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NCT03567616 · OUTCOME

Overall Response Rate (ORR)

A Study of Venetoclax in Combination With Pomalidomide and Dexamethasone in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2021-06-30

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
Approximately 15 months

What was measured

ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level \< 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours.

Analysis population: Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

Groups in this outcome

Participants Positive for t(11;14) Translocation

Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

Participants Negative for t(11;14) Translocation

Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

All Participants

Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)

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

Analysis denominator · Participants

GroupSource count
Participants Positive for t(11;14) Translocation3
Participants Negative for t(11;14) Translocation5
All Participants8

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Participants Positive for t(11;14) Translocation66.7Not reported9.499.2Not reported
Participants Negative for t(11;14) Translocation60.0Not reported14.794.7Not reported
All Participants62.5Not reported24.591.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        9.4
        upper Limit
        99.2
        value
        66.7
      2. group Id
        OG001
        lower Limit
        14.7
        upper Limit
        94.7
        value
        60.0
      3. group Id
        OG002
        lower Limit
        24.5
        upper Limit
        91.5
        value
        62.5
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      8
    units
    Participants
description
ORR is defined as the percentage of participants experiencing a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using the International Myeloma Working Group (IMWG) 2016 criteria for disease response and progression. CR= negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow; sCR= CR + normal serum free light chain (FLC) ratio and absence of clonal cells in bone marrow; VGPR= serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level + urine M-protein level \< 100 mg per 24 hours; PR= ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg per 24 hours.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants positive for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    id
    OG000
    title
    Participants Positive for t(11;14) Translocation
  2. description
    Participants negative for t(11;14) translocation who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    id
    OG001
    title
    Participants Negative for t(11;14) Translocation
  3. description
    Participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
    id
    OG002
    title
    All Participants
param Type
NUMBER
population Description
Full Analysis Set: participants who received at least 1 dose of study drug (venetoclax 400 mg, pomalidomide 4 mg, and dexamethasone 40 mg)
reporting Status
POSTED
time Frame
Approximately 15 months
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice