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NCT03312530 · OUTCOME

Duration of Response (DOR) as Determined by the Investigator Using IMWG Response Criteria

A Study of Cobimetinib Administered as Single Agent and in Combination With Venetoclax, With or Without Atezolizumab, in Participants With Relapsed and Refractory Multiple Myeloma · Source last updated 2023-02-28

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
Time from the first observation of partial response (PR) or better to the time of disease progression (up to approximately 3 years, 7 months)

What was measured

DOR was applicable to participants who achieved at least a PR, and was measured from the first observation of PR or better to the time of disease progression.

Analysis population: The safety evaluable population included all participants who received any amount of study drug.

Groups in this outcome

Safety Run-In: Cobimetinib + Venetoclax

Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.

Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab

Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.

B: Cobimetinib + Venetoclax

Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

C: Cobimetinib + Venetoclax + Atezolizumab

Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.

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

Analysis denominator · Participants

GroupSource count
Safety Run-In: Cobimetinib + Venetoclax1
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab2
B: Cobimetinib + Venetoclax5
C: Cobimetinib + Venetoclax + Atezolizumab4

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety Run-In: Cobimetinib + Venetoclax11.5Not reportedNANANA = not estimable, could not be calculated due to too few events.
Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab4.9Not reported2.3NANA = not estimable, could not be calculated due to too few events.
B: Cobimetinib + Venetoclax15.2Not reported1.9NANA = not estimable, could not be calculated due to too few events.
C: Cobimetinib + Venetoclax + AtezolizumabNANot reported1.9NANA = not estimable, could not be calculated due to too few events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = not estimable, could not be calculated due to too few events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        11.5
      2. comment
        NA = not estimable, could not be calculated due to too few events.
        group Id
        OG001
        lower Limit
        2.3
        upper Limit
        NA
        value
        4.9
      3. comment
        NA = not estimable, could not be calculated due to too few events.
        group Id
        OG002
        lower Limit
        1.9
        upper Limit
        NA
        value
        15.2
      4. comment
        NA = not estimable, could not be calculated due to too few events.
        group Id
        OG003
        lower Limit
        1.9
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      4
    units
    Participants
description
DOR was applicable to participants who achieved at least a PR, and was measured from the first observation of PR or better to the time of disease progression.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses, in 28-day cycles, to identify the dose level with acceptable safety.
    id
    OG000
    title
    Safety Run-In: Cobimetinib + Venetoclax
  2. description
    Participants received cobimetinib (on Day 1-21) plus venetoclax (on Day 1-28) at escalated doses and atezolizumab (on Day 1 and Day 15) at a fixed dose of 840 mg IV, in 28-day cycles, to identify the dose level with acceptable safety.
    id
    OG001
    title
    Safety Run-In: Cobimetinib + Venetoclax + Atezolizumab
  3. description
    Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG002
    title
    B: Cobimetinib + Venetoclax
  4. description
    Participants received cobimetinib PO daily on Days 1-21 of each 28-day cycle plus venetoclax PO daily on Days 1-28 of each 28-day cycle, at the dose level identified in the safety run-in phase plus atezolizumab IV infusion at a fixed dose of 840 mg on Day 1 and Day 15 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, death, participant or physician decision to withdraw, or pregnancy, whichever occurred first.
    id
    OG003
    title
    C: Cobimetinib + Venetoclax + Atezolizumab
param Type
MEDIAN
population Description
The safety evaluable population included all participants who received any amount of study drug.
reporting Status
POSTED
time Frame
Time from the first observation of partial response (PR) or better to the time of disease progression (up to approximately 3 years, 7 months)
title
Duration of Response (DOR) as Determined by the Investigator Using IMWG Response Criteria
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice