- Active, not recruiting
NCT01554852: Phase 3- Thalidomide, Lenalidomide, Carfilzomib, Bortezomib, Vorinostat-NDMM Myeloma XI
Updated: Aug 30, 2022
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!
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
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
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
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.
2017 ASCO Annual Meeting ; ASCO Abstract 8009
Lenalidomide induction and maintenance therapy for transplant eligible myeloma patients: Results of the Myeloma XI study.
J Clin Oncol; 2015 Nov
Mutational Spectrum, Copy Number Changes, and Outcome: Results of a Sequencing Study of Patients With Newly Diagnosed Myeloma
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
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
NCT03188172: Phase 2 - MUK Nine b: OPTIMUM Treatment Protocol (MUKnineb)
Location
Europe
United Kingdom
University of Leeds