MSFrontier

StarMS

A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis.
Completed (inferred)Phase 3Relapsing MS2019-001549-42ISRCTN88667898

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Cyclophosphamide anhydrous
  • Filgrastim

    Granulocyte colony stimulating factor receptor agonist

  • Rabbit anti-human thymocyte immunoglobulin
  • Lenograstim

    Granulocyte colony stimulating factor receptor agonist

Compared with

What it measured

Main measures

  • Proportion of patients who have maintained NEDA status (defined as the absence of all three of the following: protocol defined clinical relapses; 6 months confirmed EDSS progression of at least 1 point with an absence of relapse at the time of assessment; any evidence of MRI disease activity as defined by T1 Gd-enhanced lesion or new and/or enlarging T2 lesion after month 6) in the 2-year post-ran

    Disability progressionRelapsesMRI lesions

Other measures (2)

  • Safety

    Safety

  • Current key secondary outcomes as of 06/05/2026: Safety assessed using: 1. Serious adverse event (SAE) rate within the 2-year follow up period 2. Mortality rate (grade 5 SAEs) within the 2-year follow up period 3. Combined grade 4 and 5 SAE rates within the 2-year follow up period 4. Total number of adverse events (AEs) experienced in the 100 days post-randomisation 5. Total number of AEs within t

    Disability progressionRelapsesMRI lesionsRetina scans (OCT)VisionThinking and memoryFatiguePainMood and sleepQuality of life (reported by participants)Immune responseSafety

Who could take part

Relapsing MS · 16 to 55

Inclusion: 1. Diagnosis of MS using the 2017 McDonald criteria. Exclusion: 1. Diagnosis of primary or secondary progressive MS.

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

About this trial

In the sponsor's words

The main objective of this trial is to assess whether autologous haematopoietic stem cell transplantation (aHSCT) is more effective at maintaining clinical stability in patients with highly active relapsing remitting multiple sclerosis (RRMS) than treatment with a disease modifying therapy (alemtuzumab or ocrelizumab).

Papers

Loading reviews and guidelines…

Related trials

  • NET-MS

    Phase 2 · Stopped early

    Stopped early

  • NA

    Phase 2 · Moved to EU CTIS registry

  • RAM-MS

    Phase 3 · Running, not recruiting

    Still running

  • MOST

    Phase 3 · Stopped early

    Stopped early

  • RAM-MS

    Phase 3 · Moved to EU CTIS registry

  • HiCy

    Phase 2 · Withdrawn

    Stopped early

History

    1. Started

      Feb 2020

    2. Finished

      Sept 2026

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