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NCT01556438 · OUTCOME

Number of Participants With Tumor Response (Tumor Response Rate)

Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma · Source last updated 2019-03-20

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
Baseline to disease progression (up to 421 days)

What was measured

Stringent Complete Response- Complete response in addition to normal free light chain ration and no clonal cells in bone marrow. Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow. Very Good Partial Response-more than 90% decrease in mp and urine protein. Partial Response- over 50% decrease in serum mp. Stable Disease- less than 25 percent decrease of monoclonal protein. Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp.

Analysis population: All participants who received at least 1 dose of study drug.

Groups in this outcome

100 mg Tabalumab+BTZ IV+Dex

Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.

300 mg Tabalumab+ IV BTZ +Dex

Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).

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+BTZ IV+Dex4
300 mg Tabalumab+ IV BTZ +Dex12

Reported measurements

Numbers of Responders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex4Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex5Not reportedNot reportedNot reportedNot reported
Stringent Complete Response (sCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex0Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex0Not reportedNot reportedNot reportedNot reported
Complete Response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex0Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex0Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex2Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex1Not reportedNot reportedNot reportedNot reported
Partial Response(PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex2Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex4Not reportedNot reportedNot reportedNot reported
Stable Disease(SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex0Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex2Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
100 mg Tabalumab+BTZ IV+Dex0Not reportedNot reportedNot reportedNot reported
300 mg Tabalumab+ IV BTZ +Dex3Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Numbers of Responders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Stringent Complete Response (sCR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete Response (CR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Very Good Partial Response (VGPR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
    title
    Partial Response(PR)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Stable Disease(SD)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    Progressive Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      12
    units
    Participants
description
Stringent Complete Response- Complete response in addition to normal free light chain ration and no clonal cells in bone marrow. Complete Response- no monoclonal protein (mp) in blood, no serum or urine mp, less than 5% plasma cells in bone marrow. Very Good Partial Response-more than 90% decrease in mp and urine protein. Partial Response- over 50% decrease in serum mp. Stable Disease- less than 25 percent decrease of monoclonal protein. Progressive Disease- 25% increase compared to lowest value of serum mp, urine mp, no measurable mp.
groups
  1. description
    Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
    id
    OG000
    title
    100 mg Tabalumab+BTZ IV+Dex
  2. description
    Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
    id
    OG001
    title
    300 mg Tabalumab+ IV BTZ +Dex
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Baseline to disease progression (up to 421 days)
title
Number of Participants With Tumor Response (Tumor Response Rate)
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice