High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study

Inclusion Criteria:

Diagnosis of relapsing-remitting or progressive-relapsing multiple sclerosis for less than 15 years using McDonald Criteria. More information on this criterion can be found in the protocol
Score between 3.0 and 5.5 on the Expanded Disability Status Scale (EDSS)
T2 abnormalities on brain MRI consistent with MS
Two or more relapses in 18 months time on interferon (IFN), glatiramer acetate (GA), natalizumab or cytotoxic therapy with EDSS increase of 1.0 or greater for participants with EDSS at screening of 3.0 to 3.5 (0.5 or greater for participants with EDSS at screening of 4.0 to 5.5) sustained at least 4 weeks after at least one of these relapses OR one relapse on IFN, GA, natalizumab or cytotoxic therapy with EDSS increase of 1.5 or greater (1.0 for subjects with EDSS at screening of 5.5) sustained at least 4 weeks, together with MRI changes consistent with poor prognosis. More information on this criterion can be found in the protocol.
On IFN or GA for at least 6 months before the relapses occur that are counted to satisfy previous inclusion criterion OR have received adequate doses of natalizumab or cytotoxic therapy on a treatment schedule before the relapses occur that are counted to satisfy previous inclusion criterion
Approval by an MS Review Panel to participate in the study. More information on this criterion can be found in the protocol
In good clinical condition with adequate organ function and without coexisting medical problems that would increase the risk to the participant
Willing to use acceptable methods of contraception
Willing and able to comply with all study requirements and
Willing to accept and comprehend irreversible sterility as side effect of therapy.

Exclusion Criteria:

Primary progressive MS
Secondary progressive MS without relapses (i.e., progression without exacerbations or relapses) for 12 or more months
Neuromyelitis optica, a disease similar to MS
Initiation of new immunosuppressant treatment after the participant becomes eligible for the protocol or continuance of immunosuppressant drugs after the participant is screened for the protocol. Treatment with IFN, GA, or corticosteroids is permitted after the participant becomes eligible for the protocol.
Lapse of greater than 6 months between the time a participant is eligible for the protocol and initiation of protocol treatment except when judged acceptable by the MS Review Panel
Prior treatment with investigational immunosuppressive agents within 3 months of study eligibility
Positive baseline plasma and CSF testing for JC virus or a brain MRI that has changes consistent with a diagnosis of progressive multifocal encephalopathy (PML)
History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS)
Active hepatitis B or C infection, cirrhosis, or HIV infection
Uncontrolled diabetes mellitus
Uncontrolled viral, fungal, or bacterial infection. Patients with asymptomatic bacteriuria are not excluded
Any illness that would jeopardize the ability to tolerate aggressive chemotherapy
Prior history of malignancy, except localized basal cell or squamous skin cancer. Other malignancies for which the subject is judged cured by the administered therapy will be considered on an individual basis.
Hypersensitivity to mouse, rabbit, or Escherichia coli-derived proteins or to iron compounds/medications
Metallic objects implanted in the body that would affect MRI exams
Psychiatric illness, mental deficiency, or cognitive dysfunction or
Pregnancy.