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NCT00966693 · OUTCOME

Complete Response(CR) and Very Good Partial Response(VGPR)

Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2020-11-04

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).

What was measured

To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir.

Groups in this outcome

RTD (Cohort 1, Phase 1)

Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle

RTD (Cohort 2, Phase 1)

Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle

RTD (Cohort 3, Phase 1)

Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle

RTD (Cohort 2, Phase 2)

Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=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
RTD (Cohort 1, Phase 1)3
RTD (Cohort 2, Phase 1)3
RTD (Cohort 3, Phase 1)9
RTD (Cohort 2, Phase 2)49

Reported measurements

Partial Remission
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)2Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)2Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)13Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)2Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)2Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)6Not reportedNot reportedNot reportedNot reported
Very Good Partial Remission
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)3Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)1Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)8Not reportedNot reportedNot reportedNot reported
Minimal Residual Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)1Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)9Not reportedNot reportedNot reportedNot reported
Stringent Complete Remission
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)3Not reportedNot reportedNot reportedNot reported
Non Evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)1Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)3Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)7Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        13
    title
    Partial Remission
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        6
    title
    Progressive Disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        8
    title
    Very Good Partial Remission
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        9
    title
    Minimal Residual Disease
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        3
    title
    Stringent Complete Remission
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        7
    title
    Non Evaluable
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        7
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      49
    units
    Participants
description
To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir.
groups
  1. description
    Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG000
    title
    RTD (Cohort 1, Phase 1)
  2. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG001
    title
    RTD (Cohort 2, Phase 1)
  3. description
    Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG002
    title
    RTD (Cohort 3, Phase 1)
  4. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG003
    title
    RTD (Cohort 2, Phase 2)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).
title
Complete Response(CR) and Very Good Partial Response(VGPR)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice