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dc.contributor.authorJackson, GH
dc.contributor.authorDavies, FE
dc.contributor.authorPawlyn, C
dc.contributor.authorCairns, DA
dc.contributor.authorStriha, A
dc.contributor.authorCollett, C
dc.contributor.authorWaterhouse, A
dc.contributor.authorJones, JR
dc.contributor.authorKishore, B
dc.contributor.authorGarg, M
dc.contributor.authorWilliams, CD
dc.contributor.authorKarunanithi, K
dc.contributor.authorLindsay, J
dc.contributor.authorAllotey, D
dc.contributor.authorShafeek, S
dc.contributor.authorJenner, MW
dc.contributor.authorCook, G
dc.contributor.authorRussell, NH
dc.contributor.authorKaiser, MF
dc.contributor.authorDrayson, MT
dc.contributor.authorOwen, RG
dc.contributor.authorGregory, WM
dc.contributor.authorMorgan, GJ
dc.contributor.authorUK NCRI Haematological Oncology Clinical Studies Group
dc.date.accessioned2020-07-06T14:31:27Z
dc.date.issued2020-06-04
dc.identifier.citationHaematologica, 2020
dc.identifier.issn0390-6078
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3813
dc.identifier.eissn1592-8721
dc.identifier.doi10.3324/haematol.2020.247130
dc.description.abstractThe optimal way to use immunomodulatory drugs as components of induction and maintenance therapy for multiple myeloma is unresolved. We addressed this question in a large phase III randomized trial, Myeloma XI. Patients with newly diagnosed multiple myeloma (n = 2042) were randomized to induction therapy with cyclophosphamide, thalidomide, and dexamethasone (CTD) or cyclophosphamide, lenalidomide, and dexamethasone (CRD). Additional intensification therapy with cyclophosphamide, bortezomib and dexamethasone (CVD) was administered before ASCT to patients with a suboptimal response to induction therapy using a response-adapted approach. After receiving high-dose melphalan with autologous stem cell transplantation (ASCT), eligible patients were further randomized to receive either lenalidomide alone or observation alone. Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). The CRD regimen was associated with significantly longer PFS (median: 36 vs. 33 months; hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.75-0.96; P = 0.0116) and OS (3-year OS: 82.9% vs. 77.0%; HR, 0.77; 95% CI, 0.63-0.93; P = 0.0072) compared with CTD. The PFS and OS results favored CRD over CTD across all subgroups, including patients with International Staging System stage III disease (HR for PFS, 0.73; 95% CI, 0.58-0.93; HR for OS, 0.78; 95% CI, 0.56-1.09), high-risk cytogenetics (HR for PFS, 0.60; 95% CI, 0.43-0.84; HR for OS, 0.70; 95% CI, 0.42-1.15) and ultra high-risk cytogenetics (HR for PFS, 0.67; 95% CI, 0.41-1.11; HR for OS, 0.65; 95% CI, 0.34-1.25). Among patients randomized to lenalidomide maintenance (n = 451) or observation (n = 377), maintenance therapy improved PFS (median: 50 vs. 28 months; HR, 0.47; 95% CI, 0.37-0.60; P < 0.0001). Optimal results for PFS and OS were achieved in the patients who received CRD induction and lenalidomide maintenance. The trial was registered with the EU Clinical Trials Register (EudraCT 2009-010956-93) and ISRCTN49407852.
dc.formatPrint-Electronic
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectUK NCRI Haematological Oncology Clinical Studies Group
dc.titleLenalidomide before and after ASCT for transplant-eligible patients of all ages in the randomized, phase III, Myeloma XI trial.
dc.typeJournal Article
dcterms.dateAccepted2020-05-28
rioxxterms.versionofrecord10.3324/haematol.2020.247130
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2020-06-04
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfHaematologica
pubs.notesNot known
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/Cancer Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics/Myeloma Biology and Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Myeloma Group
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/Cancer Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Therapeutics/Myeloma Biology and Therapeutics
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Myeloma Group
pubs.publication-statusPublished
pubs.embargo.termsNot known
icr.researchteamMyeloma Biology and Therapeuticsen_US
icr.researchteamMyeloma Groupen_US
dc.contributor.icrauthorPawlyn, Charlotteen
dc.contributor.icrauthorKaiser, Martinen


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