• Recruiting

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

Updated: Oct 21

MUKnineb Study OPTIMUM

OPTIMUM-MUK Nine trial

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

Myeloma UK

Celgene

Janssen, LP


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

 

Daratumumab : National Cancer Institute

Daratumumab : MedlinePlus Drug Information


Daratumumab and Hyaluronidase-fihj Injection: National Cancer Institute

Daratumumab and Hyaluronidase-fihj Injection: MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information


Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information

 

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


Learn more

 

Implementation of Whole-Body MRI (MY-RADS) within the OPTIMUM/MUKnine multi-centre clinical trial for patients with myeloma

Insights Imaging

2022;Jul 28

https://pubmed.ncbi.nlm.nih.gov/35900614/

 

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

https://pubmed.ncbi.nlm.nih.gov/33762245/

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

 

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

Myeloma XI (themyelomaclinicaltrials.com)

 

Locations

United Kingdom

Principal Investigator: Martin Kaiser University of Leeds







Posts Archive