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NCT02119468 · OUTCOME

Clinical Benefit Response Rate at the Recommended Phase II Dose (RP2D)

Ixazomib Plus Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2024-03-15

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
From the initial treatment up to 24 months

What was measured

Clinical benefit response rate is calculated as the percent of evaluable patients that have confirmed stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR), partial remission (PR), minimal response (MR) or stable disease (SD) per modified IMWG criteria. The exact 95% confidence intervals are calculated for the estimate.

Analysis population: Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).

Groups in this outcome

Dose Level #2 (4mg MLN9708)

Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Dose Level #2 (4mg MLN9708)25

Reported measurements

Source class 1
Values in Percentage of Participants (%) · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level #2 (4mg MLN9708)76Not reported54.990.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        54.9
        upper Limit
        90.6
        value
        76
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Clinical benefit response rate is calculated as the percent of evaluable patients that have confirmed stringent complete remission (sCR), complete remission (CR), very good partial remission (VGPR), partial remission (PR), minimal response (MR) or stable disease (SD) per modified IMWG criteria. The exact 95% confidence intervals are calculated for the estimate.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 4mg ixazomib citrate (MLN9708) orally on days 1, 8, and 15; dexamethasone orally on days 1, 8, 15, and 22; and pomalidomide orally on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Dose Level #2 (4mg MLN9708)
param Type
NUMBER
population Description
Patients received 4 mg MLN9708, 4mg pomalidomide, and 40 mg dexamethasone (RP2D).
reporting Status
POSTED
time Frame
From the initial treatment up to 24 months
title
Clinical Benefit Response Rate at the Recommended Phase II Dose (RP2D)
type
SECONDARY
unit Of Measure
Percentage of Participants (%)

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

Preserved source evidence · Not medical advice