406
Participants
Start Date
March 20, 2017
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2027
Ixazomib, thalidomide, & dexamethasone (ITD) re-induction
"4 - 6 ITD 28-day cycles as follows:~* Ixazomib 4mg capsule on days 1, 8 and 15~* Thalidomide 100mg capsule on days 1-28~* Dexamethasone 40mg tablets on days 1, 8, 15 and 22"
Conventional autologous stem cell transplant (ASCT-con)
Melphalan 200mg/m2 IV infusion on Day -1, followed by ASCT on Day 0.
Augmented autologous stem cell transplant (ASCT-aug)
Melphalan 100mg/m2 IV infusion on Day -3 and Day -2 plus ixazomib 4mg capsules on Day -4 and Day -1. ASCT will then be given on Day 0.
ITD consolidation and ixazomib maintenance vs. No further therapy
"Participants will be randomised to either 'no further therapy' or 'ITD consolidation and ixazomib maintenance'. Participants randomised to 'no further treatment' will not receive any further treatment but will be followed up at 8 weeks post randomisation 2 and at 3-monthly clinic visits until disease progression.~Participants randomised to ITD consolidation and ixazomib maintenance will receive:~Two 28-day cycles of ITD consolidation (same doses as in ITD re-induction). This will be followed by ixazomib maintenance as follows: Ixazomib 4mg capsule on days 1, 8 and 15 of each 28-day cycle until disease progression."
RECRUITING
Aberdeen Royal Infirmary, Aberdeen
RECRUITING
Monklands Hospital, Airdrie
RECRUITING
University Hospital Ayr, Ayr
RECRUITING
Barnsley Hospital, Barnsley
RECRUITING
Basingstoke & North Hampshire Hospital, Basingstoke
RECRUITING
Royal United Hospital, Bath
RECRUITING
Good Hope Hospital, Birmingham
RECRUITING
Heartlands Hospital, Birmingham
RECRUITING
Queen Elizabeth Hospital, Birmingham
RECRUITING
Blackpool Victoria Hospital, Blackpool
RECRUITING
Pilgrim Hospital, Boston
RECRUITING
Royal Bournemouth Hospital, Bournemouth
RECRUITING
Bradford Royal Infirmary, Bradford
RECRUITING
Bristol Haematology & Oncology Centre, Bristol
RECRUITING
Southmead Hospital, Bristol
RECRUITING
Queen's Hospital, Burton-on-Trent
RECRUITING
Addenbrooke's Hospital, Cambridge
RECRUITING
St Helier Hospital, Carshalton
RECRUITING
Cheltenham General Hospial, Cheltenham
RECRUITING
Countess of Chester Hospital, Chester
RECRUITING
Chesterfield Royal Hospital, Chesterfield
RECRUITING
St Richards Hospital, Chichester
RECRUITING
University Hospital Coventry, Coventry
RECRUITING
Royal Derby Hospital, Derby
RECRUITING
Dewsbury Hospital, Dewsbury
RECRUITING
Russells Hall Hospital, Dudley
RECRUITING
Ninewells Hospital, Dundee
RECRUITING
Hairmyres Hospital, East Kilbride
RECRUITING
Western General Hospital, Edinburgh
RECRUITING
Beatson Cancer Centre, Glasgow
RECRUITING
New Victoria Hospital, Glasgow
RECRUITING
Gloucestershire Royal Hospital, Gloucester
RECRUITING
Grantham and District Hospital, Grantham
RECRUITING
Diana Princess of Wales Hospital, Grimsby
RECRUITING
Calderdale Royal Hospital, Halifax
RECRUITING
Harrogate District Hospital, Harrogate
RECRUITING
Huddersfield Royal Infirmary, Huddersfield
RECRUITING
Castle Hill Hospital, Hull
RECRUITING
Raigmore Hospital, Inverness
RECRUITING
Ipswich Hospital, Ipswich
RECRUITING
Kidderminster Hospital, Kidderminster
RECRUITING
University Hospital Crosshouse, Kilmarnock
RECRUITING
St James's University Hospital, Leeds
RECRUITING
Leicester Royal Infirmary, Leicester
RECRUITING
Lincoln County Hospital, Lincoln
RECRUITING
Royal Liverpool University Hospital, Liverpool
RECRUITING
University Hospital Aintree, Liverpool
RECRUITING
Guys and St Thomas's Hospital, London
RECRUITING
Kings College Hospital, London
RECRUITING
Royal Marsden Hospital, London
RECRUITING
St Barts Hospital, London
RECRUITING
University College London Hospital, London
RECRUITING
Maidstone Hospital, Maidstone
RECRUITING
Manchester Royal Infirmary, Manchester
RECRUITING
The Christie, Manchester
RECRUITING
Borders General Hospital, Melrose
RECRUITING
James Cook University Hospital, Middlesbrough
RECRUITING
Milton Keynes General Hospital, Milton Keynes
RECRUITING
Freeman Hospital, Newcastle
RECRUITING
North Tyneside General Hospital, North Shields
RECRUITING
Norfolk & Norwich University Hospital, Norwich
RECRUITING
Nottingham City Hospital, Nottingham
RECRUITING
Royal Oldham Hospital, Oldham
RECRUITING
Churchill Hospital, Oxford
RECRUITING
Royal Alexandra Hospital, Paisley
RECRUITING
Derriford Hospital, Plymouth
RECRUITING
Pontefract Hospital, Pontefract
RECRUITING
Whiston Hospital, Prescot
RECRUITING
Royal Berkshire Hospital, Reading
RECRUITING
Redditch Hospital, Redditch
RECRUITING
Tunbridge Wells Hospital, Royal Tunbridge Wells
RECRUITING
Salford Royal Hospital, Salford
RECRUITING
Salisbury Hospital, Salisbury
RECRUITING
Scunthorpe General Hospital, Scunthorpe
RECRUITING
Royal Hallamshire Hospital, Sheffield
RECRUITING
Southampton General Hospital, Southampton
RECRUITING
St Helens Hospital, St Helens
RECRUITING
Stafford County Hospital, Stafford
RECRUITING
Stepping Hill Hospital, Stockport
RECRUITING
Royal Stoke University Hospital, Stoke-on-Trent
NOT_YET_RECRUITING
Sunderland Royal Hospital, Sunderland
RECRUITING
King's Mill Hospital, Sutton in Ashfield
RECRUITING
Singleton Hospital, Swansea
RECRUITING
Musgrove Park Hospital, Taunton
RECRUITING
St George's Hospital, Tooting
RECRUITING
Pinderfields General Hospital, Wakefield
RECRUITING
Royal Hampshire County Hospital, Winchester
RECRUITING
Wishaw Hospital, Wishaw
RECRUITING
New Cross Hospital, Wolverhampton
RECRUITING
Worcestershire Royal Hospital, Worcester
RECRUITING
Worthing Hospital, Worthing
Collaborators (2)
Cancer Research UK
OTHER
Takeda
INDUSTRY
University of Leeds
OTHER