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NCT02761187 · OUTCOME

Overall Survival (OS)

An Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Participants · Source last updated 2025-02-24

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
Baseline up to 5 years

What was measured

Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.

Analysis population: All Enrolled Population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.

Groups in this outcome

1st Line of Therapy

The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

2nd Line of Therapy

The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

3rd Line of Therapy

The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

4th Line of Therapy

The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

>4th Line of Therapy

The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).

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

Analysis denominator · Participants

GroupSource count
1st Line of Therapy1790
2nd Line of Therapy1331
3rd Line of Therapy1050
4th Line of Therapy739
>4th Line of Therapy453

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
1st Line of TherapyNANot reportedNANAMedian and 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events of death.
2nd Line of Therapy47.67Not reported45.34NAThe upper limit of CI was not estimable due to an insufficient number of participants with events of death.
3rd Line of Therapy32.07Not reported26.8439.56Not reported
4th Line of Therapy20.60Not reported17.5123.36Not reported
>4th Line of Therapy13.44Not reported10.9115.90Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and 95% confidence interval (CI) was not estimable due to an insufficient number of participants with events of death.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper limit of CI was not estimable due to an insufficient number of participants with events of death.
        group Id
        OG001
        lower Limit
        45.34
        upper Limit
        NA
        value
        47.67
      3. group Id
        OG002
        lower Limit
        26.84
        upper Limit
        39.56
        value
        32.07
      4. group Id
        OG003
        lower Limit
        17.51
        upper Limit
        23.36
        value
        20.60
      5. group Id
        OG004
        lower Limit
        10.91
        upper Limit
        15.90
        value
        13.44
denoms
  1. counts
    1. group Id
      OG000
      value
      1790
    2. group Id
      OG001
      value
      1331
    3. group Id
      OG002
      value
      1050
    4. group Id
      OG003
      value
      739
    5. group Id
      OG004
      value
      453
    units
    Participants
description
Overall Survival was defined as the number of months from the index regimen start date within each line of therapy, starting with the line during study entry, until the date of death. The Kaplan Meier estimates was used for the analysis.
dispersion Type
95% Confidence Interval
groups
  1. description
    The most common treatment regimens prescribed in participants treated in 1st line of therapy were PI+IMiD, PI+AA, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG000
    title
    1st Line of Therapy
  2. description
    The most common treatment regimens prescribed in participants treated in 2nd line of therapy were PI+IMiD, IMiD, and PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG001
    title
    2nd Line of Therapy
  3. description
    The most common treatment regimens prescribed in participants treated in 3rd line of therapy were IMiD, PI+IMiD, and mAB+IMiD treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG002
    title
    3rd Line of Therapy
  4. description
    The most common treatment regimens prescribed in participants treated in 4th line of therapy were mAb, mAb+IMiD, and mAB+PI treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG003
    title
    4th Line of Therapy
  5. description
    The most common treatment regimens prescribed in participants treated in \>4th line of therapy were mAb, PI, and IMiD+AA treatment as part of their index regimen while enrolled in the study and were observed until study discontinuation, death or end of study (up to approximately 5 years).
    id
    OG004
    title
    >4th Line of Therapy
param Type
MEDIAN
population Description
All Enrolled Population, included all participants who signed the inform consent form, out of which 990 participants were excluded during the final analysis due to concerns around robustness of data. The data is reported as per the known line of therapies. Overall number of participants analyzed is the number of participants available for analysis.
reporting Status
POSTED
time Frame
Baseline up to 5 years
title
Overall Survival (OS)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice