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NCT00558896 · OUTCOME

Duration of Response

CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis · Source last updated 2018-04-18

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Duration of study (up to 5 years)

What was measured

Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.

Analysis population: Participants who achieved a partial response(PR) or better were evaluable for this analysis.

Groups in this outcome

Relapsed Myeloma (<4 Prior Regimens): Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Lenalidomide Refractory Myeloma: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose

Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Relapsed Myeloma (< 4 Prior Regimens): High Dose

Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Relapsed/Refractory Myeloma: High Dose

Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

Relapsed Amyloidosis: Low Dose

Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle

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

Analysis denominator · Participants

GroupSource count
Relapsed Myeloma (<4 Prior Regimens): Low Dose39
Lenalidomide Refractory Myeloma: Low Dose11
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose9
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose10
Relapsed Myeloma (< 4 Prior Regimens): High Dose23
Relapsed/Refractory Myeloma: High Dose25
Relapsed Amyloidosis: Low Dose16

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Relapsed Myeloma (<4 Prior Regimens): Low Dose21.3Not reported11.234.1Not reported
Lenalidomide Refractory Myeloma: Low Dose8.2Not reported3.238.4Not reported
Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose15.6Not reported4.331.1Not reported
Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose3.1Not reported1.814.5Not reported
Relapsed Myeloma (< 4 Prior Regimens): High DoseNANot reportedNANAMedian duration of response was not attained
Relapsed/Refractory Myeloma: High Dose8.3Not reported4.5NAThe upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
Relapsed Amyloidosis: Low Dose19Not reported8.3NAThe upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.2
        upper Limit
        34.1
        value
        21.3
      2. group Id
        OG001
        lower Limit
        3.2
        upper Limit
        38.4
        value
        8.2
      3. group Id
        OG002
        lower Limit
        4.3
        upper Limit
        31.1
        value
        15.6
      4. group Id
        OG003
        lower Limit
        1.8
        upper Limit
        14.5
        value
        3.1
      5. comment
        Median duration of response was not attained
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      6. comment
        The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
        group Id
        OG005
        lower Limit
        4.5
        upper Limit
        NA
        value
        8.3
      7. comment
        The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
        group Id
        OG006
        lower Limit
        8.3
        upper Limit
        NA
        value
        19
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    2. group Id
      OG001
      value
      11
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      23
    6. group Id
      OG005
      value
      25
    7. group Id
      OG006
      value
      16
    units
    Participants
description
Duration of response was calculated from the documentation (date) of first response (CR, VGPR, or PR) until the date of progression or last follow-up in the subset of patients who responded. Kaplan Meier method was used to compute this outcome.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG000
    title
    Relapsed Myeloma (<4 Prior Regimens): Low Dose
  2. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG001
    title
    Lenalidomide Refractory Myeloma: Low Dose
  3. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG002
    title
    Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose
  4. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG003
    title
    Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose
  5. description
    Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG004
    title
    Relapsed Myeloma (< 4 Prior Regimens): High Dose
  6. description
    Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG005
    title
    Relapsed/Refractory Myeloma: High Dose
  7. description
    Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle
    id
    OG006
    title
    Relapsed Amyloidosis: Low Dose
param Type
MEDIAN
population Description
Participants who achieved a partial response(PR) or better were evaluable for this analysis.
reporting Status
POSTED
time Frame
Duration of study (up to 5 years)
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice