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NCT00679367 · OUTCOME

Number of Organs Improved or Stable Based on Description Below:

Melphalan, Lenalidomide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2017-02-20

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

Measure
NUMBER
Unit
number of organs stable or improved
Interval / dispersion
Not reported
Time frame
one year

What was measured

Renal response - \> 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency. Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline. Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness \> 11 mm or a decrease in New York Heart Association heart failure class. Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus. Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid. Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy.

Groups in this outcome

Melphalan Revlimid and Dexamethasone

Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 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
Melphalan Revlimid and Dexamethasone14

Analysis denominator · involved organs

GroupSource count
Melphalan Revlimid and Dexamethasone24

Reported measurements

Source class 1
Values in number of organs stable or improved · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melphalan Revlimid and Dexamethasone10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
denom Units Selected
involved organs
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
  2. counts
    1. group Id
      OG000
      value
      24
    units
    involved organs
description
Renal response - \> 50% decrease in daily 24 hour proteinuria, without worsening renal insufficiency. Hepatic response - decrease of 2 centimeters or more of the liver span and/or decrease of the alkaline phosphatase by 50% if elevated at baseline. Cardiac response - decrease of 2 millimeters or more in mean left ventricular wall thickness in patients with baseline wall thickness \> 11 mm or a decrease in New York Heart Association heart failure class. Autonomic nervous system response - resolution of orthostatic vital signs and symptoms, and resolution of symptoms of gastric atony or of functional ileus. Gastrointestinal response - a greater than one grade improvement in diarrhea due to biopsy proven amyloid. Peripheral nervous system response - resolution of clinical signs of peripheral neuropathy.
groups
  1. description
    Melphalan Lenalidomide Dexamethasone dexamethasone: 40 mg once weekly lenalidomide: 10 mg/day Days 1-21 melphalan: 5 mg/m2 Days 1-4
    id
    OG000
    title
    Melphalan Revlimid and Dexamethasone
param Type
NUMBER
reporting Status
POSTED
time Frame
one year
title
Number of Organs Improved or Stable Based on Description Below:
type
SECONDARY
type Units Analyzed
involved organs
unit Of Measure
number of organs stable or improved

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

Preserved source evidence · Not medical advice