AutoMS-Swe
We could not find results for this trial
I know where the results areWhat it found
We found no results in the registry or in papers.
This trial finished 4 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Autologous hematopoietic stem cell transplantation
What it measured
Main measures
No evidence of disease activity (NEDA)
5 years
RelapsesMRI lesionsTreatment related mortality (TRM)
Up to 18 years
Other measures (9)
No evidence of disease activity (NEDA)
3 years and 10 years
RelapsesMRI lesionsMRI event free survival
At 3, 5 and 10 years
MRI lesionsRelapse free survival
At 3, 5 and 10 years
RelapsesProgression free survival
At 3, 5 and 10 years
Disability progressionAnnualized relapse rate (ARR)
Up to 17 years
RelapsesProportion of patients with clinical improvement
Up to 17 years
Disability progressionEDSS change
At 1, 2 and 3 years
Disability progressionGrade 3 serious adverse events the first 100 days
100 days
SafetyGrade 4 serious adverse events the first 100 days
100 days
Safety
Who could take part
Relapsing MS
Inclusion Criteria: * Diagnosis of multiple sclerosis according to the revised McDonald criteria 2017. * Autologous hematopoietic stem cell transplantation performed for treating multiple sclerosis at a Swedish transplantation center until December 31st 2019. Exclusion Criteria: * Diagnosis of primary progressive MS or secondary progressive MS according to Lublin et al at the time of transplantation. * Patient not accepted reporting of data to the EBMT register. * Not fulfilling requirements of the minimal dataset, se below. Definition of minimal dataset * Data on disease course of multiple sclerosis at the time of transplantation. * Transplantation and the following in-patient care performed in Sweden. * Date of transplantation. * Data on drugs used in conditioning. * At least one follow-up visit performed in Sweden (unless early death before first follow-up visit) including data on: * Clinical assessment * The Kurtzke Expanded Disability Status Scores (EDSS) Additional note: For a patient to be included in the analysis of treatment effectiveness data on MRI evaluation is needed at least once during follow-up.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is an observational cohort study with retrospective analysis of prospectively collected data. The study cohort is constituted of all patients with relapsing-remitting multiple sclerosis (RRMS) treated with autologous stem cell transplantation (AHSCT) in Sweden from 2004 when the first AHSCT was performed until 31 December 2019. The study aims to describe the effectiveness, safety and patient reported outcomes of AHSCT for MS through real world data. Treatment related mortality will be analyzed from start of mobilization until the end of the study. For other adverse events the data collection will end 3 months post-transplantation. A statistical subgroup comparison of efficacy and safety between the conditioning regimens BEAM-ATG and Cy-ATG will be included within the study.
Papers
Background
Compston A, Coles A. Multiple sclerosis. Lancet. 2002 Apr 6;359(9313):1221-31. doi: 10.1016/S0140-6736(02)08220-X.Background
Bronnum-Hansen H, Koch-Henriksen N, Stenager E. Trends in survival and cause of death in Danish patients with multiple sclerosis. Brain. 2004 Apr;127(Pt 4):844-50. doi: 10.1093/brain/awh104. Epub 2004 Feb 11.Background
Daumer M, Griffith LM, Meister W, Nash RA, Wolinsky JS. Survival, and time to an advanced disease state or progression, of untreated patients with moderately severe multiple sclerosis in a multicenter observational database: relevance for design of a clinical trial for high dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation. Mult Scler. 2006 Apr;12(2):174-9. doiBackground
Hader WJ. Disability and survival of multiple sclerosis in Saskatoon, Saskatchewan. Can J Neurol Sci. 2010 Jan;37(1):28-35. doi: 10.1017/s0317167100009616.Background
Skoog B, Runmarker B, Winblad S, Ekholm S, Andersen O. A representative cohort of patients with non-progressive multiple sclerosis at the age of normal life expectancy. Brain. 2012 Mar;135(Pt 3):900-11. doi: 10.1093/brain/awr336.Background
McFarland W, Granville NB, Dameshek W. Autologous bone marrow infusion as an adjunct in therapy of malignant disease. Blood. 1959;14(5):503-521. Blood. 2016 Apr 14;127(15):1839. doi: 10.1182/blood-2016-01-696450.Background
THOMAS ED, LOCHTE HL Jr, CANNON JH, SAHLER OD, FERREBEE JW. Supralethal whole body irradiation and isologous marrow transplantation in man. J Clin Invest. 1959 Oct;38(10 Pt 1-2):1709-16. doi: 10.1172/JCI103949. No abstract available.Background
Reiffers J, Trouette R, Marit G, Montastruc M, Faberes C, Cony-Makhoul P, David B, Bourdeau MJ, Bilhou-Nabera C, Lacombe F, et al. Autologous blood stem cell transplantation for chronic granulocytic leukaemia in transformation: a report of 47 cases. Br J Haematol. 1991 Mar;77(3):339-45. doi: 10.1111/j.1365-2141.1991.tb08581.x.Background
Philip T, Armitage JO, Spitzer G, Chauvin F, Jagannath S, Cahn JY, Colombat P, Goldstone AH, Gorin NC, Flesh M, et al. High-dose therapy and autologous bone marrow transplantation after failure of conventional chemotherapy in adults with intermediate-grade or high-grade non-Hodgkin's lymphoma. N Engl J Med. 1987 Jun 11;316(24):1493-8. doi: 10.1056/NEJM198706113162401.Background
Burt RK, Cohen BA, Russell E, Spero K, Joshi A, Oyama Y, Karpus WJ, Luo K, Jovanovic B, Traynor A, Karlin K, Stefoski D, Burns WH. Hematopoietic stem cell transplantation for progressive multiple sclerosis: failure of a total body irradiation-based conditioning regimen to prevent disease progression in patients with high disability scores. Blood. 2003 Oct 1;102(7):2373-8. doi: 10.1182/blood-2003-0
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History
Started
May 2021
Main results due
Sept 2022
Finished
Sept 2022
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