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NCT01755975 · OUTCOME

Assess the Overall Response Rate (ORR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
1 year

What was measured

Overall response rate (ORR), complete response rate, very good partial response/partial response rate will be summarized using proportions and confidence intervals will be provided. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

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

Source class 1

complete response rate, very good partial response/partial response rate

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 12Not reportedNot reportedNot reportedNot reported
Dose Level 23Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported
Dose Level 417Not reportedNot reportedNot reportedNot reported

Stable response or progression of disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 11Not reportedNot reportedNot reportedNot reported
Dose Level 24Not reportedNot reportedNot reportedNot reported
Dose Level 33Not reportedNot reportedNot reportedNot reported
Dose Level 419Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        2
      2. group Id
        OG002
        value
        3
      3. group Id
        OG003
        value
        0
      4. group Id
        OG004
        value
        17
      title
      complete response rate, very good partial response/partial response rate
    2. measurements
      1. group Id
        OG001
        value
        1
      2. group Id
        OG002
        value
        4
      3. group Id
        OG003
        value
        3
      4. group Id
        OG004
        value
        19
      title
      Stable response or progression of disease
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
Overall response rate (ORR), complete response rate, very good partial response/partial response rate will be summarized using proportions and confidence intervals will be provided. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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
COUNT_OF_PARTICIPANTS
population Description
No participants treated on Dose Level -1
reporting Status
POSTED
time Frame
1 year
title
Assess the Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice