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  1. AU="Debbie Sherratt"
  2. AU="Zhen, Jimmy"
  3. AU=Haraj Nassim Essabah
  4. AU="Garabiles, Melissa R."
  5. AU="Jin-cai Hou"
  6. AU="Kolb, Jennifer M"
  7. AU=Kalra Paul R
  8. AU="Miller, Mona"
  9. AU="Tao Ming Sim"
  10. AU="Simen, Susanne"
  11. AU="Jole Costanza"
  12. AU="Paula, Camila S Y"
  13. AU="Azevedo, Helena S"
  14. AU=Molyneaux Phillip L.
  15. AU=Shimizu Kazuki
  16. AU=Pell Robert AU=Pell Robert
  17. AU="Aguiar, Liza"
  18. AU="Bahls, Christine"
  19. AU="Dongho Lee"
  20. AU=Houser Steven R.
  21. AU="Morgom M.M."
  22. AU="Jordana-Comajuncosa, Rosa"
  23. AU="Kaushansky, Alexis"
  24. AU="Bhatjiwale, Mohinish"
  25. AU="Velu, Chinavenmeni S"
  26. AU=Trayanova Natalia A
  27. AU=Jimeno-Gonzlez Silvia
  28. AU=Bussolino F
  29. AU="Almulla, Hanan"
  30. AU="Chen, Wenmei"
  31. AU=Zeng Weiqing

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  1. Artikel ; Online: MUKnine OPTIMUM protocol

    Sarah Brown / Debbie Sherratt / Louise Flanagan / Sadie Roberts / Katrina Walker / Guy Pratt / Christina Messiou / Matthew Jenner / Martin Kaiser

    BMJ Open, Vol 11, Iss

    a screening study to identify high-risk patients with multiple myeloma suitable for novel treatment approaches combined with a phase II study evaluating optimised combination of biological therapy in newly diagnosed high-risk multiple myeloma and plasma cell leukaemia

    2021  Band 3

    Abstract: Introduction Multiple myeloma (MM) is a plasma cell tumour with over 5800 new cases each year in the UK. The introduction of biological therapies has improved outcomes for the majority of patients with MM, but in approximately 20% of patients the tumour ... ...

    Abstract Introduction Multiple myeloma (MM) is a plasma cell tumour with over 5800 new cases each year in the UK. The introduction of biological therapies has improved outcomes for the majority of patients with MM, but in approximately 20% of patients the tumour is characterised by genetic changes which confer a significantly poorer prognosis, generally termed high-risk (HR) MM. It is important to diagnose these genetic changes early and identify more effective first-line treatment options for these patients.Methods and analysis The Myeloma UK nine OPTIMUM trial (MUKnine) evaluates novel treatment strategies for patients with HRMM. Patients with suspected or newly diagnosed MM, fit for intensive therapy, are offered participation in a tumour genetic screening protocol (MUKnine a), with primary endpoint proportion of patients with molecular screening performed within 8 weeks. Patients identified as molecularly HR are invited into the phase II, single-arm, multicentre trial (MUKnine b) investigating an intensive treatment schedule comprising bortezomib, lenalidomide, daratumumab, low-dose cyclophosphamide and dexamethasone, with single high-dose melphalan and autologous stem cell transplantation (ASCT) followed by combination consolidation and maintenance therapy. MUKnine b primary endpoints are minimal residual disease (MRD) at day 100 post-ASCT and progression-free survival. Secondary endpoints include response, safety and quality of life. The trial uses a Bayesian decision rule to determine if this treatment strategy is sufficiently active for further study. Patients identified as not having HR disease receive standard treatment and are followed up in a cohort study. Exploratory studies include longitudinal whole-body diffusion-weighted MRI for imaging MRD testing.Ethics and dissemination Ethics approval London South East Research Ethics Committee (Ref: 17/LO/0022, 17/LO/0023). Results of studies will be submitted for publication in a peer-reviewed journal.Trial registration number ISRCTN16847817, May 2017; Pre-results.
    Schlagwörter Medicine ; R
    Thema/Rubrik (Code) 610
    Sprache Englisch
    Erscheinungsdatum 2021-03-01T00:00:00Z
    Verlag BMJ Publishing Group
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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  2. Artikel ; Online: The MUK eight protocol

    Samantha Hinsley / Katrina Walker / Debbie Sherratt / Lucy Bailey / Sadie Reed / Louise Flanagan / Sophie McKee / Fiona Brudenell Straw / Bryony Dawkins / David Meads / Holger W. Auner / Martin F. Kaiser / Mark Cook / Sarah Brown / Gordon Cook / on behalf of the Myeloma UK Clinical Trials Network

    Trials, Vol 21, Iss 1, Pp 1-

    a randomised phase II trial of cyclophosphamide and dexamethasone in combination with ixazomib, in relapsed or refractory multiple myeloma (RRMM) patients who have relapsed after treatment with thalidomide, lenalidomide and a proteasome inhibitor

    2020  Band 11

    Abstract: Abstract Background Multiple myeloma is a plasma cell tumour with approximately 5500 new cases in the UK each year. Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from ...

    Abstract Abstract Background Multiple myeloma is a plasma cell tumour with approximately 5500 new cases in the UK each year. Ixazomib is a next generation inhibitor of the 20S proteasome and is thought to be an effective treatment for those who have relapsed from bortezomib. The combination of cyclophosphamide and dexamethasone (CD) is a recognised treatment option for patients with relapsed refractory multiple myeloma (RRMM) who have relapsed after treatment with bortezomib and lenalidomide, whilst also often being combined with newer proteasome inhibitors. The most apparent combination for ixazomib is therefore with CD. Methods MUK eight is a randomised, controlled, open, parallel group, multi-centre phase II trial that will recruit patients with RRMM who have relapsed after treatment with thalidomide, lenalidomide, and a proteasome inhibitor. The primary objective of the trial is to evaluate whether ixazomib in combination with cyclophosphamide and dexamethasone (ICD) has improved clinical activity compared to CD in terms of progression-free survival (PFS). Secondary objectives include comparing toxicity profiles and the activity and cost-effectiveness of both treatments. Since opening, the trial has been amended to allow all participants who experience disease progression (as per the IMWG criteria) on the CD arm to subsequently switch to receive ICD treatment, once progression has been confirmed with two clinical members of the Trial Management Group (TMG). This ‘switch’ phase of the study is exploratory and will assess second progression-free survival measured from randomisation to second disease progression (PFS2) and progression-free survival from the point of switching to second disease progression (PFS Switch) in participants who switch from CD to ICD treatment. Discussion Development of ixazomib offers the opportunity to further investigate the value of proteasome inhibition through oral administration in the treatment of RRMM. Previous studies investigating the safety and efficacy of ICD in patients with RRMM ...
    Schlagwörter Medicine (General) ; R5-920
    Thema/Rubrik (Code) 610
    Sprache Englisch
    Erscheinungsdatum 2020-10-01T00:00:00Z
    Verlag BMC
    Dokumenttyp Artikel ; Online
    Datenquelle BASE - Bielefeld Academic Search Engine (Lebenswissenschaftliche Auswahl)

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