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NCT00538733 · OUTCOME

Effect of Drug Combination on Multiple Myeloma

Phase II Study of Thalidomide, Clarithromycin, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma · Source last updated 2021-05-24

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
This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles

What was measured

Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/

Analysis population: 25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.

Groups in this outcome

T-BiRD Therapy (All Patients)

26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant). 25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.

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

Analysis denominator · Participants

GroupSource count
T-BiRD Therapy (All Patients)25

Reported measurements

sCR (stringent complete response)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-BiRD Therapy (All Patients)2Not reportedNot reportedNot reportedNot reported
VGPR (very good partial response)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-BiRD Therapy (All Patients)9Not reportedNot reportedNot reportedNot reported
PR (partial response)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-BiRD Therapy (All Patients)9Not reportedNot reportedNot reportedNot reported
SD (stable disease)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
T-BiRD Therapy (All Patients)5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    sCR (stringent complete response)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    VGPR (very good partial response)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    PR (partial response)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    SD (stable disease)
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Objective response rate, defined according to the International Myeloma Working Group (IMWG) criteria as greater then or equal to a Partial Response (PR). The best response was recorded. The IMWG criteria can be found here: imwg.myeloma.org/international-myeloma-working-group-imwg-uniform-response-criteria-for-multiple-myeloma/
groups
  1. description
    26 patients started the treatment phase. Per protocol, completion of the treatment phase was defined as removal from treatment due to progression, or to pursue an alternative treatment (either a stem cell transplant, or further consolidation chemotherapy in pursuit of a transplant). 25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
    id
    OG000
    title
    T-BiRD Therapy (All Patients)
param Type
NUMBER
population Description
25 of the 26 patients enrolled were accessible for response/progression, as one patient expired prior to first response assessment and could not be included in the analysis.
reporting Status
POSTED
time Frame
This was collected from patients for their duration on study treatment. Only the best response was recorded. Best responses were reported at any point of the study, from start of treatment up until removal of study, which occurred up to 57.4 cycles
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