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NCT00458822 · OUTCOME

Hematologic and Organ Response

Melphalan and Autologous Stem Cell Transplant Followed By Bortezomib and Dexamethasone in Treating Patients With Previously Untreated Systemic Amyloidosis · Source last updated 2016-08-10

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
2-3 months post transplant

What was measured

patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.

Groups in this outcome

All Patients

All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis

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

Analysis denominator · Participants

GroupSource count
All Patients40

Reported measurements

Complete Hematologic Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients11Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients7Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients18Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Complete Hematologic Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Stable Disease
denoms
  1. counts
    1. group Id
      OG000
      value
      40
    units
    Participants
description
patients will be assessed for hematologic response (the response of the clonal plasma cell disease). If the plasma cell disease persists, then they will receive 6 cycles of adjuvant therapy with bortezomib and dexamethasone; patients with peripheral neuropathy will receive dexamethasone alone because of the risk of neuropathy associated with bortezomib. Symptomatic organ involvement with amyloid as defined below. Patients must have symptomatic involvement of no more than 2 of the following 4 visceral organ-systems: kidneys, liver/GI, peripheral/autonomic nervous system, and heart.
groups
  1. description
    All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
    id
    OG000
    title
    All Patients
param Type
NUMBER
reporting Status
POSTED
time Frame
2-3 months post transplant
title
Hematologic and Organ Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice