CompletedRelapsing MSNCT05029206

We could not find results for this trial

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What it found

No result found

We found no results in the registry or in papers.

This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Autologous hematopoietic stem cell transplantation

What it measured

Main measures

  • No evidence of disease activity (NEDA)

    5 years

    RelapsesMRI lesions
  • Treatment related mortality (TRM)

    Up to 18 years

Other measures (9)

  • No evidence of disease activity (NEDA)

    3 years and 10 years

    RelapsesMRI lesions
  • MRI event free survival

    At 3, 5 and 10 years

    MRI lesions
  • Relapse free survival

    At 3, 5 and 10 years

    Relapses
  • Progression free survival

    At 3, 5 and 10 years

    Disability progression
  • Annualized relapse rate (ARR)

    Up to 17 years

    Relapses
  • Proportion of patients with clinical improvement

    Up to 17 years

    Disability progression
  • EDSS change

    At 1, 2 and 3 years

    Disability progression
  • Grade 3 serious adverse events the first 100 days

    100 days

    Safety
  • Grade 4 serious adverse events the first 100 days

    100 days

    Safety

Who could take part

Relapsing MS

Inclusion Criteria: * Diagnosis of multiple sclerosis according to the revised McDonald criteria 2017. * Autologous hematopoietic stem cell transplantation performed for treating multiple sclerosis at a Swedish transplantation center until December 31st 2019. Exclusion Criteria: * Diagnosis of primary progressive MS or secondary progressive MS according to Lublin et al at the time of transplantation. * Patient not accepted reporting of data to the EBMT register. * Not fulfilling requirements of the minimal dataset, se below. Definition of minimal dataset * Data on disease course of multiple sclerosis at the time of transplantation. * Transplantation and the following in-patient care performed in Sweden. * Date of transplantation. * Data on drugs used in conditioning. * At least one follow-up visit performed in Sweden (unless early death before first follow-up visit) including data on: * Clinical assessment * The Kurtzke Expanded Disability Status Scores (EDSS) Additional note: For a patient to be included in the analysis of treatment effectiveness data on MRI evaluation is needed at least once during follow-up.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is an observational cohort study with retrospective analysis of prospectively collected data. The study cohort is constituted of all patients with relapsing-remitting multiple sclerosis (RRMS) treated with autologous stem cell transplantation (AHSCT) in Sweden from 2004 when the first AHSCT was performed until 31 December 2019. The study aims to describe the effectiveness, safety and patient reported outcomes of AHSCT for MS through real world data. Treatment related mortality will be analyzed from start of mobilization until the end of the study. For other adverse events the data collection will end 3 months post-transplantation. A statistical subgroup comparison of efficacy and safety between the conditioning regimens BEAM-ATG and Cy-ATG will be included within the study.

Papers

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History

    1. Started

      May 2021

    2. Main results due

      Sept 2022

    3. Finished

      Sept 2022

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