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NCT01072773 · OUTCOME

Number of Participants With a Confirmed Hematologic Response

Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis · Source last updated 2014-04-02

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
Duration of treatment (up to 12 cycles/months)

What was measured

Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.

Groups in this outcome

Bortez/Cyc/Dex

Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

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

Analysis denominator · Participants

GroupSource count
Bortez/Cyc/Dex2

Reported measurements

Complete Response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortez/Cyc/Dex0Not reportedNot reportedNot reportedNot reported
Very Good Partial Response (VGPR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortez/Cyc/Dex0Not reportedNot reportedNot reportedNot reported
Partial Response (PR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortez/Cyc/Dex0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Complete Response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Very Good Partial Response (VGPR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial Response (PR)
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    units
    Participants
description
Response that was confirmed on 2 consecutive evaluations during treatment. Complete Response(CR): Complete disappearance of M-protein from serum and urine on immunofixation, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<=100 mg per 24 hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200 mg per 24 hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
groups
  1. description
    Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
    id
    OG000
    title
    Bortez/Cyc/Dex
param Type
NUMBER
reporting Status
POSTED
time Frame
Duration of treatment (up to 12 cycles/months)
title
Number of Participants With a Confirmed Hematologic Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice