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NCT00538733 · OUTCOME

Progression Free Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From start of treatment, to the date of first progression

What was measured

Progression determined using International Myeloma Working Group criteria, as defined below. An increase of \> 25% from lowest response value one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)\* * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder \*if starting serum M protein is greater then 5 g/dL, absolute increase of 1g/dL is sufficient to determine relapse.

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)

25 of the 26 patients enrolled onto the were assessed for 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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
T-BiRD Therapy (All Patients)35.6Not reported14.1NAn/a has been entered because this was not reached
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        n/a has been entered because this was not reached
        group Id
        OG000
        lower Limit
        14.1
        upper Limit
        NA
        value
        35.6
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
Progression determined using International Myeloma Working Group criteria, as defined below. An increase of \> 25% from lowest response value one or more of the following: * Serum M-component and/or (the absolute increase must be \> 0.5 g/dL)\* * Urine M-component and/or (the absolute increase must be \> 200 mg/24 h) * Only in patients without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \> 10 mg/dL * Bone marrow plasma cell percentage; the absolute percentage must be \> 10% * Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas * Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder \*if starting serum M protein is greater then 5 g/dL, absolute increase of 1g/dL is sufficient to determine relapse.
dispersion Type
95% Confidence Interval
groups
  1. description
    25 of the 26 patients enrolled onto the were assessed for 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
MEDIAN
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
From start of treatment, to the date of first progression
title
Progression Free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice