CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 25 enrolled
Drug / intervention
Granulocyte-colony stimulating factor (G-CSF) and prednisone +2 moredrug
Likely dose
BEAM regimen: Carmustine, etoposide, cytarabine, and melphalan high-dose chemotherapy (specific doses not stated); G-CSF and prednisone growth factor regimen; followed by autologous CD34+ hematopoietic stem cell transplantAI-extracted
Key inclusion· 7
  • ✓Diagnosis of relapsing-remitting or progressive-relapsing multiple sclerosis for less than 15 years using McDonald Criteria
  • ✓EDSS score between 3.0 and 5.5
  • ✓T2 abnormalities on brain MRI consistent with MS
  • ✓Two or more relapses in 18 months despite interferon, glatiramer acetate, natalizumab, or cytotoxic therapy with specified EDSS increase; OR one relapse with EDSS increase of ≥1.5 (or ≥1.0 for EDSS 5.5) sustained ≥4 weeks with MRI changes consistent with poor prognosis
Key exclusion· 15
  • ✕Primary progressive MS
  • ✕Secondary progressive MS without relapses for ≥12 months
  • ✕Neuromyelitis optica or other MS-like disease
  • ✕New immunosuppressant treatment initiated after eligibility or continuation of immunosuppressants after screening (except IFN, GA, or corticosteroids)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00288626
NCT00288626Phase 2Completed
CompareCT.gov

A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Feb 8, 2006·Updated Sep 19, 2017

In Brief

A Phase 2 clinical trial evaluating Granulocyte-colony stimulating factor (G-CSF) and prednisone, Carmustine, etoposide, cytarabine, and melphalan (BEAM), and 1 other intervention for Relapsing-Remitting Multiple Sclerosis. Completed, enrolled 25 participants across 4 sites.

Detailed Summary

The purpose of this study is to determine the effectiveness of a new treatment for multiple sclerosis (MS), a serious disease in which the immune system attacks the brain and spinal cord. MS can be progressive and severe and lead to significant disability. The study treatment involves the use of high-dose chemotherapeutic drugs to suppress the immune system. The participant's own (autologous) blood-forming (hematopoietic, CD34+) stem cells are collected before the chemotherapy is given, and then transplanted back into the body following treatment. Transplantation of autologous hematopoietic stem cells is required to prevent very prolonged periods of low blood cell counts after the high-dose chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing-Remitting Multiple Sclerosis
CountriesUnited States
CollaboratorsImmune Tolerance Network (ITN)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 8, 2006
Enrollment StartJul 1, 2006
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 20.4 years ago

Interventions

Granulocyte-colony stimulating factor (G-CSF) and prednisonedrug

Growth factor regimen; occurs at study entry

Carmustine, etoposide, cytarabine, and melphalan (BEAM)drug

High-dose chemotherapy; occurs seven or more days following collection of autologous graft

Autologous hematopoietic stem cell transplantprocedure

Occurs after growth factor regimen and collection of autologous graft