740
Participants
Start Date
August 4, 2020
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2024
R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm
"In the reactive arm at Randomisation 1, participants will receive IRD induction therapy with standard up-front dosing, with toxicity assessed at each cycle and doses adjusted in accordance with the guidelines given in the trial protocol. All participants will be given the following starting doses:~Ixazomib: 4mg/day on days 1, 8 and 15, taken orally~Lenalidomide: 25mg/day on days 1-21, taken orally~Dexamethasone: 40mg on days 1, 8, 15 and 22 for participants aged ≤75 years, or 20mg on days 1, 8, 15 and 22 for participants aged \> 75 years; taken orally~Participants will receive this dosing regimen for 12 cycles of induction treatment, in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days."
R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm
"In the adaptive arm at Randomisation 1, participants will receive IRD induction therapy with up-front dose reductions adjusted according to their frailty score: fit, unfit, or frail. The starting doses for each frailty category are described below:~1. Fit category:~ Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 25mg on days 1-21, taken orally Dexamethasone: 40mg on days 1, 8, 15 and 22, taken orally~2. Unfit category:~ Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 15mg on days 1-21, taken orally Dexamethasone: 20mg on days 1, 8, 15 and 22, taken orally~3. Frail category:~Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 10mg on days 1-21, taken orally Dexamethasone: 10mg on days 1, 8, 15 and 22, taken orally~Participants will receive this dosing regimen for 12 cycles of induction treatment, in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days."
R2: Lenalidomide plus placebo maintenance
"Participants randomised to receive lenalidomide plus placebo maintenance at Randomisation 2 will receive the following starting doses:~Lenalidomide: 10mg\*/day on days 1-21, taken orally Placebo: 4mg\*/day on days 1, 8 and 15~\* or final dose administered at the end of induction treatment if lower.~This dosing regimen is continued for every maintenance cycle. Participants will continue maintenance treatment until disease progression or intolerance/unacceptable toxicity. Each maintenance cycle is 28 days.~Randomisation 2 is double-blind - participants and their treating clinicians will be blinded to maintenance allocation."
R2: Lenalidomide + ixazomib maintenance
"Participants randomised to receive lenalidomide plus ixazomib maintenance at Randomisation 2 will receive the following starting doses:~Lenalidomide: 10mg\*/day on days 1-21, taken orally Ixazomib: 4mg\*/day on days 1, 8 and 15~\* or final dose administered at the end of induction treatment if lower.~This dosing regimen is continued for every maintenance cycle. Participants will continue maintenance treatment until disease progression or intolerance/unacceptable toxicity. Each maintenance cycle is 28 days.~Randomisation 2 is double-blind - participants and their treating clinicians will be blinded to maintenance allocation."
RECRUITING
Aberdeen Royal Infirmary, Aberdeen
NOT_YET_RECRUITING
Nevill Hall Hospital, Abergavenny
NOT_YET_RECRUITING
Wrightington Hosptial, Appley Bridge
NOT_YET_RECRUITING
Ysbyty Gwynedd, Bangor
NOT_YET_RECRUITING
North Devon District Hospital, Barnstaple
NOT_YET_RECRUITING
Furness General Hospital, Barrow in Furness
NOT_YET_RECRUITING
Basingstoke and North Hampshire Hospital, Basingstoke
NOT_YET_RECRUITING
Royal United Hospital, Bath
NOT_YET_RECRUITING
Belfast City Hospital, Belfast
NOT_YET_RECRUITING
Birmingham Heartlands Hospital, Birmingham
NOT_YET_RECRUITING
Queen Elizabeth Hospital, Birmingham
NOT_YET_RECRUITING
Royal Blackburn Hospital, Blackburn
RECRUITING
Blackpool Victoria Hospital, Blackpool
NOT_YET_RECRUITING
Royal Bolton Hospital, Bolton
NOT_YET_RECRUITING
Pilgrim Hospital, Boston
RECRUITING
Royal Bournemouth Hospital, Bournemouth
NOT_YET_RECRUITING
Bradford Royal Infirmary, Bradford
RECRUITING
Bristol Haematology and Oncology Centre, Bristol
NOT_YET_RECRUITING
Southmead Hospital, Bristol
NOT_YET_RECRUITING
Queen's Hospital, Burton-on-Trent
RECRUITING
Kent and Canterbury Hospital, Canterbury
NOT_YET_RECRUITING
Chelmsford & Essex Hospital, Chelmsford
RECRUITING
Cheltenham General Hospital, Cheltenham
NOT_YET_RECRUITING
Countess of Chester Hospital, Chester
NOT_YET_RECRUITING
St Richard's Hospital, Chichester
NOT_YET_RECRUITING
Colchester General Hospital, Colchester
NOT_YET_RECRUITING
University Hospital Coventry, Coventry
NOT_YET_RECRUITING
Croydon University Hospital, Croydon
NOT_YET_RECRUITING
Royal Derby Hospital, Derby
NOT_YET_RECRUITING
Dorset County Hospital, Dorchester
NOT_YET_RECRUITING
Russells Hall Hospital, Dudley
NOT_YET_RECRUITING
Ninewells Hospital, Dundee
NOT_YET_RECRUITING
Western General Hospital, Edinburgh
NOT_YET_RECRUITING
Royal Devon & Exeter Hospital, Exeter
NOT_YET_RECRUITING
Medway Maritime Hospital, Gillingham
NOT_YET_RECRUITING
Gloucestershire Royal Hospital, Gloucester
NOT_YET_RECRUITING
Grantham and District Hospital, Grantham
NOT_YET_RECRUITING
Diana Princess of Wales Hospital, Grimsby
NOT_YET_RECRUITING
Royal Surrey County Hospital, Guildford
NOT_YET_RECRUITING
Calderdale Royal Hospital, Halifax
NOT_YET_RECRUITING
Harrogate District Hospital, Harrogate
NOT_YET_RECRUITING
Withybush General Hospital, Haverfordwest
NOT_YET_RECRUITING
Hereford County Hospital, Hereford
NOT_YET_RECRUITING
Huddersfield Royal Infirmary, Huddersfield
NOT_YET_RECRUITING
Castle Hill Hospital, Hull
NOT_YET_RECRUITING
Raigmore Hospital, Inverness
NOT_YET_RECRUITING
Ipswich Hospital, Ipswich
NOT_YET_RECRUITING
Airedale Hospital, Keighley
NOT_YET_RECRUITING
Westmorland General Hospital, Kendal
NOT_YET_RECRUITING
Kettering General Hospital, Kettering
NOT_YET_RECRUITING
Kidderminster Hospital & Treatment Centre, Kidderminster
NOT_YET_RECRUITING
Victoria Hospital, Kirkcaldy
NOT_YET_RECRUITING
Royal Lancaster Infirmary, Lancaster
NOT_YET_RECRUITING
St James's University Hospital, Leeds
NOT_YET_RECRUITING
Leicester Royal Infirmary, Leicester
NOT_YET_RECRUITING
Lincoln County Hospital, Lincoln
NOT_YET_RECRUITING
Aintree University Hospital, Liverpool
NOT_YET_RECRUITING
Royal Liverpool Hospital, Liverpool
NOT_YET_RECRUITING
Guy's Hospital, London
NOT_YET_RECRUITING
King's College Hospital, London
NOT_YET_RECRUITING
Queen Elizabeth Hospital Greenwich, London
NOT_YET_RECRUITING
St Bartholomew's Hospital, London
RECRUITING
University College Hospital, London
NOT_YET_RECRUITING
University Hospital Lewisham, London
NOT_YET_RECRUITING
Maidstone Hospital, Maidstone
RECRUITING
Manchester Royal Infirmary, Manchester
NOT_YET_RECRUITING
James Cook University Hospital, Middlesbrough
RECRUITING
Freeman Hospital, Newcastle
NOT_YET_RECRUITING
Royal Gwent Hospital, Newport
NOT_YET_RECRUITING
North Tyneside General Hospital, North Shields
NOT_YET_RECRUITING
Nottingham City Hospital, Nottingham
NOT_YET_RECRUITING
Royal Oldham Hospital, Oldham
NOT_YET_RECRUITING
Princess Royal University Hospital, Orpington
NOT_YET_RECRUITING
Peterborough City Hospital, Peterborough
NOT_YET_RECRUITING
Derriford Hospital, Plymouth
NOT_YET_RECRUITING
Whiston Hospital, Prescot
NOT_YET_RECRUITING
Royal Preston Hospital, Preston
RECRUITING
Royal Berkshire Hospital, Reading
NOT_YET_RECRUITING
Alexandra Hospital, Redditch
NOT_YET_RECRUITING
Glan Clwyd Hospital, Rhyl
NOT_YET_RECRUITING
Queen's Hospital, Romford
NOT_YET_RECRUITING
Tunbridge Wells Hospital, Royal Tunbridge Wells
NOT_YET_RECRUITING
Salford Royal Hospital, Salford
NOT_YET_RECRUITING
Salisbury District Hospital, Salisbury
NOT_YET_RECRUITING
Scarborough General Hospital, Scarborough
NOT_YET_RECRUITING
Scunthorpe General Hospital, Scunthorpe
NOT_YET_RECRUITING
Royal Hallamshire Hospital, Sheffield
NOT_YET_RECRUITING
Royal Shrewsbury Hospital, Shrewsbury
NOT_YET_RECRUITING
Southampton General Hospital, Southampton
NOT_YET_RECRUITING
St Helens Hospital, St Helens
NOT_YET_RECRUITING
Stafford County Hospital, Stafford
NOT_YET_RECRUITING
Stepping Hill Hospital, Stockport
NOT_YET_RECRUITING
Royal Stoke University Hospital, Stoke-on-Trent
NOT_YET_RECRUITING
Sunderland Royal Hospital, Sunderland
NOT_YET_RECRUITING
Good Hope Hospital, Sutton Coldfield
NOT_YET_RECRUITING
Singleton Hospital, Swansea
NOT_YET_RECRUITING
St George's Hospital, Tooting
NOT_YET_RECRUITING
Torbay District General Hospital, Torquay
NOT_YET_RECRUITING
Royal Cornwall Hospital, Truro
NOT_YET_RECRUITING
Hillingdon Hospital, Uxbridge
NOT_YET_RECRUITING
Pinderfields General Hospital, Wakefield
NOT_YET_RECRUITING
Warwick Hospital, Warwick
NOT_YET_RECRUITING
Sandwell General Hospital, West Bromwich
NOT_YET_RECRUITING
Royal Albert Edward Infirmary, Wigan
NOT_YET_RECRUITING
Royal Hampshire County Hospital, Winchester
NOT_YET_RECRUITING
New Cross Hospital, Wolverhampton
NOT_YET_RECRUITING
Worcestershire Royal Hospital, Worcester
NOT_YET_RECRUITING
Worthing Hospital, Worthing
NOT_YET_RECRUITING
Wrexham Maelor Hospital, Wrexham
NOT_YET_RECRUITING
York Hospital, York
Collaborators (3)
Cancer Research UK
OTHER
Takeda
INDUSTRY
Celgene
INDUSTRY
University of Leeds
OTHER