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NCT02761187 · OUTCOME

Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
At Baseline

What was measured

ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L).

Analysis population: All Enrolled Population included all participants who signed informed consent. Overall number of participants are the number of participants available for analysis.

Groups in this outcome

NDMM

Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).

RRMM

Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (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
NDMM1761
RRMM1440

Reported measurements

ISS Stage I
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM395Not reportedNot reportedNot reportedNot reported
RRMM236Not reportedNot reportedNot reportedNot reported
ISS Stage II
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM387Not reportedNot reportedNot reportedNot reported
RRMM267Not reportedNot reportedNot reportedNot reported
ISS Stage III
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM520Not reportedNot reportedNot reportedNot reported
RRMM297Not reportedNot reportedNot reportedNot reported
ISS Not Available
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM138Not reportedNot reportedNot reportedNot reported
RRMM376Not reportedNot reportedNot reportedNot reported
ISS Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM321Not reportedNot reportedNot reportedNot reported
RRMM264Not reportedNot reportedNot reportedNot reported
R-ISS Stage I
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM127Not reportedNot reportedNot reportedNot reported
RRMM40Not reportedNot reportedNot reportedNot reported
R-ISS Stage II
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM319Not reportedNot reportedNot reportedNot reported
RRMM145Not reportedNot reportedNot reportedNot reported
R-ISS Stage III
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM76Not reportedNot reportedNot reportedNot reported
RRMM24Not reportedNot reportedNot reportedNot reported
R-ISS Not available
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM69Not reportedNot reportedNot reportedNot reported
RRMM285Not reportedNot reportedNot reportedNot reported
R-ISS Missing
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
NDMM1170Not reportedNot reportedNot reportedNot reported
RRMM946Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        395
      2. group Id
        OG001
        value
        236
    title
    ISS Stage I
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        387
      2. group Id
        OG001
        value
        267
    title
    ISS Stage II
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        520
      2. group Id
        OG001
        value
        297
    title
    ISS Stage III
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        138
      2. group Id
        OG001
        value
        376
    title
    ISS Not Available
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        321
      2. group Id
        OG001
        value
        264
    title
    ISS Missing
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        127
      2. group Id
        OG001
        value
        40
    title
    R-ISS Stage I
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        319
      2. group Id
        OG001
        value
        145
    title
    R-ISS Stage II
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        76
      2. group Id
        OG001
        value
        24
    title
    R-ISS Stage III
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        69
      2. group Id
        OG001
        value
        285
    title
    R-ISS Not available
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1170
      2. group Id
        OG001
        value
        946
    title
    R-ISS Missing
denoms
  1. counts
    1. group Id
      OG000
      value
      1761
    2. group Id
      OG001
      value
      1440
    units
    Participants
description
ISS disease stages were defined as I:low risk, β2-Microglobulin\<3.5mg/L, albumin≥3.5g/dL, II:not stage I or III, III:high risk,β2-Microglobulin≥5.5mg/L). R-ISS is based on ISS, chromosomal abnormalities (CA), and lactate dehydrogenase (LDH). R-ISS disease stages were defined as I: ISS Stage I and standard risk CA by FISH and normal LDH (i.e. \<=300 U/L), II: Neither R-ISS Stage I nor Stage III, III: ISS Stage III and either high risk CA by FISH or high LDH (i.e. \>300 U/L).
groups
  1. description
    Participants newly diagnosed with MM within 3 months from initiation of treatment were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
    id
    OG000
    title
    NDMM
  2. description
    Participants diagnosed with RRMM who previously received 1 to 3 prior lines of therapy were enrolled for 3 years, and followed for at least 2 years, until death, or the end of the study, whichever comes first (up to approximately 5 years).
    id
    OG001
    title
    RRMM
param Type
COUNT_OF_PARTICIPANTS
population Description
All Enrolled Population included all participants who signed informed consent. Overall number of participants are the number of participants available for analysis.
reporting Status
POSTED
time Frame
At Baseline
title
Number of Participants Evaluated for International Staging System (ISS)/ Revised (R)-ISS Stage
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice