Investigating the effects of therapies on multiple sclerosis progression after bone marrow transplantation
Biomarkers of Disease PROgression and Myeloid Profiling in Patients With Relapsing Remitting Multiple Sclerosis Treated With Autologous Hematopoietic Stem Cell TRANSPLANTation and Second Line Therapies.
This study is testing whether certain therapies can help people with relapsing-remitting multiple sclerosis avoid worsening their condition after undergoing a specific type of stem cell transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Academic / other |
| Drugs / interventions | alemtuzumab, ocrelizumab, ofatumumab |
| Locations | 1 site (Milan) |
| Trial ID | NCT06267781 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore how highly effective therapies can prevent disease progression in individuals with relapsing-remitting multiple sclerosis (RRMS) by analyzing the peripheral myeloid landscape. It focuses on the impact of disease-modifying therapies (DMTs) on preventing the transition to secondary progressive multiple sclerosis (SPMS) and understanding the underlying mechanisms of disease progression. The study will evaluate the effects of myeloablative autologous hematopoietic stem cell transplantation (aHSCT) compared to other DMTs like ocrelizumab and alemtuzumab, particularly in modulating immune responses. The findings could significantly influence clinical decisions regarding long-term treatment strategies for MS patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of RRMS and high inflammatory disease activity.
Not a fit: Patients with primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS) will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that halt the progression of multiple sclerosis, enhancing patients' quality of life.
How similar studies have performed: While the approach of using aHSCT in MS is established, the specific focus on myeloid profiling and its effects on disease progression is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years; * Signed written informed consent; * A diagnosis of RRMS according to the 2017 Revisions of the McDonald Criteria; * High clinical and magnetic resonance imaging (MRI) inflammatory disease activity (at least 2 clinical relapses, or one clinical relapse with gadolinium (Gd)- enhancing or new T2 MRI lesions at a separate time point, in the previous 12 months) * Patients referred for pharmacological treatment with aHSCT, alemtuzumab or ocrelizumab /ofatumumab, according to clinical practice following the Italian pharmacological regulatory agency (AIFA) criteria and guidelines and recommendations from the European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of EBMT and ISCT (JACIE); Exclusion Criteria: * Diagnosis of PPMS or SPMS according to the 2017 McDonald criteria * Known intolerances/allergies to the active substance or the excipients contained in the DMT and/or contraindications according to product information
Where this trial is running
Milan
- IRCCS San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Massimo Filippi — IRCCS San Raffaele
- Study coordinator: Angela Genchi
- Email: genchi.angela@hst.it
- Phone: +390226452846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.