This tool will take you through current, open clinical trials in the UK and help you to understand which trials may be suitable for you. With any clinical trial you will need to be referred by your Health Care Specialist, always seek advice when considering clinical trials.

Further information can be found on our website under Clincial Trials and Novel Drugs or if you would like to speak to someone please call the Myeloma UK infoline on: 0800 980 3332

The Myeloma Trial Finder is intended only to provide information about clinical trials currently available in the UK. Trials included on Myeloma Trial Finder are not necessarily endorsed by Myeloma UK. Clinical trials involve inherent risks and any decision to participate, or not participate, in a clinical trial should be taken only after a careful assessment of the risks involved in it. Please speak to your haematologist if you are interested in taking part in a clinical trial. To the fullest extent permitted by law Myeloma UK excludes all liability howsoever arising (including negligence) as a consequence of, or in connection with, the use of information provided by Myeloma Trial Finder

There are currently 21 open trials. In 121 locations

What is a Clinical Trial?

Step 3: View Details

Trial Title:

MUK nine b: OPTIMUM

Treatments:

Bortezomib (Velcade®)
Dexamethasone
Daratumumab (Darzalex®)
Dexamethasone
Cyclophosphamide

Myeloma stage:

High risk myeloma

Trial phase:

II

Summary

Summary:

The aim of this study is to determine whether a combination of bortezomib, lenalidomide, Daratumumab and dexamethasone, together with low-dose cyclophosphamide, is effective as a treatment for patients with high risk myeloma.

Locations

Locations:

The Royal Marsden Hospital, Sutton;
Barts Health NHS Trust, London;
Leeds Teaching Hospitals NHS Trust, Leeds;
King's College Hospital, London;
Southampton General Hospital, Southampton;
Guy's Hospital, London;
University Hospitals of Leicester NHS Trust;
University Hospitals Bristol NHS Foundation Trust;
Queen Elizabeth Hospital, Birmingham;
Heartlands Hospital, Birmingham;
Manchester Royal Infirmary, Manchester;
Belfast City Hospital, Northern Ireland;
Ninewells Hospital, Dundee;
The Beatson Institute, Glasgow;
Addenbrooke's Hospital, Cambridge;
Oxford Radcliffe Hospital, Oxford;
Nottingham University Hospitals NHS Trust

Who can enter the study?

Who can enter the study?:

This trial is for patients who have been classified as having high risk myeloma by the Institute of Cancer Research (ICR) through the MUK nine a screening protocol. This includes identification of biomarkers, including genetic, epigenetic or protein markers that are associated with a poor prognosis and response to treatment.

 

What's involved?

What's involved?:

All patients enrolled in this trail with receive the following treatment:

  • Induction: 6 x 21 day cycle

Cyclophosphamide (500mg) is taken by mouth on days 1 and 8 of cycle, and lenalidomide (25mg) on days 1 -14. Bortezomib (1.3mg/m) is given by subcutaneous injection and dexamethasone (20-40mg) is taken by mouth, or intravenously (into the vein) on days 1, 4, 8 and 11. During cycle 1 and 2, Daratumumab (16mg/kg) is given intravenously on days 1, 8 and 15, and during cycles 3 – 6 it is given on day 1 only.

 

  • Autologous stem cell transplant (ASCT)

 

  • Consolidation part 1: 6 x 28 day cycle

Lenalidomide (25mg) is taken by mouth on days 1 – 21 of the cycle, and dexamethasone (20-40mg) on days 1, 8, 15 and 22. Bortezomib (1.3mg/m) is given by subcutaneous injection on days 1, 8, 15 and 22. Daratumumab (16mg/kg) is given intravenously on day 1 of cycle.

 

  • Consolidation part 212 x 28 day cycle

Lenalidomide (25mg) is taken by mouth on days 1 – 21 of cycle. Bortezomib (1.3mg/m) is given by subcutaneous injection on days 1, 8 and 15 and Daratumumab (16mg/kg) is given intravenously on day 1 of cycle.

 

  • Maintenance treatment: 28 day cycle until signs of disease progression

Lenalidomide (10mg) is taken by mouth on days 1 – 21 of cycle, and Daratumumab

 

Patients are required to visit the outpatient clinic for regular blood test and check-ups.

Clinical Information

Clinical Information
(for Medical Professionals):

The purpose of this study is to determine whether a combination of bortezomib, lenalidomide, daratumumab and dexamethasone, together with low-dose cyclophosphamide, is sufficiently active in high risk myeloma to progress to a Phase III trial, where it can be compared to standard treatments.

 

For more information, click here

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