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NCT01794520 · OUTCOME

Phase 2: Overall Response Rate

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months

What was measured

Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2016 standard International Myeloma Working Group (IMWG) criteria.

Analysis population: All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; primary efficacy endpoints were pre-specified for Phase 2 only, and 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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2 Expansion: Venetoclax 800 mg/Dexamethasone 20 or 40 mg48.4Not reported30.266.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        30.2
        upper Limit
        66.9
        value
        48.4
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response \[VGPR\], Complete response \[CR\], or Stringent complete response \[sCR\]) per 2016 standard International Myeloma Working Group (IMWG) criteria.
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
NUMBER
population Description
All enrolled Phase 2 participants who received venetoclax and had active disease at baseline; primary efficacy endpoints were pre-specified for Phase 2 only, and are reported for all participants with available data
reporting Status
POSTED
time Frame
Response was assessed at Cycle 2, Day 1, and on Day 1 of every cycle thereafter; estimated median time on follow-up was 31.7 months
title
Phase 2: Overall Response Rate
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice