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NCT01755975 · OUTCOME

Assess the Time to Best Response (TTBR)

Romidepsin in Combination With Lenalidomide in Adults With Relapsed or Refractory Lymphomas and Myeloma · Source last updated 2024-11-07

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
up to 50 months

What was measured

Duration of response (DOR), and event free survival (EFS). Time to response,duration of response and event free survival will be analyzed by routine survival analysis tools such as Kaplan-Meier estimation or competing risks method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Analysis population: No participants treated on Dose Level -1

Groups in this outcome

Dose Level -1

Romidepsin 8 mg/m\^2/Lenalidomide 10 mg

Dose Level 1

Romidepsin 8 mg/m\^2/Lenalidomide 15 mg

Dose Level 2

Romidepsin 8 mg/m\^2/Lenalidomide 25 mg

Dose Level 3

Romidepsin 10 mg/m\^2/Lenalidomide 25 mg

Dose Level 4

Romidepsin 14 mg/m\^2/Lenalidomide 25 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
Dose Level -10
Dose Level 13
Dose Level 27
Dose Level 33
Dose Level 436

Reported measurements

Progression Free Survival/PFS
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 15.7Not reported3.716.7Not reported
Dose Level 25.7Not reported3.716.7Not reported
Dose Level 35.7Not reported3.716.7Not reported
Dose Level 45.7Not reported3.716.7Not reported
Overall Survival/OS
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 124.0Not reported10.048.8Not reported
Dose Level 224.0Not reported10.048.8Not reported
Dose Level 324.0Not reported10.048.8Not reported
Dose Level 424.0Not reported10.048.8Not reported
Duration of Response/DOR
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 115.7Not reported4.126.2Not reported
Dose Level 215.7Not reported4.126.2Not reported
Dose Level 315.7Not reported4.126.2Not reported
Dose Level 415.7Not reported4.126.2Not reported
Time To Best Response/TTBR
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 13.7Not reported1.99.0Not reported
Dose Level 23.7Not reported1.99.0Not reported
Dose Level 33.7Not reported1.99.0Not reported
Dose Level 43.7Not reported1.99.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        16.7
        value
        5.7
      2. group Id
        OG002
        lower Limit
        3.7
        upper Limit
        16.7
        value
        5.7
      3. group Id
        OG003
        lower Limit
        3.7
        upper Limit
        16.7
        value
        5.7
      4. group Id
        OG004
        lower Limit
        3.7
        upper Limit
        16.7
        value
        5.7
    title
    Progression Free Survival/PFS
  2. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        10.0
        upper Limit
        48.8
        value
        24.0
      2. group Id
        OG002
        lower Limit
        10.0
        upper Limit
        48.8
        value
        24.0
      3. group Id
        OG003
        lower Limit
        10.0
        upper Limit
        48.8
        value
        24.0
      4. group Id
        OG004
        lower Limit
        10.0
        upper Limit
        48.8
        value
        24.0
    title
    Overall Survival/OS
  3. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        26.2
        value
        15.7
      2. group Id
        OG002
        lower Limit
        4.1
        upper Limit
        26.2
        value
        15.7
      3. group Id
        OG003
        lower Limit
        4.1
        upper Limit
        26.2
        value
        15.7
      4. group Id
        OG004
        lower Limit
        4.1
        upper Limit
        26.2
        value
        15.7
    title
    Duration of Response/DOR
  4. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        1.9
        upper Limit
        9.0
        value
        3.7
      2. group Id
        OG002
        lower Limit
        1.9
        upper Limit
        9.0
        value
        3.7
      3. group Id
        OG003
        lower Limit
        1.9
        upper Limit
        9.0
        value
        3.7
      4. group Id
        OG004
        lower Limit
        1.9
        upper Limit
        9.0
        value
        3.7
    title
    Time To Best Response/TTBR
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      7
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      36
    units
    Participants
description
Duration of response (DOR), and event free survival (EFS). Time to response,duration of response and event free survival will be analyzed by routine survival analysis tools such as Kaplan-Meier estimation or competing risks method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
dispersion Type
95% Confidence Interval
groups
  1. description
    Romidepsin 8 mg/m\^2/Lenalidomide 10 mg
    id
    OG000
    title
    Dose Level -1
  2. description
    Romidepsin 8 mg/m\^2/Lenalidomide 15 mg
    id
    OG001
    title
    Dose Level 1
  3. description
    Romidepsin 8 mg/m\^2/Lenalidomide 25 mg
    id
    OG002
    title
    Dose Level 2
  4. description
    Romidepsin 10 mg/m\^2/Lenalidomide 25 mg
    id
    OG003
    title
    Dose Level 3
  5. description
    Romidepsin 14 mg/m\^2/Lenalidomide 25 mg
    id
    OG004
    title
    Dose Level 4
param Type
MEDIAN
population Description
No participants treated on Dose Level -1
reporting Status
POSTED
time Frame
up to 50 months
title
Assess the Time to Best Response (TTBR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice