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NCT01602224 · OUTCOME

Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR])

A Study of Tabalumab (LY2127399) in Participants With Previously Treated Multiple Myeloma (MM) · Source last updated 2019-10-08

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months)

What was measured

Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,\<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR-\>50% decrease in serum MP;SD-\<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp.

Analysis population: All randomized participants.

Groups in this outcome

100 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

300 mg Tabalumab+Dexamethasone+Bortezomib

Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

Placebo Comparator: Placebo + Dexamethasone + Bortezombib

Placebo administered once IV on Day 1 every 21 days for 8 cycles.Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.

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

Analysis denominator · Participants

GroupSource count
100 mg Tabalumab+Dexamethasone+Bortezomib74
300 mg Tabalumab+Dexamethasone+Bortezomib74
Placebo Comparator: Placebo + Dexamethasone + Bortezombib72

Reported measurements

Stringent Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib1Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib0Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib2Not reportedNot reportedNot reportedNot reported
Complete Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib10Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib4Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib4Not reportedNot reportedNot reportedNot reported
Very Good Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib10Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib16Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib9Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib23Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib23Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib29Not reportedNot reportedNot reportedNot reported
Minimal Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib6Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib8Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib6Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib14Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib10Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib12Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+Dexamethasone+Bortezomib6Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+Dexamethasone+Bortezomib7Not reportedNot reportedNot reportedNot reported
Placebo Comparator: Placebo + Dexamethasone + Bortezombib6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Num Sides
    TWO_SIDED
    group Description
    100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.401
    param Type
    Odds Ratio (OR)
    param Value
    1.98
    statistical Method
    Regression, Logistic
  2. ci Num Sides
    TWO_SIDED
    group Description
    300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.455
    param Type
    Odds Ratio (OR)
    param Value
    1.84
    statistical Method
    Regression, Logistic
  3. ci Num Sides
    TWO_SIDED
    group Description
    100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.419
    param Type
    Odds Ratio (OR)
    param Value
    1.90
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Description
    100 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.401
    param Type
    Odds Ratio (OR)
    param Value
    1.98
    statistical Method
    Regression, Logistic
  2. ci Num Sides
    TWO_SIDED
    group Description
    300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only tabalumab odds ratio compared to placebo.
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.455
    param Type
    Odds Ratio (OR)
    param Value
    1.84
    statistical Method
    Regression, Logistic
  3. ci Num Sides
    TWO_SIDED
    group Description
    100 mg Tabalumab+Dexamethasone+Bortezomib and 300 mg Tabalumab+Dexamethasone+Bortezomib compared with Placebo Comparator: Placebo + Dexamethasone + Bortezombib, only compared to placebo.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.419
    param Type
    Odds Ratio (OR)
    param Value
    1.90
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    Stringent Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        4
    title
    Complete Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        9
    title
    Very Good Partial Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        23
      3. group Id
        OG002
        value
        29
    title
    Partial Response
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        6
    title
    Minimal Response
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        12
    title
    Stable Disease
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
      3. group Id
        OG002
        value
        6
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      74
    2. group Id
      OG001
      value
      74
    3. group Id
      OG002
      value
      72
    units
    Participants
description
Response categories in order of decreasing quality are: Stringent Complete Response(sCR),Complete Response(CR), Very Good Partial Response(VGPR),Partial Response(PR),Minimal Response(MR),Stable Disease(SD), or Progressive Disease(PD), according to the International Uniform Response Criteria for Multiple Myeloma.SCR:normal free light chain ration and no clonal cells in bone marrow;CR-no monoclonal protein(mp) in blood, no serum/urine,\<5% plasma cells in bone marrow; VGPR-more than 90% decrease in mp and urine protein; PR-\>50% decrease in serum MP;SD-\<25% decrease in mp; PD-25% increase compared to lowest value of serum mp, urine mp and no measurable mp.
groups
  1. description
    Tabalumab 100 milligram (mg) administered once intravenously (IV) over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 milligram per square meter (mg/m\^2) administered once subcutaneously (SQ) on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG000
    title
    100 mg Tabalumab+Dexamethasone+Bortezomib
  2. description
    Tabalumab 300 mg administered once IV over 30 minutes on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG001
    title
    300 mg Tabalumab+Dexamethasone+Bortezomib
  3. description
    Placebo administered once IV on Day 1 every 21 days for 8 cycles.Placebo administered once IV on Day 1 every 21 days for 8 cycles. Dexamethasone 20 mg administered once orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 every 21 days for 8 cycles. Bortezomib 1.3 mg/m\^2 administered once SQ on Days 1, 4, 8 and 11 every 21 days for 8 cycles.
    id
    OG002
    title
    Placebo Comparator: Placebo + Dexamethasone + Bortezombib
param Type
NUMBER
population Description
All randomized participants.
reporting Status
POSTED
time Frame
Baseline to Objective Disease Progression or Initiation of New Cancer Treatment (up to 28 Months)
title
Number of Participants With a Given Best Objective Myeloma Response (Quality of Response [QoR])
type
SECONDARY
unit Of Measure
participants

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Preserved source evidence · Not medical advice