Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS)

Summary

This study is a randomized multicentre, multinational, treatment interventional study of RRMS patients with breakthrough inflammatory disease activity in spite of ongoing standard immunomodulatory medication. The study has two treatment arms; arm A: HSCT (hematopoietic stem cell transplantation) and arm B: alemtuzumab, cladribine or ocrelizumab. A pre-planned 3-year follow-up extension period will be performed depending on future funding.

The aim of the study is to assess the effectiveness and side effects of a new treatment intervention in RRMS; HSCT, and, thereby, the value of HSCT in clinical practice. Data from recently published patient series indicate that HSCT may have a significantly higher treatment effect than currently registered RRMS immunomodulatory treatments. This study will determine the relative role of HSCT versus alemtuzumab, cladribine or ocrelizumab.

Conditions

• Multiple Sclerosis

Interventions

DRUG

Cyclophosphamide and ATG

Hematopoetic stem cell transplantation

DRUG

Alemtuzumab

Alemtuzumab (Lemtrada)

DRUG

Cladribine Pill

Cladribine (Mavenclad)

DRUG

Ocrelizumab

Ocrelizumab (Ocrevus)

Sponsors & Collaborators

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Lars Bø, MD, Phd · Haukeland University Hospital

• Anne Kristine Lehmann, MD, PhD · Haukeland University Hospital

• Astrid Kittang, MD, PhD · Haukeland University Hospital

• Einar Kristoffersen, MD, PhD · Haukeland University Hospital

• Øivind Torkildsen, MD, PhD · Haukeland University Hospital

• Trygve Holmøy, MD, PhD · University Hospital, Akershus

• Margitta Kampman, MD, PhD · Tromsø University Hospital

• Kathrine K Liane, MD · St. Olavs Hospital

• Joachim Burman, MD, PhD · Akademiska sjukhuset, Uppsala

• Morten Blinkenberg, MD, PhD · Rigshospitalet, Denmark

• Jan Lycke, MD, PhD · Sahlgrenska University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-21

Primary Completion

2026-11-21

Completion

2028-03-21

Countries

• Denmark
• Netherlands
• Norway
• Sweden

Study Locations