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NCT00124579 · OUTCOME

Toxicity Evaluation

S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2018-08-09

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

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years

What was measured

To evaluate the qualitative and quantitative toxicities associated with this regimen.

Analysis population: All participants receiving at least one dose of induction therapy

Groups in this outcome

Bortezomib + Thal/Dex

Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.

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

Analysis denominator · Participants

GroupSource count
Bortezomib + Thal/Dex7

Reported measurements

Albumin, serum-low (hypoalbuminemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Allergy/Immunology-Other
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Bilirubin (hyperbilirubinemia)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Edema: limb
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Extremity-lower (gait/walking)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Fatigue (asthenia, lethargy, malaise)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Hemoglobin
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Inf (clin/microbio) w/Gr 3-4 neuts - Lung
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Leukocytes (total WBC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Lymphopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Muscle weakness, not d/t neuropathy - Extrem-lower
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Muscle weakness, not d/t neuropathy - body/general
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Neuropathy: motor
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Neuropathy: sensory
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Neutrophils/granulocytes (ANC/AGC)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex2Not reportedNot reportedNot reportedNot reported
Platelets
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib + Thal/Dex1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Albumin, serum-low (hypoalbuminemia)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Allergy/Immunology-Other
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Bilirubin (hyperbilirubinemia)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Edema: limb
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Extremity-lower (gait/walking)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatigue (asthenia, lethargy, malaise)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hemoglobin
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Inf (clin/microbio) w/Gr 3-4 neuts - Lung
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Leukocytes (total WBC)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Lymphopenia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Muscle weakness, not d/t neuropathy - Extrem-lower
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Muscle weakness, not d/t neuropathy - body/general
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
To evaluate the qualitative and quantitative toxicities associated with this regimen.
groups
  1. description
    Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21). Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4.
    id
    OG000
    title
    Bortezomib + Thal/Dex
param Type
NUMBER
population Description
All participants receiving at least one dose of induction therapy
reporting Status
POSTED
time Frame
From date of protocol therapy start to date of protocol therapy end, i.e., up to about 3.5 years
title
Toxicity Evaluation
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice