Participants
description
DOR for a given participant is defined as the number of days from the date of that participant's first documented response (Partial Response \[PR\] or better) to the date of first documented disease progression (PD) or death due to multiple myeloma (MM), whichever occurs first. If the participant with a documented response did not have an event of PD and the participant had not died due to MM, the participant's data was to be censored.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    id
    OG000
    title
    Participants Positive for t(11;14) Translocation
  2. description
    Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    id
    OG001
    title
    Participants Negative for t(11;14) Translocation
  3. description
    Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    id
    OG002
    title
    All Participants
param Type
MEDIAN
population Description
Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg) and had disease progression or death due to multiple myeloma
reporting Status
POSTED
time Frame
Approximately 15 months
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice