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NCT01131169 · OUTCOME

Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS)

Busulfan, Melphalan, Fludarabine and T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation Followed by Post Transplantation Donor Lymphocyte Infusions · Source last updated 2021-12-02

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

Measure
NUMBER
Unit
Proportion of participants PFS
Interval / dispersion
95% Confidence Interval
Time frame
2 years

Analysis population: This objective only applies to Arm I: Participants with Relapsed Multiple Myeloma

Groups in this outcome

Relapsed Multiple Myeloma

This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma

High-risk Multiple Myeloma

This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.

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

Analysis denominator · Participants

GroupSource count
Relapsed Multiple Myeloma47
High-risk Multiple Myeloma0

Reported measurements

Source class 1
Values in Proportion of participants PFS · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Relapsed Multiple Myeloma0.31Not reported0.190.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.19
        upper Limit
        0.5
        value
        0.31
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      0
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma
    id
    OG000
    title
    Relapsed Multiple Myeloma
  2. description
    This is a two arm phase II trial to assess the progression-free and overall survival as well as the safety and efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor in patients with relapsed or high-risk multiple myeloma.
    id
    OG001
    title
    High-risk Multiple Myeloma
param Type
NUMBER
population Description
This objective only applies to Arm I: Participants with Relapsed Multiple Myeloma
reporting Status
POSTED
time Frame
2 years
title
Proportion of Participants With Relapsed Multiple Myeloma With Progression-free (PFS)
type
PRIMARY
unit Of Measure
Proportion of participants PFS

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

Preserved source evidence · Not medical advice