Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00424047 · OUTCOME

Kaplan-Meier Estimate of Time to Tumor Progression (TTP)

A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to cut-off date of 03 August 2005; up to 24 months

What was measured

Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.

Analysis population: Intent to treat included all participants who were randomized.

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.

Placebo Plus Dexamethasone

Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide Plus Dexamethasone176
Placebo Plus Dexamethasone175

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone52.1Not reported40.9NAUnable to provide as data not yet estimable
Placebo Plus Dexamethasone20.1Not reported16.620.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.240
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.438
    estimate Comment
    Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.324
    statistical Comment
    The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.240
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.438
    estimate Comment
    Based on a proportional hazards model comparing the hazard functions associated with the treatment groups (Lenalidomide/Dex:Placebo/Dexamethasone)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.324
    statistical Comment
    The p-value is based on an unstratified log rank test of survival curve differences between the treatment groups
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Unable to provide as data not yet estimable
        group Id
        OG000
        lower Limit
        40.9
        upper Limit
        NA
        value
        52.1
      2. group Id
        OG001
        lower Limit
        16.6
        upper Limit
        20.7
        value
        20.1
denoms
  1. counts
    1. group Id
      OG000
      value
      176
    2. group Id
      OG001
      value
      175
    units
    Participants
description
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    OG000
    title
    Lenalidomide Plus Dexamethasone
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
    id
    OG001
    title
    Placebo Plus Dexamethasone
param Type
MEDIAN
population Description
Intent to treat included all participants who were randomized.
reporting Status
POSTED
time Frame
From randomization up to cut-off date of 03 August 2005; up to 24 months
title
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
type
PRIMARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice