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NCT01413178 · OUTCOME

Number of Participants With Complete Response (CR)

A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma · Source last updated 2020-04-21

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
Evaluated 90 days from transplant.

What was measured

Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria.

Groups in this outcome

Busulfan + Melphalan

Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant

Melphalan

High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant

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

Analysis denominator · Participants

GroupSource count
Busulfan + Melphalan104
Melphalan98

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Busulfan + Melphalan12Not reportedNot reportedNot reportedNot reported
Melphalan15Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        15
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      98
    units
    Participants
description
Complete response (CR), evaluated 90 days from transplant, defined as (i) negative immunofixation of the multiple myeloma (MM) protein in urine and serum, (ii) disappearance of any soft tissue plasmacytomas, and (iii) less than 5% plasma MM cells in the bone marrow. International Myeloma Working Group uniform response criteria.
groups
  1. description
    Busulfan with a target daily area under the curve (AUC) of 5000 with Melphalan 70 mg/m2 followed by a stem cell transplant
    id
    OG000
    title
    Busulfan + Melphalan
  2. description
    High-dose Melphalan 200 mg/m2/day followed by a stem cell transplant
    id
    OG001
    title
    Melphalan
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Evaluated 90 days from transplant.
title
Number of Participants With Complete Response (CR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice