FAQs

Patients aged 16-55 who have highly active RRMS with 1 or more protocol defined relapses or evidence of MRI disease activity in last 12 months despite being on a DMT, or rapidly evolving severe MS in treatment naïve patients may be eligible to take part. However, eligibility depends on many factors. Potentially eligible participants will undergo a number of screening assessments, and each case will be reviewed by a central team of neurologists involved in the study. This is to ensure that patients only take part if the trial, and receive the trial treatment(s), if it is right for them and their condition. Patients who feel they may be eligible, and would like to take part in the trial, should contact their treating neurologist. Please review the eligibility questionnaire for more details on eligibility and to see if you may be eligible.

No, patients cannot be included if they are taking part in another interventional clinical trial.

No, you don’t need to have registered with the UK MS register to take part in StarMS. However, we do strongly suggest you sign up.

If you are interested in taking part in the trial, the first step is to discuss it with your treating neurologist. If they believe, from a clinical perspective, that you may be suitable for the trial, they can refer you to one of the StarMS participating centres.

Once you have been referred, you will have the opportunity to discuss the trial in detail with the local research team including representatives from the neurology and haematology teams. You will also have the opportunity to visit your local transplant centre and receive counselling from an independent clinician before you decide whether to take part.

No. Patients who are pregnant, breastfeeding, or planning to become pregnant during the study will not be able to take part. This is because it is possible that the treatments given could harm an unborn child.

You will have the opportunity to visit your local transplant centre and receive counselling from an independent clinician before you decide whether to take part.

Should you be interested in participating, we will need to make sure that the study is right for you. You will be asked to provide your consent to take part in the trial and undergo some initial assessments.

If you are suitable for the trial, you will be randomly allocated to receive aHSCT or DMT and will remain in the study for follow up for two years. Visits to hospital will be required at 3, 6, 9, 12, 18 and 24 months after joining the study.

All aspects of the stem cell transplant procedure will take place at your local participating treatment centre, which is accredited to carry out the treatment. Please see a treatment summary below:

Mobilisation

This is the first stage of the treatment. You may need to be admitted to hospital for this stage of the treatment or you may be able to receive it as an outpatient, attending hospital on the relevant days.

You will have an infusion of a strong immune suppressing chemotherapy drug called cyclophosphamide (2g/m²), followed by daily injections of a specific growth factor (filgrastim or lenograstim) starting 5 days after the cyclophosphamide. As a result, stem cells will move from the bone marrow to the blood. Enough cells can usually be counted in blood samples after 5 days of filgrastim. Because mobilisation uses a powerful immunosuppressive drug, you may already experience an improvement to your MS symptoms.

Leukapheresis

Once there are enough stem cells in the bloodstream, they will be harvested, using a process called leukapheresis. This procedure requires access to large veins.

One line is used to transport your blood via a tube to the centrifuge, the machine that separates the stem cells from the blood itself; and another line is used to deliver the remainder of the blood back to you. This may be by inserting a cannula and/or central venous line (tube) into the arm, into the side of the neck or below the collar bone. There are some risks associated with inserting this line, although these are often minor and you will be monitored closely during treatment for the presence of these. Risks include infection, bleeding and clot formation. The whole procedure takes about 3 – 5 hours. The amount of blood in the infusion system is always less than ½ litre of blood. The collected cells will be cryopreserved (frozen) until later use at transplantation (see below).

A small number of patients experience a failure of blood stem cells collection. In this case your doctor may decide either to repeat the procedure or to withdraw you from the trial.

After leukapheresis, it will usually be around 2 – 5 weeks before you receive the next part of the treatment.

Immunoablation (chemotherapy) and stem cell transplantation

The chemotherapy process involves infusions of low dose cyclophosphamide given on each of 4 days, with antithymocyte globulin (‘ATG’). This is followed by re-infusion of your own harvested blood stem cells (‘autologous haematopoietic stem cell transplantation’) on the day after the last infusion of ATG. ATG is a protein derived from rabbits that is commonly used to effectively reduce all immune cells in recipients of stem cell transplantation. You may need to be in hospital for several weeks to carry out these steps, and to cover any unwanted consequences that may occur as a result of the therapy. Antibiotic treatment and transfusions of red blood cells or platelets are usually necessary in the period immediately following the transplantation.

For this phase of the process, you will need to be admitted into an isolation bay, to minimise the risk of infection due to your depleted immune system. This will mean you having an individual hospital room, but you will still be allowed to have visitors during this time.

Following completion of the transplantation, in line with standard clinical care requirements for transplants, you will be required to attend hospital on a weekly basis for the first few weeks to check for any evidence of infection. The haematologist at your hospital will be able to discuss this with you, and answer any questions you may have. You will also have additional blood tests taken, dependent on clinical need, to check for any adverse effects of the transplant treatment. These are in addition to the blood tests that are part of the follow up visits (see figure 3). You will also be required to take preventative treatments to avoid infections for up to 12 months. This includes antifungals and antivirals.

Vaccination

As part of routine care for stem cell transplants you will undergo a programme of re-vaccination in the months following the transplant. This will be organised with your General Practitioner (GP). Your Haematologist will also advise you whether any other members of your household also require any vaccinations.

Patients who are allocated to receive a highly effective disease modifying therapy will be treated with alemtuzumab or ocrelizumab. Your doctor will confirm which of these treatments are suitable for you. Please see DMT treatment summaries below:

If you are allocated Alemtuzumab, you will receive an IV infusion over 2 treatment courses.

For the initial course, you will receive an infusion on 5 consecutive days. 12 months later, you will receive course two as an infusion on three consecutive days. You may receive this treatment as an inpatient or outpatient, depending on your hospital.

If you are allocated Ocrelizumab, you will receive two IV infusions 2 weeks apart. These infusions will each take approximately 2.5 hours. Future treatments will be given as one infusion every 6 months, and will take approximately ⅗ hours each.

If you are allocated Cladribine you will receive the drug in tablet form over two treatment courses.

Dosage is given over two treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective treatment year. Each treatment week comprises 4 or 5 days in which you receive a tablet as a single daily dose depending on body weight.

If you are allocated Ofatumumab you will receive the drug via injection (under the skin) with an initial dose at weeks 0, 1 and 2 followed by subsequent monthly doses starting at week 4.

The study treatments affect your immune system and this may make you more vulnerable to COVID-19 or its complications. You will only receive treatment in the study if this is deemed safe according to current national and local guidelines. If you are allocated to receive a stem cell transplant, you may be required to “shield” for a period of time following the transplant. This will involve limiting your social contact. The national and local guidance on COVID-19 is reviewed regularly and the study will follow these guidelines at all times.

Click here for a full list of participating centres.

Click here to access the StarMS Participant Information Sheet which contains more information about the trial. If you have any further questions, please contact your treating neurologist.

Please contact your treating neurologist to discuss potential participation in the StarMS trial.

Half of the people who take part in StarMS will receive aHSCT, and half will receive a DMT. Which treatment a person gets will be decided by chance (like tossing a coin). This is called randomisation. This makes sure that the patients in each treatment group are as similar as possible, except for the treatment they receive. Neither you nor your doctor will have any influence over which treatment you receive.

If you are randomly allocated to receive a DMT, you will receive treatment with either Alemtuzumab, Ocrelizumab, Cladribine, or Ofatumumab. The decision on which DMT you receive will depend on your condition and suitability and yours and your doctor’s preference.