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NCT01056276 · OUTCOME

Overall Response Rate

Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy · Source last updated 2017-05-03

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
every 4 weeks for approximately 2 years

What was measured

The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.

Analysis population: All patients evaluable for response.

Groups in this outcome

Originl BBD Regimen

Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4

Modified BBD Regimen

Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15

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

Analysis denominator · Participants

GroupSource count
Originl BBD Regimen17
Modified BBD Regimen39

Reported measurements

CR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Originl BBD Regimen0Not reportedNot reportedNot reportedNot reported
Modified BBD Regimen5Not reportedNot reportedNot reportedNot reported
PR
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Originl BBD Regimen5Not reportedNot reportedNot reportedNot reported
Modified BBD Regimen8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        8
    title
    PR
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      39
    units
    Participants
description
The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.
groups
  1. description
    Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4
    id
    OG000
    title
    Originl BBD Regimen
  2. description
    Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15
    id
    OG001
    title
    Modified BBD Regimen
param Type
NUMBER
population Description
All patients evaluable for response.
reporting Status
POSTED
time Frame
every 4 weeks for approximately 2 years
title
Overall Response Rate
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice