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NCT00635024 · OUTCOME

Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response

Anti-thymocyte Globulin and Melphalan in Treating Patients With Relapsed Multiple Myeloma · Source last updated 2017-02-10

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
4 months

What was measured

Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.

Analysis population: One participant was evaluable for the primary endpoint.

Groups in this outcome

Anti-thymocyte Globulin/Melphalan

Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)

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

Analysis denominator · Participants

GroupSource count
Anti-thymocyte Globulin/Melphalan1

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Anti-thymocyte Globulin/Melphalan0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    units
    Participants
description
Response that was confirmed on 2 consecutive evaluations during the first 4 months of treatment. Complete Response(CR): Disappearance of M-protein from serum and urine, normalization of Free Light Chain (FLC) ratio and \<5% plasma cells in bone marrow. Very Good Partial Response(VGPR): \>=90% reduction in serum M-component; Urine M-Component \<100mg per 24hours. Partial Response(PR): \>=50% reduction in serum M-component and/or Urine M-Component \>=90% reduction or \<200mg per 24hours; or \>=50% decrease in difference between involved and uninvolved FLC levels.
groups
  1. description
    Anti-thymocyte Globulin (2.5 mg/Kg)and Melphalan (16 mg/m\^2)
    id
    OG000
    title
    Anti-thymocyte Globulin/Melphalan
param Type
NUMBER
population Description
One participant was evaluable for the primary endpoint.
reporting Status
POSTED
time Frame
4 months
title
Hematological Response Rate Defined as the Number of Participants Who Achieve a Confirmed Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice