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NCT00833833 · OUTCOME

Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off

MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-04-27

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
Not reported
Time frame
up to 70 weeks

What was measured

IRAC used EBMT criteria to assess myeloma response: * Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors) * Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others * Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others * Stable Disease (SD)- not MR or progressive disease (PD) * Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other * Not Evaluable (NE). Data collection is ongoing and future data results will be included as available.

Analysis population: Intent to treat population. Data collection is ongoing and future data results will be included as available.

Groups in this outcome

Phase 2: Pomalidomide + Dexamethasone

Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.

Phase 2: Pomalidomide

4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Pomalidomide + Dexamethasone113
Phase 2: Pomalidomide108

Reported measurements

Complete response (CR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone0.9Not reportedNot reportedNot reportedNot reported
Phase 2: Pomalidomide0.0Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone29.2Not reportedNot reportedNot reportedNot reported
Phase 2: Pomalidomide9.3Not reportedNot reportedNot reportedNot reported
Minimal response (MR)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone15.0Not reportedNot reportedNot reportedNot reported
Phase 2: Pomalidomide15.7Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone35.4Not reportedNot reportedNot reportedNot reported
Phase 2: Pomalidomide46.3Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone6.2Not reportedNot reportedNot reportedNot reported
Phase 2: Pomalidomide15.7Not reportedNot reportedNot reportedNot reported
Not evaluable
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone13.3Not reportedNot reportedNot reportedNot reported
Phase 2: Pomalidomide13.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.9
      2. group Id
        OG001
        value
        0.0
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        29.2
      2. group Id
        OG001
        value
        9.3
    title
    Partial response (PR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        15.0
      2. group Id
        OG001
        value
        15.7
    title
    Minimal response (MR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        35.4
      2. group Id
        OG001
        value
        46.3
    title
    Stable disease (SD)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        6.2
      2. group Id
        OG001
        value
        15.7
    title
    Progressive disease (PD)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        13.3
      2. group Id
        OG001
        value
        13.0
    title
    Not evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      108
    units
    Participants
description
IRAC used EBMT criteria to assess myeloma response: * Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors) * Partial Response (PR)-not all CR criteria, plus \>=50% reduction in serum monoclonal paraprotein plus others * Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others * Stable Disease (SD)- not MR or progressive disease (PD) * Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other * Not Evaluable (NE). Data collection is ongoing and future data results will be included as available.
groups
  1. description
    Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG000
    title
    Phase 2: Pomalidomide + Dexamethasone
  2. description
    4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
    id
    OG001
    title
    Phase 2: Pomalidomide
param Type
NUMBER
population Description
Intent to treat population. Data collection is ongoing and future data results will be included as available.
reporting Status
POSTED
time Frame
up to 70 weeks
title
Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice