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NCT02112045 · OUTCOME

Number of Participants With Complete Response or Stringent Complete Response

A Study of Granix to Disrupt the Bone Marrow Microenvironment in Patients With Multiple Myeloma Undergoing Autologous Transplantation · Source last updated 2019-11-26

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
Day +100

What was measured

Complete response (CR) requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytomas Stringent complete response (sCR) requires all of the following: * CR as defined above * Normal free light chain ratio * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence

Groups in this outcome

Experimental: Granix and High Dose Melphalan (HDM)

Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0

Control: High Dose Melphalan (HDM)

HDM intravenously (IV) on Day -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
Experimental: Granix and High Dose Melphalan (HDM)44
Control: High Dose Melphalan (HDM)45

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: Granix and High Dose Melphalan (HDM)17Not reportedNot reportedNot reportedNot reported
Control: High Dose Melphalan (HDM)17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        17
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      45
    units
    Participants
description
Complete response (CR) requires all of the following: * Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine * \<5% plasma cells in the bone marrow * Disappearance of soft tissue plasmacytomas Stringent complete response (sCR) requires all of the following: * CR as defined above * Normal free light chain ratio * Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence
groups
  1. description
    Granix on Day -7 through Day -2. HDM intravenously (IV) on Day -2. Autologous stem cell transplantation on Day 0
    id
    OG000
    title
    Experimental: Granix and High Dose Melphalan (HDM)
  2. description
    HDM intravenously (IV) on Day -2.
    id
    OG001
    title
    Control: High Dose Melphalan (HDM)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day +100
title
Number of Participants With Complete Response or Stringent Complete Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice