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NCT02917941 · OUTCOME

Percentage of Participants With Very Good Partial Response (VGPR) or Better Response (Complete Response (CR) + VGPR)

A Study of Ixazomib Plus Lenalidomide and Dexamethasone in Adult Japanese Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2021-01-12

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 33 months

What was measured

Response was assessed using International Myeloma Working Group (IMWG) Criteria. CR was defined as negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.

Analysis population: Response-evaluable analysis set was defined as all full analysis set (FAS) participants with measurable disease at baseline, and at least one postbaseline response assessment.

Groups in this outcome

Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 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
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg32

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg50.0Not reported31.968.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.9
        upper Limit
        68.1
        value
        50.0
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Response was assessed using International Myeloma Working Group (IMWG) Criteria. CR was defined as negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow. VGPR was defined as serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 hours.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 plus lenalidomide 25 mg, capsule, orally, once daily on Days 1 through 21 and dexamethasone 40 mg, tablet, orally on Days 1, 8, 15, and 22 of a 28-day cycle up to 32 cycles.
    id
    OG000
    title
    Ixazomib 4 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
param Type
NUMBER
population Description
Response-evaluable analysis set was defined as all full analysis set (FAS) participants with measurable disease at baseline, and at least one postbaseline response assessment.
reporting Status
POSTED
time Frame
Up to approximately 33 months
title
Percentage of Participants With Very Good Partial Response (VGPR) or Better Response (Complete Response (CR) + VGPR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice