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NCT02509052 · OUTCOME

Clinical Benefit Response Rate (sCR/CR/VGPR/Partial Response [PR]/Minimal Response [MR] or Stable Disease [SD]), Assessed by IMWG Criteria

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the start of treatment until disease progression/recurrence, assessed up to 48 months

What was measured

Clinical benefit response rate (sCR/CR/VGPR/partial response \[PR\]/minimal response \[MR\] or stable disease \[SD\]), assessed by International Myeloma Working Group (IMWG) criteria

Analysis population: Evaluable patients. One patient was non-compliant, therefore, inevaluable. Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.

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 Leflunomide5

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm 1: 20 mg Leflunomide3Not reportedNot reportedNot reportedNot reported
Arm 2: 40 mg Leflunomide3Not reportedNot reportedNot reportedNot reported
Arm 3: 60 mg Leflunomide3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Clinical benefit response rate (sCR/CR/VGPR/partial response \[PR\]/minimal response \[MR\] or stable disease \[SD\]), assessed by International Myeloma Working Group (IMWG) criteria
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
COUNT_OF_PARTICIPANTS
population Description
Evaluable patients. One patient was non-compliant, therefore, inevaluable. Because we obtained preclinical data indicating a synergistic effect between leflunomide and lenalidomide, we determined that investigating leflunomide-based combinational therapy was favorable over pursuing a phase 2 study of single-agent leflunomide. There were no dose de-escalations, so there were no patients accrued to the arms for 10mg, 30mg, or 50mg.
reporting Status
POSTED
time Frame
From the start of treatment until disease progression/recurrence, assessed up to 48 months
title
Clinical Benefit Response Rate (sCR/CR/VGPR/Partial Response [PR]/Minimal Response [MR] or Stable Disease [SD]), Assessed by IMWG Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice