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NCT00520767 · OUTCOME

Complete Hematologic Response

Bortezomib, Melphalan, and Dexamethasone in Treating Patients With Primary Amyloidosis or Light Chain Deposition Disease · Source last updated 2023-12-22

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
Up to 12 months

Analysis population: Individuals evaluable for response

Groups in this outcome

Melphalan, Dexamethasone, Bortezomib,

Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start 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
Melphalan, Dexamethasone, Bortezomib,33

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melphalan, Dexamethasone, Bortezomib,16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
groups
  1. description
    Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4 bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22 dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23 melphalan: Melphalan 9 mg/m2/day days 1-4 microarray analysis: ≤28 days prior to enrollment flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study. laboratory biomarker analysis: ≤28 days prior to enrollment quality-of-life assessment: Start of each cycle
    id
    OG000
    title
    Melphalan, Dexamethasone, Bortezomib,
param Type
NUMBER
population Description
Individuals evaluable for response
reporting Status
POSTED
time Frame
Up to 12 months
title
Complete Hematologic Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice