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NCT02994784 · OUTCOME

Hematologic Overall Response Rate

Propylene Glycol-Free Melphalan Hydrochloride (Evomela) in AL Amyloidosis Patients · Source last updated 2023-05-24

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 months

What was measured

Number of patients with response based on Gertz, Palladini criteria (below) Complete response (CR): Normal serum free light chain ratio,Negative serum and urine immunofixation electrophoresis Very good partial response (VGPR): Difference in serum free light chains less than 40 mg/L Partial Response (PR): \>50% Reduction in the difference in serum free light chains Stable Disease (SD): Meets neither criteria for CR, VGPR, PR or PD

Groups in this outcome

Evomela

Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation Propylene Glycol-Free Melphalan Hydrochloride: Intravenous Propylene Glycol-Free Melphalan Hydrochloride

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

Analysis denominator · Participants

GroupSource count
Evomela27

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Evomela22Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        22
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Number of patients with response based on Gertz, Palladini criteria (below) Complete response (CR): Normal serum free light chain ratio,Negative serum and urine immunofixation electrophoresis Very good partial response (VGPR): Difference in serum free light chains less than 40 mg/L Partial Response (PR): \>50% Reduction in the difference in serum free light chains Stable Disease (SD): Meets neither criteria for CR, VGPR, PR or PD
groups
  1. description
    Propylene Glycol-Free Melphalan Hydrochloride (Evomela) administered intravenously at 70-100 mg/m2/day on Days -3 and -2 prior to autologous stem cell transplantation Propylene Glycol-Free Melphalan Hydrochloride: Intravenous Propylene Glycol-Free Melphalan Hydrochloride
    id
    OG000
    title
    Evomela
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
6 months
title
Hematologic Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice