Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02252172 · OUTCOME

Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma · Source last updated 2025-10-20

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

Measure
LEAST_SQUARES_MEAN
Unit
Score on scale
Interval / dispersion
95% Confidence Interval
Time frame
Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days)

What was measured

EQ-5D-5L was a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale was designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.

Analysis population: ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' signifies number of participants analyzed at specified timepoints.

Groups in this outcome

Lenalidomide + Dexamethasone (Rd)

Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).

Daratumumab + Lenalidomide + Dexamethasone (DRd)

Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

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

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)286
Daratumumab + Lenalidomide + Dexamethasone (DRd)301

Reported measurements

Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)286
Daratumumab + Lenalidomide + Dexamethasone (DRd)301
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)2.1Not reported0.34Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)4.2Not reported2.36Not reported
Cycle 6 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)252
Daratumumab + Lenalidomide + Dexamethasone (DRd)287
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)4.8Not reported2.86.8Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)7.6Not reported5.89.5Not reported
Cycle 9 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)221
Daratumumab + Lenalidomide + Dexamethasone (DRd)267
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)7Not reported59.1Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)9.6Not reported7.711.5Not reported
Cycle 12 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)227
Daratumumab + Lenalidomide + Dexamethasone (DRd)261
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)3.6Not reported1.65.7Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)9.4Not reported7.411.3Not reported
Cycle 18 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)180
Daratumumab + Lenalidomide + Dexamethasone (DRd)242
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)5.4Not reported3.27.6Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)7.4Not reported5.49.4Not reported
Cycle 24 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)154
Daratumumab + Lenalidomide + Dexamethasone (DRd)227
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)4.3Not reported26.7Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)7Not reported59Not reported
Cycle 30 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)133
Daratumumab + Lenalidomide + Dexamethasone (DRd)198
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)4.6Not reported2.17Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)6.9Not reported4.89.1Not reported
Cycle 36 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)115
Daratumumab + Lenalidomide + Dexamethasone (DRd)195
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)4.9Not reported2.37.5Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)8.1Not reported610.2Not reported
Cycle 42 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)99
Daratumumab + Lenalidomide + Dexamethasone (DRd)178
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)4.6Not reported1.87.3Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)5.6Not reported3.47.8Not reported
Cycle 48 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)79
Daratumumab + Lenalidomide + Dexamethasone (DRd)162
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)5.5Not reported2.48.5Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)6.7Not reported4.59Not reported
Cycle 54 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)64
Daratumumab + Lenalidomide + Dexamethasone (DRd)141
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)3.4Not reported0.16.7Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)5.8Not reported3.48.2Not reported
Cycle 60 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)44
Daratumumab + Lenalidomide + Dexamethasone (DRd)112
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)5.8Not reported1.99.6Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)5.2Not reported2.67.8Not reported
Cycle 66 Day 1

Analysis denominator · Participants

GroupSource count
Lenalidomide + Dexamethasone (Rd)26
Daratumumab + Lenalidomide + Dexamethasone (DRd)74
Values in Score on scale · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)6.9Not reported211.8Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)5.6Not reported2.58.7Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    -0.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.5
    group Description
    Cycle 3 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1176
    param Type
    Least Square Mean Difference
    param Value
    2
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    0.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.4
    group Description
    Cycle 6 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0336
    param Type
    Least Square Mean Difference
    param Value
    2.8
    statistical Method
    Mixed Models Analysis
  3. ci Lower Limit
    -0.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.3
    group Description
    Cycle 9 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0653
    param Type
    Least Square Mean Difference
    param Value
    2.6
    statistical Method
    Mixed Models Analysis
  4. ci Lower Limit
    3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.5
    group Description
    Cycle 12 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0000
    param Type
    Least Square Mean Difference
    param Value
    5.8
    statistical Method
    Mixed Models Analysis
  5. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.8
    group Description
    Cycle 18 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1805
    param Type
    Least Square Mean Difference
    param Value
    2
    statistical Method
    Mixed Models Analysis
  6. ci Lower Limit
    -0.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.7
    group Description
    Cycle 24 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0783
    param Type
    Least Square Mean Difference
    param Value
    2.7
    statistical Method
    Mixed Models Analysis
  7. ci Lower Limit
    -0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.5
    group Description
    Cycle 30 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1422
    param Type
    Least Square Mean Difference
    param Value
    2.4
    statistical Method
    Mixed Models Analysis
  8. ci Lower Limit
    -0.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.5
    group Description
    Cycle 36 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0575
    param Type
    Least Square Mean
    param Value
    3.2
    statistical Method
    Least Square Mean Difference
  9. ci Lower Limit
    -2.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.5
    group Description
    Cycle 42 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.5339
    param Type
    Least Square Mean Difference
    param Value
    1.1
    statistical Method
    Mixed Models Analysis
  10. ci Lower Limit
    -2.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5
    group Description
    Cycle 48 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.5015
    param Type
    Least Square Mean Difference
    param Value
    1.3
    statistical Method
    Mixed Models Analysis
  11. ci Lower Limit
    -1.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.3
    group Description
    Cycle 54 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.2512
    param Type
    Least Square Mean Difference
    param Value
    2.3
    statistical Method
    Mixed Models Analysis
  12. ci Lower Limit
    -5.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.1
    group Description
    Cycle 60 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.8246
    param Type
    Least Square Mean Difference
    param Value
    -0.5
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    -0.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.5
    group Description
    Cycle 3 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1176
    param Type
    Least Square Mean Difference
    param Value
    2
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    0.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.4
    group Description
    Cycle 6 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0336
    param Type
    Least Square Mean Difference
    param Value
    2.8
    statistical Method
    Mixed Models Analysis
  3. ci Lower Limit
    -0.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.3
    group Description
    Cycle 9 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0653
    param Type
    Least Square Mean Difference
    param Value
    2.6
    statistical Method
    Mixed Models Analysis
  4. ci Lower Limit
    3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.5
    group Description
    Cycle 12 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0000
    param Type
    Least Square Mean Difference
    param Value
    5.8
    statistical Method
    Mixed Models Analysis
  5. ci Lower Limit
    -0.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.8
    group Description
    Cycle 18 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1805
    param Type
    Least Square Mean Difference
    param Value
    2
    statistical Method
    Mixed Models Analysis
  6. ci Lower Limit
    -0.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.7
    group Description
    Cycle 24 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0783
    param Type
    Least Square Mean Difference
    param Value
    2.7
    statistical Method
    Mixed Models Analysis
  7. ci Lower Limit
    -0.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.5
    group Description
    Cycle 30 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.1422
    param Type
    Least Square Mean Difference
    param Value
    2.4
    statistical Method
    Mixed Models Analysis
  8. ci Lower Limit
    -0.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.5
    group Description
    Cycle 36 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0575
    param Type
    Least Square Mean
    param Value
    3.2
    statistical Method
    Least Square Mean Difference
  9. ci Lower Limit
    -2.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.5
    group Description
    Cycle 42 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.5339
    param Type
    Least Square Mean Difference
    param Value
    1.1
    statistical Method
    Mixed Models Analysis
  10. ci Lower Limit
    -2.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5
    group Description
    Cycle 48 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.5015
    param Type
    Least Square Mean Difference
    param Value
    1.3
    statistical Method
    Mixed Models Analysis
  11. ci Lower Limit
    -1.7
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.3
    group Description
    Cycle 54 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.2512
    param Type
    Least Square Mean Difference
    param Value
    2.3
    statistical Method
    Mixed Models Analysis
  12. ci Lower Limit
    -5.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.1
    group Description
    Cycle 60 Day 1
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.8246
    param Type
    Least Square Mean Difference
    param Value
    -0.5
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.3
        upper Limit
        4
        value
        2.1
      2. group Id
        OG001
        lower Limit
        2.3
        upper Limit
        6
        value
        4.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        286
      2. group Id
        OG001
        value
        301
      units
      Participants
    title
    Cycle 3 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.8
        upper Limit
        6.8
        value
        4.8
      2. group Id
        OG001
        lower Limit
        5.8
        upper Limit
        9.5
        value
        7.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        252
      2. group Id
        OG001
        value
        287
      units
      Participants
    title
    Cycle 6 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5
        upper Limit
        9.1
        value
        7
      2. group Id
        OG001
        lower Limit
        7.7
        upper Limit
        11.5
        value
        9.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        221
      2. group Id
        OG001
        value
        267
      units
      Participants
    title
    Cycle 9 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.6
        upper Limit
        5.7
        value
        3.6
      2. group Id
        OG001
        lower Limit
        7.4
        upper Limit
        11.3
        value
        9.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        227
      2. group Id
        OG001
        value
        261
      units
      Participants
    title
    Cycle 12 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.2
        upper Limit
        7.6
        value
        5.4
      2. group Id
        OG001
        lower Limit
        5.4
        upper Limit
        9.4
        value
        7.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        180
      2. group Id
        OG001
        value
        242
      units
      Participants
    title
    Cycle 18 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2
        upper Limit
        6.7
        value
        4.3
      2. group Id
        OG001
        lower Limit
        5
        upper Limit
        9
        value
        7
    denoms
    1. counts
      1. group Id
        OG000
        value
        154
      2. group Id
        OG001
        value
        227
      units
      Participants
    title
    Cycle 24 Day 1
  7. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        7
        value
        4.6
      2. group Id
        OG001
        lower Limit
        4.8
        upper Limit
        9.1
        value
        6.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        133
      2. group Id
        OG001
        value
        198
      units
      Participants
    title
    Cycle 30 Day 1
  8. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.3
        upper Limit
        7.5
        value
        4.9
      2. group Id
        OG001
        lower Limit
        6
        upper Limit
        10.2
        value
        8.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        115
      2. group Id
        OG001
        value
        195
      units
      Participants
    title
    Cycle 36 Day 1
  9. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        7.3
        value
        4.6
      2. group Id
        OG001
        lower Limit
        3.4
        upper Limit
        7.8
        value
        5.6
    denoms
    1. counts
      1. group Id
        OG000
        value
        99
      2. group Id
        OG001
        value
        178
      units
      Participants
    title
    Cycle 42 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.4
        upper Limit
        8.5
        value
        5.5
      2. group Id
        OG001
        lower Limit
        4.5
        upper Limit
        9
        value
        6.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        79
      2. group Id
        OG001
        value
        162
      units
      Participants
    title
    Cycle 48 Day 1
  11. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.1
        upper Limit
        6.7
        value
        3.4
      2. group Id
        OG001
        lower Limit
        3.4
        upper Limit
        8.2
        value
        5.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        64
      2. group Id
        OG001
        value
        141
      units
      Participants
    title
    Cycle 54 Day 1
  12. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.9
        upper Limit
        9.6
        value
        5.8
      2. group Id
        OG001
        lower Limit
        2.6
        upper Limit
        7.8
        value
        5.2
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      2. group Id
        OG001
        value
        112
      units
      Participants
    title
    Cycle 60 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      286
    2. group Id
      OG001
      value
      301
    units
    Participants
description
EQ-5D-5L was a standardized, participant-rated questionnaire to assess health-related quality of life. The EQ-5D-5L includes 2 components: the EQ-5D-5L health state profile (descriptive system) and the EQ-5D-5L Visual Analog Scale. The Visual Analogue Scale was designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).
    id
    OG000
    title
    Lenalidomide + Dexamethasone (Rd)
  2. description
    Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
    id
    OG001
    title
    Daratumumab + Lenalidomide + Dexamethasone (DRd)
param Type
LEAST_SQUARES_MEAN
population Description
ITT population included all randomized participants. Here 'N' (overall number of participants analyzed) signifies number of participants who were evaluable for this outcome measure; 'n' signifies number of participants analyzed at specified timepoints.
reporting Status
POSTED
time Frame
Baseline (Day -24) and Day 1 of Cycles 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 and 66 (each Cycle of 28 days)
title
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS)
type
SECONDARY
unit Of Measure
Score on scale

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice