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NCT01794520 · OUTCOME

Phase 2: Progression-Free Survival (PFS)

Study Evaluating ABT-199 in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-04-10

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
Estimated median duration of follow-up was 31.7 months

What was measured

PFS is defined as the number of days from the date of the first dose of study treatment to the date of first documented disease progression or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.

Analysis population: All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; this endpoint was pre-specified for Phase 2 only, data are reported for all participants with available data

Groups in this outcome

Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).

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

Analysis denominator · Participants

GroupSource count
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg31

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg11.2Not reported5.218.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.2
        upper Limit
        18.4
        value
        11.2
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
PFS is defined as the number of days from the date of the first dose of study treatment to the date of first documented disease progression or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.
dispersion Type
95% Confidence Interval
groups
  1. description
    The Phase 2 cohort further explored the efficacy of venetoclax in combination with dexamethasone in relapsed or refractory participants with t(11;14) translocation multiple myeloma. Participants received daily venetoclax at a dose of 800 mg (no lead-in period) on Days 1- 21 of each cycle concomitant with weekly dexamethasone at a dose of 40 mg (20 mg for those aged ≥ 75 years).
    id
    OG000
    title
    Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
param Type
MEDIAN
population Description
All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; this endpoint was pre-specified for Phase 2 only, data are reported for all participants with available data
reporting Status
POSTED
time Frame
Estimated median duration of follow-up was 31.7 months
title
Phase 2: Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice