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NCT02011113 · OUTCOME

Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria

Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-11-01

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

Measure
NUMBER
Unit
percentage of participants responding
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.

What was measured

Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Analysis population: Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.

Groups in this outcome

Pomalidomide Plus Dexamethasone

Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Dexamethasone36

Reported measurements

Source class 1
Values in percentage of participants responding · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Dexamethasone25.0Not reported10.85539.145Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0027
    p Value Comment
    Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)
    statistical Method
    Binomial test for dichotomized response
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0027
    p Value Comment
    Based on one sample binomial test for dichotomized response proportion against the null hypothesis(H0: p = 0.1)
    statistical Method
    Binomial test for dichotomized response
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        10.855
        upper Limit
        39.145
        value
        25.0
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Myeloma response was defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    OG000
    title
    Pomalidomide Plus Dexamethasone
param Type
NUMBER
population Description
Efficacy Evaluable Population includes all participants who met eligibility criteria, took at least one dose of study medication, and had a baseline and a post-baseline efficacy assessment.
reporting Status
POSTED
time Frame
From the first dose until the data cut-off date of 03 Sept 2014; Maximum time in follow-up was 36.0 weeks.
title
Myeloma Response Rate Based on the International Myeloma Working Group (IMWG) Uniform Response Criteria
type
PRIMARY
unit Of Measure
percentage of participants responding

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

Preserved source evidence · Not medical advice