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NCT02424851 · OUTCOME

Number of Participants With Different Renal Responses to Treatment

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 12 (after receiving 4 cycles of therapy)

Analysis population: Renal response in accordance with IMWG criteria was assessed in 20 patients with eGFR and creatinine clearance data recorded at screening and at the end of four 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)15

Reported measurements

Source class 1

Complete/partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (BBD)5Not reportedNot reportedNot reportedNot reported
Arm B (BTD)1Not reportedNot reportedNot reportedNot reported

Minor response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (BBD)3Not reportedNot reportedNot reportedNot reported
Arm B (BTD)7Not reportedNot reportedNot reportedNot reported

No response

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

Not evaluable

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (BBD)5Not 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 Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.02
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    p Value
    0.02
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
      title
      Complete/partial response
    2. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
      title
      Minor response
    3. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      title
      No response
    4. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
      title
      Not evaluable
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
COUNT_OF_PARTICIPANTS
population Description
Renal response in accordance with IMWG criteria was assessed in 20 patients with eGFR and creatinine clearance data recorded at screening and at the end of four cycles of trial treatment.
reporting Status
POSTED
time Frame
End of week 12 (after receiving 4 cycles of therapy)
title
Number of Participants With Different Renal Responses to Treatment
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice