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NCT00483262 · OUTCOME

Best Response to Combination Treatment

Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma · Source last updated 2013-11-11

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
90% Confidence Interval
Time frame
10 months

What was measured

Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma

Analysis population: All patients included in analysis

Groups in this outcome

CCI779 Response Phase I

Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade

CCI779 Response Phase II

Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade

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

Analysis denominator · Participants

GroupSource count
CCI779 Response Phase I20
CCI779 Response Phase II43

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
CCI779 Response Phase I10Not reported228Not reported
CCI779 Response Phase II33Not reported2147Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    .02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    .28
    estimate Comment
    Response of PR or better
    group Description
    Phase I part of this phase I/II study
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    response rate of PR or better
    param Value
    0.10
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    0.47
    estimate Comment
    Response of PR or better
    group Description
    Phase II part of this phase I/II study.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    response rate of PR or better
    param Value
    0.33
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    .02
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    .28
    estimate Comment
    Response of PR or better
    group Description
    Phase I part of this phase I/II study
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    response rate of PR or better
    param Value
    0.10
    tested Non Inferiority
    false
  2. ci Lower Limit
    0.21
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    0.47
    estimate Comment
    Response of PR or better
    group Description
    Phase II part of this phase I/II study.
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    response rate of PR or better
    param Value
    0.33
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        28
        value
        10
      2. group Id
        OG001
        lower Limit
        21
        upper Limit
        47
        value
        33
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Response rate of PR or better to the combination treatment of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma
dispersion Type
90% Confidence Interval
groups
  1. description
    Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade
    id
    OG000
    title
    CCI779 Response Phase I
  2. description
    Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade
    id
    OG001
    title
    CCI779 Response Phase II
param Type
NUMBER
population Description
All patients included in analysis
reporting Status
POSTED
time Frame
10 months
title
Best Response to Combination Treatment
type
PRIMARY
unit Of Measure
percentage of patients

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

Preserved source evidence · Not medical advice