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NCT01794520 · OUTCOME

Phase 1: 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 8.1 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 2011 International Myeloma Working Group (IMWG) criteria.

Analysis population: All enrolled Phase 1 participants who had active disease at baseline and received venetoclax

Groups in this outcome

Phase 1: Venetoclax 300 mg

Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1: Venetoclax 600 mg

Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1: Venetoclax 900 mg

Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1: Venetoclax 1200 mg

Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1 Safety Expansion: Venetoclax 1200 mg

Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.

Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg

Participants with t(11;14) translocation multiple myeloma 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 1: Venetoclax 300 mg6
Phase 1: Venetoclax 600 mg9
Phase 1: Venetoclax 900 mg6
Phase 1: Venetoclax 1200 mg9
Phase 1 Safety Expansion: Venetoclax 1200 mg36
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg20

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1: Venetoclax 300 mg0Not reported0.045.9Not reported
Phase 1: Venetoclax 600 mg11.1Not reported0.348.2Not reported
Phase 1: Venetoclax 900 mg16.7Not reported0.464.1Not reported
Phase 1: Venetoclax 1200 mg0Not reported0.033.6Not reported
Phase 1 Safety Expansion: Venetoclax 1200 mg36.1Not reported20.853.8Not reported
Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg65.0Not reported40.884.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        45.9
        value
        0
      2. group Id
        OG001
        lower Limit
        0.3
        upper Limit
        48.2
        value
        11.1
      3. group Id
        OG002
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        33.6
        value
        0
      5. group Id
        OG004
        lower Limit
        20.8
        upper Limit
        53.8
        value
        36.1
      6. group Id
        OG005
        lower Limit
        40.8
        upper Limit
        84.6
        value
        65.0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      36
    6. group Id
      OG005
      value
      20
    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 2011 International Myeloma Working Group (IMWG) criteria.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants in the dose-escalation cohort received 300 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG000
    title
    Phase 1: Venetoclax 300 mg
  2. description
    Participants in the dose-escalation cohort received 600 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG001
    title
    Phase 1: Venetoclax 600 mg
  3. description
    Participants in the dose-escalation cohort received 900 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG002
    title
    Phase 1: Venetoclax 900 mg
  4. description
    Participants in the dose-escalation cohort received 1200 mg of venetoclax daily on Days 1 -21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG003
    title
    Phase 1: Venetoclax 1200 mg
  5. description
    Participants in the safety expansion cohort received 1200 mg of venetoclax daily on Days 1 - 21 of each cycle after a 2-week lead-in period, during which venetoclax doses were increased weekly.
    id
    OG004
    title
    Phase 1 Safety Expansion: Venetoclax 1200 mg
  6. description
    Participants with t(11;14) translocation multiple myeloma 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
    OG005
    title
    Phase 1 Combination: Venetoclax 800 mg/Dexamethasone 20 or 40 mg
param Type
NUMBER
population Description
All enrolled Phase 1 participants who had active disease at baseline and received venetoclax
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 8.1 months
title
Phase 1: Overall Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice