Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02633059 · OUTCOME

Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)

Idasanutlin, Ixazomib Citrate, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2024-09-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 6 months

What was measured

Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.

Groups in this outcome

Phase II and MTD

6 MTD and 16 phase II accruals

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 II and MTD22

Reported measurements

PR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II and MTD2Not reportedNot reportedNot reportedNot reported
SD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II and MTD6Not reportedNot reportedNot reportedNot reported
NA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II and MTD14Not reportedNot reportedNot reportedNot reported
CR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II and MTD0Not reportedNot reportedNot reportedNot reported
VGPR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II and MTD0Not reportedNot reportedNot reportedNot reported
sCR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase II and MTD0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    PR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    SD
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    NA
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    CR
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    VGPR
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    sCR
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    units
    Participants
description
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated.
groups
  1. description
    6 MTD and 16 phase II accruals
    id
    OG000
    title
    Phase II and MTD
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 6 months
title
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice