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NCT02424851 · OUTCOME

Haematological and Non-haematological Toxicity in Both Treatment Arms

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
NUMBER
Unit
Events
Interval / dispersion
Not reported
Time frame
End of weeks 3, 6, 9, 12 (after receiving 4 cycles of therapy), 30 days after final treatment and 12 months after randomisation

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)15

Reported measurements

Serious adverse events
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (BBD)2Not reportedNot reportedNot reportedNot reported
Arm B (BTD)0Not reportedNot reportedNot reportedNot reported
Adverse events
Values in Events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (BBD)3Not reportedNot reportedNot reportedNot reported
Arm B (BTD)6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. group Description
    Statistical analysis of SAEs.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    =0.48
    statistical Method
    Fisher Exact
  2. group Description
    Statistical analysis of AEs
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    =0.25
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Description
    Statistical analysis of SAEs.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    =0.48
    statistical Method
    Fisher Exact
  2. group Description
    Statistical analysis of AEs
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    =0.25
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
    title
    Serious adverse events
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
    title
    Adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      15
    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
NUMBER
reporting Status
POSTED
time Frame
End of weeks 3, 6, 9, 12 (after receiving 4 cycles of therapy), 30 days after final treatment and 12 months after randomisation
title
Haematological and Non-haematological Toxicity in Both Treatment Arms
type
SECONDARY
unit Of Measure
Events

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Preserved source evidence · Not medical advice