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NCT00790842 · OUTCOME

Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]

Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction · Source last updated 2018-10-24

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
56 months

What was measured

Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, \<5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \< 200 mg per 24 hours, \>=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, \>=50% reduction in bone marrow plasma cells, if baseline percentage was \>=30%, \>=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components

Analysis population: Patients treated at the recommended phase II dose

Groups in this outcome

Group A CrCl 30-60 mL/Min

Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

Group B CrCL<30 mL/Min, Not on Dialysis

Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

Group C CrCL<30 mL/Min and on Dialysis

Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.

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

Analysis denominator · Participants

GroupSource count
Group A CrCl 30-60 mL/Min20
Group B CrCL<30 mL/Min, Not on Dialysis10
Group C CrCL<30 mL/Min and on Dialysis5

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Group A CrCl 30-60 mL/Min60.0Not reported39.478.3Not reported
Group B CrCL<30 mL/Min, Not on Dialysis60.0Not reported30.485.0Not reported
Group C CrCL<30 mL/Min and on Dialysis20.0Not reported1.065.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        39.4
        upper Limit
        78.3
        value
        60.0
      2. group Id
        OG001
        lower Limit
        30.4
        upper Limit
        85.0
        value
        60.0
      3. group Id
        OG002
        lower Limit
        1.0
        upper Limit
        65.7
        value
        20.0
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      5
    units
    Participants
description
Per International Myeloma Working Group criteria, complete response (CR): negative immunofixation of serum and urine, normalization of free light chain (FLC) ratio if at study entry FLC was only measurable non-bone parameter, \<5% plasma cells in bone marrow, disappearance of any soft tissue plasma cytomas; stringent complete response (sCR): all of above, + normal serum FLC ratio in all patients and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; partial response (PR): \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \< 200 mg per 24 hours, \>=50% decrease in difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio, \>=50% reduction in bone marrow plasma cells, if baseline percentage was \>=30%, \>=50% reduction in size of soft tissue plasmacytoma; very good partial response (VGPR): PR + improvements in serum and urine M-components
dispersion Type
90% Confidence Interval
groups
  1. description
    Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    OG000
    title
    Group A CrCl 30-60 mL/Min
  2. description
    Lenalidomide at 25 mg/day days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    OG001
    title
    Group B CrCL<30 mL/Min, Not on Dialysis
  3. description
    Lenalidomide at 25 mg/day for days 1-21 and Dexamethasone 40 mg days 1, 8, 15 and 22 every 28 days.
    id
    OG002
    title
    Group C CrCL<30 mL/Min and on Dialysis
param Type
NUMBER
population Description
Patients treated at the recommended phase II dose
reporting Status
POSTED
time Frame
56 months
title
Percentage of Participants Who Experience a Response [sCR, CR, VGPR, PR]
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice