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NCT01891643 · OUTCOME

Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression

PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy) · Source last updated 2021-07-01

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

Measure
MEDIAN
Unit
ug/L
Interval / dispersion
Full Range
Time frame
From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months)

What was measured

Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection

Analysis population: All treated participants with measurements available at baseline and at cycle 3 day 1 of study therapy or at baseline and at the time of progression.

Groups in this outcome

E-Ld Cohort

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

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

Analysis denominator · Participants

GroupSource count
E-Ld Cohort13
Ld Cohort10

Reported measurements

From baseline to Cycle 3 day 1 of main study therapy

Analysis denominator · Participants

GroupSource count
E-Ld Cohort7
Ld Cohort4
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
E-Ld Cohort-3.51Not reported-6.9-0.6Not reported
Ld Cohort-4.08Not reported-15.1-1.6Not reported
From baseline to time of progression

Analysis denominator · Participants

GroupSource count
E-Ld Cohort3
Ld Cohort1
Values in ug/L · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
E-Ld Cohort-0.85Not reported-6.9-0.4Not reported
Ld Cohort-17.41Not reportedNANAOnly 1 participant analyzed
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.9
        upper Limit
        -0.6
        value
        -3.51
      2. group Id
        OG001
        lower Limit
        -15.1
        upper Limit
        -1.6
        value
        -4.08
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
      units
      Participants
    title
    From baseline to Cycle 3 day 1 of main study therapy
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -6.9
        upper Limit
        -0.4
        value
        -0.85
      2. comment
        Only 1 participant analyzed
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        -17.41
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      units
      Participants
    title
    From baseline to time of progression
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      10
    units
    Participants
description
Expression levels of the free form of soluble CS1 were analyzed at different timepoints from serum samples derived from peripheral blood collection
dispersion Type
Full Range
groups
  1. description
    Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG000
    title
    E-Ld Cohort
  2. description
    Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG001
    title
    Ld Cohort
param Type
MEDIAN
population Description
All treated participants with measurements available at baseline and at cycle 3 day 1 of study therapy or at baseline and at the time of progression.
reporting Status
POSTED
time Frame
From baseline (screening) to cycle 3 day 1 of the main study therapy (up to 64 days) and from baseline (screening) to time of progression (up to approximately 31 months)
title
Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression
type
SECONDARY
unit Of Measure
ug/L

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

Preserved source evidence · Not medical advice