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NCT02509052 · OUTCOME

Response Duration

Leflunomide in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2023-10-10

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

Measure
MEDIAN
Unit
days
Interval / dispersion
Full Range
Time frame
Assessed up to 48 months

What was measured

Median and range of nine patients with Complete Response (CR)

Analysis population: Among the 12 enrolled patients, only 11 patients are evaluable for response. And 9 of the 11 evaluable patients reached CR. The response duration is based on these 9 CR patients.

Groups in this outcome

Arm 1: 20 mg Leflunomide

Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm 2: 40 mg Leflunomide

Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arm 3: 60 mg Leflunomide

Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Arm 1: 20 mg Leflunomide3
Arm 2: 40 mg Leflunomide3
Arm 3: 60 mg Leflunomide3

Reported measurements

Source class 1
Values in days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm 1: 20 mg Leflunomide336Not reported28401Not reported
Arm 2: 40 mg Leflunomide112Not reported91152Not reported
Arm 3: 60 mg Leflunomide54Not reported2856Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28
        upper Limit
        401
        value
        336
      2. group Id
        OG001
        lower Limit
        91
        upper Limit
        152
        value
        112
      3. group Id
        OG002
        lower Limit
        28
        upper Limit
        56
        value
        54
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    units
    Participants
description
Median and range of nine patients with Complete Response (CR)
dispersion Type
Full Range
groups
  1. description
    Patients receive 20 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm 1: 20 mg Leflunomide
  2. description
    Patients receive 40 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Arm 2: 40 mg Leflunomide
  3. description
    Patients receive 60 mg leflunomide PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    Arm 3: 60 mg Leflunomide
param Type
MEDIAN
population Description
Among the 12 enrolled patients, only 11 patients are evaluable for response. And 9 of the 11 evaluable patients reached CR. The response duration is based on these 9 CR patients.
reporting Status
POSTED
time Frame
Assessed up to 48 months
title
Response Duration
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice