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NCT00538824 · OUTCOME

Effect of Drug Combination on Multiple Myeloma

Phase II Study of Dexamethasone, Thalidomide and Lenalidomide for Subjects With Relapsed or Refractory Multiple Myeloma · Source last updated 2018-06-06

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks

What was measured

The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/

Groups in this outcome

DexTR (All Patients)

All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt

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

Analysis denominator · Participants

GroupSource count
DexTR (All Patients)5

Reported measurements

partial response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DexTR (All Patients)2Not reportedNot reportedNot reportedNot reported
minimal response (MR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DexTR (All Patients)1Not reportedNot reportedNot reportedNot reported
progression of disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
DexTR (All Patients)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    partial response (PR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    minimal response (MR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    progression of disease
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
The maximum response for all patients that were treated on study. Maximum response was assessed using the International myeloma working group (IMWG) guidelines for response. http://imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
groups
  1. description
    All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a total of 4 cycles of 28 days each. dexamethasone: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation or achieve a plateau of disease (no change in M-spike as detected on serum protein electrophoresis) for \> 2 cycles will be transitioned to maintenance therapy. * Patients who continue to respond without achieving either a plateau or a CR will continue on induction therapy until plateau for \>2 cycles or CR in the absence of unt
    id
    OG000
    title
    DexTR (All Patients)
param Type
NUMBER
reporting Status
POSTED
time Frame
The best response for all patients at any point were assessed for patients that were treated on study, from start of treatment up to 20 weeks
title
Effect of Drug Combination on Multiple Myeloma
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice