Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02424851 · OUTCOME

Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain

Optimising Renal Outcome in Myeloma Renal Failure · Source last updated 2022-01-27

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
End of week 6 (after receiving two cycles of therapy)

Analysis population: The primary endpoint of serum free light chain response was assessed in 30 patients where samples were available at screening and the end of two cycles of trial treatment.

Groups in this outcome

Arm A (BBD)

Bortezomib, Bendamustine and Dexamethasone Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised). \*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised) Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle

Arm B (BTD)

Thalidomide, Bendamustine and Dexamethasone Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised) Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised) Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle

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 A (BBD)16
Arm B (BTD)14

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (BBD)13Not reportedNot reportedNot reportedNot reported
Arm B (BTD)3Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.006
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.006
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      14
    units
    Participants
groups
  1. description
    Bortezomib, Bendamustine and Dexamethasone Bortezomib: 1.3 mg/m2 subcutaneously\* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised). \*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised) Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
    id
    OG000
    title
    Arm A (BBD)
  2. description
    Thalidomide, Bendamustine and Dexamethasone Thalidomide: 100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised) Bendamustine: 60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised) Dexamethasone: 40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
    id
    OG001
    title
    Arm B (BTD)
param Type
COUNT_OF_PARTICIPANTS
population Description
The primary endpoint of serum free light chain response was assessed in 30 patients where samples were available at screening and the end of two cycles of trial treatment.
reporting Status
POSTED
time Frame
End of week 6 (after receiving two cycles of therapy)
title
Number of Participants With >50% Reduction From Baseline in Serum Free Light Chain
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice