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dc.contributor.authorBrown, S
dc.contributor.authorSherratt, D
dc.contributor.authorHinsley, S
dc.contributor.authorFlanagan, L
dc.contributor.authorRoberts, S
dc.contributor.authorWalker, K
dc.contributor.authorHall, A
dc.contributor.authorPratt, G
dc.contributor.authorMessiou, C
dc.contributor.authorJenner, M
dc.contributor.authorKaiser, M
dc.contributor.authorMyeloma UK Early Phase Clinical Trial Network
dc.date.accessioned2021-06-10T15:22:48Z
dc.date.available2021-06-10T15:22:48Z
dc.date.issued2021-03-24
dc.identifier.citationBMJ open, 2021, 11 (3), pp. e046225 - ?en_US
dc.identifier.issn2044-6055
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4606
dc.identifier.eissn2044-6055en_US
dc.identifier.eissn2044-6055
dc.identifier.doi10.1136/bmjopen-2020-046225en_US
dc.identifier.doi10.1136/bmjopen-2020-046225
dc.description.abstract<h4>Introduction</h4>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.<h4>Methods and analysis</h4>The Myeloma UK <i>nine</i> OPTIMUM trial (MUK<i>nine</i>) 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 (MUK<i>nine a</i>), 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 (MUK<i>nine b</i>) 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. MUK<i>nine b</i> 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.<h4>Ethics and dissemination</h4>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.<h4>Trial registration number</h4>ISRCTN16847817, May 2017; Pre-results.en_US
dc.formatElectronicen_US
dc.format.extente046225 - ?en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0en_US
dc.subjectMyeloma UK Early Phase Clinical Trial Networken_US
dc.subjectHumansen_US
dc.subjectMultiple Myelomaen_US
dc.subjectDexamethasoneen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectHematopoietic Stem Cell Transplantationen_US
dc.subjectTransplantation, Autologousen_US
dc.subjectBayes Theoremen_US
dc.subjectCohort Studiesen_US
dc.subjectQuality of Lifeen_US
dc.subjectLondonen_US
dc.subjectLeukemia, Plasma Cellen_US
dc.subjectMulticenter Studies as Topicen_US
dc.subjectClinical Trials, Phase II as Topicen_US
dc.titleMUK<i>nine</i> OPTIMUM protocol: 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.en_US
dc.typeJournal Article
dcterms.dateAccepted2021-02-09
rioxxterms.versionVoRen_US
rioxxterms.versionofrecord10.1136/bmjopen-2020-046225en_US
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by-nc/4.0en_US
rioxxterms.licenseref.startdate2021-03-24
dc.relation.isPartOfBMJ openen_US
pubs.issue3en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Myeloma Group
pubs.publication-statusPublisheden_US
pubs.volume11en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMyeloma Group
dc.contributor.icrauthorMessiou, Christinaen_US
dc.contributor.icrauthorKaiser, Martinen_US


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