Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.

• Conditions: Relapsing-remitting multiple sclerosis; MedDRA version: 13.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2010-023560-40-SE
• Lead Sponsor: ppsala l?ns landsting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-21
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age between 18 -55, inclusive.
2. Diagnosis of MS using McDonald criteria of clinically definite MS.
3. An EDSS of 2.0 to 6.0.
4. Inflammatory disease despite treatment with standard disease modifying therapy including at least 6 months of interferon or copaxone.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.
2. More than six cycles prior therapy with mitoxantrone.
3. Prior history of malignancy except localized basal cell, squameous skin cancer or carcinoma in situ of the cervix. Other malignancies for whoich the patient is judged to be cured, such as haed and neck cancer, or breast cancer wil lbe considered on an individual basis.
4. Positive pregnancy test.
5. Inability or unwillingness to pursue effective means of birth control....

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of autologous HSCT versus the FDA approved<br>standard of care, natalizumab, for inflammatory MS failing alternate<br>approved therapy.<br>(The original protocol from Northwestern University, Chicago, includes<br>interferon, glatiramer acetate and mitoxantrone as comparators as well; we<br>will only use natalizumab.)<br>;Secondary Objective: ;Primary end point(s): Disease progression, defined as a 1-point increase in the EDSS on consecutive evaluations at least 6 months apart and not due to a non-MS disease process. Patients will be followed for 5 years after randomization.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Number of relapses<br>Ambulation index<br>25 foot timed walk<br>9 hole PEG test<br>PASAT-3 second and PASAT-2 second<br>MRI enhancing lesions and T1 and T2 burden of disease per CombiRx MRI protocol<br>SF-36 and MSQOL<br>Scripps NRS<br>Survival