The StarMS study gains it's acronym from the trial name: Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis, which "aims to compare the efficacy and safety profile of Autologous Haematopoietic Stem Cell Transplantation (aHSCT) vs 'highly effective' Disease Modifying Therapies (DMTs) – Ocrelizumab, Alemtuzumab, Cladribine and Ofatumumab." The study will recruit 198 MS patients, and randomly sorted into groups that will receive either Autologous Haematopoietic Stem Cell Transplantation (aHSCT) or Disease Modifying Therapies (DMTs), then observe the effects over a 24 month period.
Participants allocated to the aHSCT arm will have stem cells removed (harvested) from the blood. Participants will then undergo 'conditioning' where the patients receive chemotherapy before their stem cells are transplanted (re-infused) into the participants' blood. The re-infused stem cells give rise to a new generation of immune cells, replacing the original 'sick' immune system.
DMTStarMS | University of Sheffield
Participants allocated to the DMT arm will receive either Alemtuzumab, Ocrelizumab, Caldribine, or Ofatumumab administered and monitored as per licence. This decision will be based on the participant's suitability for each drug based on current guidelines as well as clinician/participant preference.