- Active, not recruiting
NCT03188172: Phase 2 - MUK Nine b: OPTIMUM Treatment Protocol (MUKnineb)
Updated: Feb 10
MUKnineb Study OPTIMUM
To determine whether a combination of four novel agents bortezomib(Velcade), lenalidomide (Revlimid), Daratumumab (Darzalex) & dexamethasone in combination with low-dose cyclophosphamide is sufficiently active in a high risk population of myeloma patients, to take forward into a phase III trial compared to standard treatment.
MUK Nine b: OPTIMUM Treatment Protocol (MUKnineb)
Sponsor
University of Leeds
Collaborators
Multiple Locations
UK Study
ClinicalTrials.gov Identifier: NCT03188172
Official Title: MUK Nine b: OPTIMUM. A Phase II Study Evaluating Optimised Combination of Biological Therapy in Newly Diagnosed High Risk Multiple Myeloma and Plasma Cell Leukaemia
First Posted: June 15, 2017
Click here for details on ClinicalTrials.gov
Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Lenalidomide
Drug: Daratumumab
Drug: Dexamethasone
Drug: Melphalan
Drug: Filgrastim
Patients treated in OPTIMUM with Dara-CVRd induction, V-augmented ASCT and Dara-VRd consolidation, compared to the MyXI prior.
465 Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, Dexamethasone (Dara-CVRd), V-Augmented Autologous Stem Cell Transplant (V-ASCT) and Dara-Vrd Consolidation in Ultra-High Risk (UHiR) Newly Diagnosed Myeloma (NDMM) and Primary Plasma Cell Leukemia (pPCL) Compared with Myeloma XI/XI+ Trial Treatment for Uhir MM: The UK Optimum/Muknine TrialClinically Relevant Abstract
Program: Oral and Poster Abstracts
Type: Oral
Session: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials; treatment of NDMM and amyloidosis patients
Hematology Disease Topics & Pathways:
Clinical Trials, Biological, Antibody Therapy, Genomics, Adults, Translational Research, Clinical Research, Plasma Cell Disorders, Clinically Relevant, Diseases, Therapies, Lymphoid Malignancies, Monoclonal Antibody Therapy, Biological Processes, Genomic Profiling, Technology and Procedures, Study Population, Molecular Testing, Diversity, Equity, and Inclusion (DEI)
Sunday, December 12, 2021: 12:30 PM
Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma
Insights Imaging
2022;Jul 28
BMJ Open: 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
BMJ Open;2021 Mar 24
NCT01554852: Phase 3- Thalidomide, Lenalidomide, Carfilzomib, Bortezomib, Vorinostat-NDMM Myeloma XI
Locations
United Kingdom
Principal Investigator: Martin Kaiser University of Leeds