At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ixazomib, thalidomide, & dexamethasone (ITD) re-induction (drug), Conventional autologous stem cell transplant (ASCT-con) (drug), Augmented autologous stem cell transplant (ASCT-aug) (drug), ITD consolidation and ixazomib maintenance vs. No further therapy (drug)
- How long the study runs
- Study runs about 120 months (dates as stated)
- About the drug or intervention
- Ixazomib, thalidomide, & dexamethasone (ITD) re-induction — drug: 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) — drug: Melphalan 200mg/m2 IV infusion on Day -1, followed by ASCT on Day 0. · Augmented autologous stem cell transplant (ASCT-aug) — drug: Melphalan 100mg/m2 IV infusion on Day -3 and Day -2 plus ixazomib 4mg capsules on Day -4 and Day -1. · ITD consolidation and ixazomib maintenance vs. No further therapy — drug: Participants will be randomised to either 'no further therapy' or 'ITD consolidation and ixazomib maintenance'.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 406
- Started
- 2017-03-20
- Last checked
- 2018-05
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase3 - 406 participants
- • Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Aberdeen - Aberdeen Royal Infirmary
- • Airdrie - Monklands Hospital
- • Ayr - University Hospital Ayr
- • Barnsley - Barnsley Hospital
- • +87 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase). Primary Objectives The primary objectives of this study are to determine: * The impact on Depth of Response (DoR: less than VGPR versus VGPR or better) when salvage ASCT conditioning is augmented by the addition of a proteasome inhibitor * The influence of a consolidation and maintenance strategy on the Durability of Response (DuR:PFS) Secondary objectives The secondary objectives of this study are to determine: * Overall survival * Time to disease progression * The overall response rate following ixazomib, thalidomide and dexamethasone (ITD) re-induction * Time to next treatment * Progression-free survival 2 (PFS2) * Duration of response * Minimal Residual Disease (MRD) negative rate post re-induction, post-ASCT and conversion after ITD consolidation * Engraftment kinetics * Toxicity and safety * Quality of life (QoL) Participant population (refer to protocol section 9 for a full list of eligibility criteria). * Relapsed MM (with measurable disease by IMWG criteria) previously treated with ASCT * First progressive disease (PD) at least 12 months since first ASCT, requiring therapy. * ECOG Performance Status 0-2 * Aged at least 18 years * Adequate full blood count and renal, hepatobiliary, pulmonary and cardiac function * Written informed consent Interventions: All participants will be registered at trial entry and will receive re-induction therapy with 4-6, 28-day cycles of ixazomib, thalidomide and dexamethasone (ITD), in order to reach maximum response. Participants who achieve at least stable disease (SD) will be randomised on a 1:1 basis to receive either conventional ASCT (ASCTCon), using melphalan, or augmented ASCT (ASCTAug), using melphalan with ixazomib. All participants achieving or maintaining a minimal response (MR) or better following trial ASCT will undergo a second randomisation to consolidation and maintenance or no further treatment. Participants randomised to consolidation and maintenance will receive treatment as follows: consolidation with 2 cycles of ITD and maintenance with ixazomib until disease progression. Number of participants: 406 participants will be registered into the trial to allow 284 participants to be randomised at the first randomisation (R1) and 248 participants to be randomised at the second randomisation (R2).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ the following blood results within 14 days
What the study is looking for
- ✓Diagnosed with relapsed MM (with cancer that can be measured on scans, according to IMWG criteria (Appendix 2)) previously treated...
- ✓First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy.
- ✓activity scale (ECOG) Performance Status 0-2 (Appendix 3).
- ✓Aged at least 18 years.
- ✓Participants must have the following blood results within 14 days before registration:
Who cannot take part
- ✗≥Grade 2 peripheral neuropathy within 14 days before registration.
- ✗Known HIV seropositivity.
- ✗Known resistance, intolerance or sensitivity to any component of the planned therapies.
- ✗Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's...
- ✗Previous or concurrent malignancies at other sites (excluding completely resected non-melanoma skin cancer or...
See the full criteria
Where Is This Study? (91 UK sites)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Monklands Hospital
Airdrie, United Kingdom
University Hospital Ayr
Ayr, United Kingdom
Barnsley Hospital
Barnsley, United Kingdom
Basingstoke & North Hampshire Hospital
Basingstoke, United Kingdom
Royal United Hospital
Bath, United Kingdom
Good Hope Hospital
Birmingham, United Kingdom
Heartlands Hospital
Birmingham, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Pilgrim Hospital
Boston, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Research Development & Support
clinicalresearch@bournemouth.ac.uk01202 961200Bradford Royal Infirmary
Bradford, United Kingdom
Bristol Haematology & Oncology Centre
Bristol, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Queen's Hospital
Burton-on-Trent, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
St Helier Hospital
Carshalton, United Kingdom
Cheltenham General Hospial
Cheltenham, United Kingdom
Countess of Chester Hospital
Chester, United Kingdom
Chesterfield Royal Hospital
Chesterfield, United Kingdom
St Richards Hospital
Chichester, United Kingdom
University Hospital Coventry
Coventry, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Dewsbury Hospital
Dewsbury, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Hairmyres Hospital
East Kilbride, United Kingdom
Western General Hospital
Edinburgh, United Kingdom
Beatson Cancer Centre
Glasgow, United Kingdom
New Victoria Hospital
Glasgow, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Grantham and District Hospital
Grantham, United Kingdom
Diana Princess of Wales Hospital
Grimsby, United Kingdom
Calderdale Royal Hospital
Halifax, United Kingdom
Harrogate District Hospital
Harrogate, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Castle Hill Hospital
Hull, United Kingdom
James Illingworth
hyp-tr.development.research@nhs.net01482 461883 or 461903Raigmore Hospital
Inverness, United Kingdom
Ipswich Hospital
Ipswich, United Kingdom
Kidderminster Hospital
Kidderminster, United Kingdom
University Hospital Crosshouse
Kilmarnock, United Kingdom
St James's University Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351Lincoln County Hospital
Lincoln, United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom
University Hospital Aintree
Liverpool, United Kingdom
Guys and St Thomas's Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
St Barts Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Maidstone Hospital
Maidstone, United Kingdom
Denise Day / Julie Knowles
mtw-tr.researchgovernance@nhs.net01622 225627Manchester Royal Infirmary
Manchester, United Kingdom
The Christie
Manchester, United Kingdom
Borders General Hospital
Melrose, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Milton Keynes General Hospital
Milton Keynes, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
North Tyneside General Hospital
North Shields, United Kingdom
Research and Development
researchanddevelopment@nhct.nhs.uk0191 2934087Norfolk & Norwich University Hospital
Norwich, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Royal Oldham Hospital
Oldham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Royal Alexandra Hospital
Paisley, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Pontefract Hospital
Pontefract, United Kingdom
Whiston Hospital
Prescot, United Kingdom
Royal Berkshire Hospital
Reading, United Kingdom
Leslie Frederick-Mokogwu
researchanddevelopment@royalberkshire.nhs.uk0118 322 7449Redditch Hospital
Redditch, United Kingdom
Tunbridge Wells Hospital
Royal Tunbridge Wells, United Kingdom
Denise Day / Julie Knowles
mtw-tr.researchgovernance@nhs.net01622 225627Salford Royal Hospital
Salford, United Kingdom
Salisbury Hospital
Salisbury, United Kingdom
Scunthorpe General Hospital
Scunthorpe, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
St Helens Hospital
St Helens, United Kingdom
Stafford County Hospital
Stafford, United Kingdom
Stepping Hill Hospital
Stockport, United Kingdom
Research, Development & Innovation Office
research.development@stockport.nhs.uk0161 419 5893Royal Stoke University Hospital
Stoke-on-Trent, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom
King's Mill Hospital
Sutton in Ashfield, United Kingdom
Singleton Hospital
Swansea, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom
St George's Hospital
Tooting, United Kingdom
Pinderfields General Hospital
Wakefield, United Kingdom
Royal Hampshire County Hospital
Winchester, United Kingdom
Wishaw Hospital
Wishaw, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Worcestershire Royal Hospital
Worcester, United Kingdom
Worthing Hospital
Worthing, United Kingdom
How to Get in Touch
Gwen Jacques, Senior Trial Coordinator
Sponsor contactCONTACT
Trial Management Assistant
Sponsor contactCONTACT
