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NCT00564889 · OUTCOME

Number of Patients With Organ Response

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2013-05-14

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 study (up to 3 years)

What was measured

Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid. Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of \>= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by \>= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either \>= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to \< 50% of previous movements/day, or decrease in fecal fat excretion by 50%.

Groups in this outcome

Len/Cyc/Dex

Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m\^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly

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

Analysis denominator · Participants

GroupSource count
Len/Cyc/Dex35

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Len/Cyc/Dex11Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Organ response was evaluated on the basis of improvement of one or more affected organ; only one parameter was required to satisfy the criteria. Response needed to be maintained for a minimum of 3 months to be considered valid. Renal response required a 50% reduction in 24-hour urine protein excretion (at least 0.5 g/d) with stable creatinine. Cardiac response required one of \>= 2-mm reduction in the interventricular septal (IVS) thickness by echocardiogram, or improvement of ejection fraction by \>= 20%, or improvement by 2 NYHA classes without an increase in diuretic use. Hepatic response required either \>= 50% decrease in (or normalization of) an initially elevated alkaline phosphatase level or reduction in the size of the liver by at least 2 cm by radiographic determination. Gastrointestinal tract improvement was defined as normalization of a low serum carotene level, or reduction of diarrhea to \< 50% of previous movements/day, or decrease in fecal fat excretion by 50%.
groups
  1. description
    Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m\^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
    id
    OG000
    title
    Len/Cyc/Dex
param Type
NUMBER
reporting Status
POSTED
time Frame
Duration of study (up to 3 years)
title
Number of Patients With Organ Response
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice