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NCT00478218 · OUTCOME

Progression-free Survival (PFS)

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2011-08-31

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
up to 5 years

What was measured

PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.\> Progression was defined as any one or more of the following:\> An increase of 25% from lowest confirmed response in:\> * Serum M-component (absolute increase \>= 0.5g/dl)\> * Urine M-component (absolute increase \>= 200mg/24hour\> * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl\> * Bone marrow plasma cell percentage (absolute increase of \>=10%)

Groups in this outcome

LCD (Cyclophosphamide 300 mg/m^2)

Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

LCD (Cyclophosphamide 300 mg)

Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22

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

Analysis denominator · Participants

GroupSource count
LCD (Cyclophosphamide 300 mg/m^2)34
LCD (Cyclophosphamide 300 mg)19

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
LCD (Cyclophosphamide 300 mg/m^2)27Not reported1432.6Not reported
LCD (Cyclophosphamide 300 mg)NANot reportedNANAThe median PFS for group 2 has not been attained
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14
        upper Limit
        32.6
        value
        27
      2. comment
        The median PFS for group 2 has not been attained
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      19
    units
    Participants
description
PFS was defined as the time from registration to progression or death due to any cause. The median PFS with 95%CI was estimated using the Kaplan Meier method.\> Progression was defined as any one or more of the following:\> An increase of 25% from lowest confirmed response in:\> * Serum M-component (absolute increase \>= 0.5g/dl)\> * Urine M-component (absolute increase \>= 200mg/24hour\> * Difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl\> * Bone marrow plasma cell percentage (absolute increase of \>=10%)
dispersion Type
95% Confidence Interval
groups
  1. description
    Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m\^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
    id
    OG000
    title
    LCD (Cyclophosphamide 300 mg/m^2)
  2. description
    Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
    id
    OG001
    title
    LCD (Cyclophosphamide 300 mg)
param Type
MEDIAN
reporting Status
POSTED
time Frame
up to 5 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice