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NCT01554852: Phase 3- Thalidomide, Lenalidomide, Carfilzomib, Bortezomib, Vorinostat-NDMM Myeloma XI

Updated: Aug 30, 2022

Myeloma XI

Myeloma XI

The purpose of this study is to compare a standard chemotherapy regimen of cyclophosphamide, dexamethasone plus thalidomide with a newer regimen of cyclophosphamide, dexamethasone plus lenalidomide with or without carfilzomib.

Patients who do not have the best response to their initial treatment may then also be given a combination of cyclophosphamide, dexamethasone plus bortezomib.

Patients who are relatively fit may, on their doctor's advice, go on to receive more intensive chemotherapy, supported with a transplant of their own blood cells. This is standard treatment which patients may be offered anyway even if they didn't take part in this study.

After maximal response has been achieved with the treatment described above, and as long as the myeloma has not got worse, patients will be treated with either long-term lenalidomide, lenalidomide with vorinostat, or receive no further treatment, with close observation.


Sponsor

University of Leeds


Collaborators

Celgene

Merck Sharp & Dohme Corp.

Amgen


Multiple Locations

UK Study

 

ClinicalTrials.gov Identifier: NCT01554852


Official Title: Randomised Comparisons, in Myeloma Patients of All Ages, of Thalidomide, Lenalidomide, Carfilzomib and Bortezomib Induction Combinations, and of Lenalidomide and Combination Lenalidomide Vorinostat as Maintenance (Myeloma XI)


First Posted : March 15, 2012


Click here for details on ClinicalTrials.gov

 

Drug: Induction (intensive pathway) - cyclophosphamide, lenalidomide, & dexamethasone (CRD) regimen Drug: Induction (intensive pathway) - cyclophosphamide, thalidomide, & dexamethasone (CTD) regimen Drug: Induction (intensive pathway) - carfilzomib, cyclophosphamide, lenalidomide, & dexamethasone (CCRD) regimen

Drug: Induction (non-intensive pathway) - cyclophosphamide, lenalidomide, & dexamethasone attenuated (CRDa) regimen

Drug: Induction (non-intensive pathway) - cyclophosphamide, thalidomide, & dexamethasone attenuated (CTDa) regimen

Drug: Consolidation (intensive & non-intensive pathways) - bortezomib, cyclophosphamide, & dexamethasone (VCD) regimen

Drug: Maintenance (intensive & non-intensive pathways) - lenalidomide maintenance

Drug: Maintenance (intensive & non-intensive pathways - protocol v5.0 only) - lenalidomide plus vorinostat maintenance

Drug: High dose melphalan therapy and autologous stem cell transplant (intensive pathway only)

 

J Clin Oncol; 2022 Jun 30

Modern Myeloma Therapy + Sustained Minimal Residual Disease-Negative = (Functional) Cure!

Click here for details

 

Lancet Haematol;2019 Dec

Response-adapted intensification with cyclophosphamide, bortezomib, and dexamethasone versus no intensification in patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial

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653 Myeloma| November 13, 2019

Myeloma XI Trial for Newly Diagnosed Multiple Myeloma (NDMM); Long Term Second Primary Malignancy (SPM) Incidence in the Context of Lenalidomide Maintenance

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Lancet Oncol;2019 Jan

Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial

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Year: 2017 - Session type: Clinical Trials Showcase

Abstracts from the NCRI Cancer Conference

The NCRI Myeloma XI study: a large adaptive randomised clinical trial successfully answering a diverse range of key questions in multiple myeloma.

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2017 ASCO Annual Meeting ; ASCO Abstract 8009

Lenalidomide induction and maintenance therapy for transplant eligible myeloma patients: Results of the Myeloma XI study.

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J Clin Oncol; 2015 Nov

Mutational Spectrum, Copy Number Changes, and Outcome: Results of a Sequencing Study of Patients With Newly Diagnosed Myeloma

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653. Myeloma: Therapy, excluding Transplantation| November 15, 2013

Lenalidomide Combined With Cyclophosphamide and Dexamethasone Is Effective and Well Tolerated Induction Treatment For Newly Diagnosed Myeloma Patients Of All Ages

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BMJ Open: March 24, 2021

MUKnine 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

https://bmjopen.bmj.com/content/bmjopen/11/3/e046225.full.pdf


NCT03188172: Phase 2 - MUK Nine b: OPTIMUM Treatment Protocol (MUKnineb)

NCT03188172: Phase 2 - MUK Nine b: OPTIMUM Treatment Protocol (MUKnineb)

 

Location

Europe

United Kingdom

University of Leeds


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