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NCT01050790 · OUTCOME

Progression-free and Overall Survival

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma · Source last updated 2018-06-26

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
1 year to 2 years

What was measured

Survival and event-free survival curves (any event of fatality, relapse, acute or chronic GVHD) with Kaplan-Meier curves. The incidence curve for relapse - accounting for the competing risk of fatality - is plotted with step-wise curves. The R statistical software (version 2.15) was used for all time-to-event analyses, with the survival package used for survival curves, and the cmprsk package used for all competing risk curves. Results: The one-year survival rate is 93.3% (SE = 0.4%), and the two-year survival rate is 86.1% (SE = 0.9%).

Analysis population: The outcome measure data was collected up to one to two years post transplant.

Groups in this outcome

5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant

azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21

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

Analysis denominator · Participants

GroupSource count
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant17

Reported measurements

one- year survival rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant93.3Not reported92.5294.08Not reported
two-year survival rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant86.1Not reported84.3487.86Not reported
one-year relapse rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant12.5Not reported11.1313.87Not reported
two-year relapse rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant19.2Not reported17.0421.36Not reported
one-year event free survival rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant87.5Not reported86.1388.87Not reported
two-year event free survival rate
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant67.3Not reported64.1670.44Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        92.52
        upper Limit
        94.08
        value
        93.3
    title
    one- year survival rate
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        84.34
        upper Limit
        87.86
        value
        86.1
    title
    two-year survival rate
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.13
        upper Limit
        13.87
        value
        12.5
    title
    one-year relapse rate
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.04
        upper Limit
        21.36
        value
        19.2
    title
    two-year relapse rate
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.13
        upper Limit
        88.87
        value
        87.5
    title
    one-year event free survival rate
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        64.16
        upper Limit
        70.44
        value
        67.3
    title
    two-year event free survival rate
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Survival and event-free survival curves (any event of fatality, relapse, acute or chronic GVHD) with Kaplan-Meier curves. The incidence curve for relapse - accounting for the competing risk of fatality - is plotted with step-wise curves. The R statistical software (version 2.15) was used for all time-to-event analyses, with the survival package used for survival curves, and the cmprsk package used for all competing risk curves. Results: The one-year survival rate is 93.3% (SE = 0.4%), and the two-year survival rate is 86.1% (SE = 0.9%).
dispersion Type
95% Confidence Interval
groups
  1. description
    azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21
    id
    OG000
    title
    5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant
param Type
NUMBER
population Description
The outcome measure data was collected up to one to two years post transplant.
reporting Status
POSTED
time Frame
1 year to 2 years
title
Progression-free and Overall Survival
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice