Taking people in United KingdomPhase 3

Tests ixazomib with stem cell transplant in relapsed myeloma

Tests ixazomib added to stem cell transplant in adults with relapsed myeloma.

Plain-language title generated from the registry record
Registry title: The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)

Key facts

Where: Aberdeen, Airdrie, Ayr, Barnsley, Basingstoke, Bath, Birmingham, Blackpool, Boston, Bournemouth, Bradford, Bristol, Burton-on-Trent, Cambridge, Carshalton, Cheltenham, Chester, Chesterfield, Chichester, Coventry, Derby, Dewsbury, Dudley, Dundee, East Kilbride, Edinburgh, Glasgow, Gloucester, Grantham, Grimsby, Halifax, Harrogate, Huddersfield, Hull, Inverness, Ipswich, Kidderminster, Kilmarnock, Leeds, Leicester, Lincoln, Liverpool, London, Maidstone, Manchester, Melrose, Middlesbrough, Milton Keynes, Newcastle, North Shields, Norwich, Nottingham, Oldham, Oxford, Paisley, Plymouth, Pontefract, Prescot, Reading, Redditch, Royal Tunbridge Wells, Salford, Salisbury, Scunthorpe, Sheffield, Southampton, St Helens, Stafford, Stockport, Stoke-on-Trent, Sunderland, Sutton in Ashfield, Swansea, Taunton, Tooting, Wakefield, Winchester, Wishaw, Wolverhampton, Worcester, and Worthing, United KingdomSee the 91 sites
Phase: Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose multiple myeloma has come back at least 12 months after a first stem cell transplant and needs treatment.

Age: At least 18 years old.
Sex: All sexes can join.
Disease stage: Relapsed multiple myeloma with measurable disease, first progression at least 12 months after the first stem cell transplant, needing therapy. ECOG performance status 0-2.
Earlier treatment: Must have had a stem cell transplant (ASCT) before. Must not have had other second-line treatment for this relapse, apart from local radiotherapy, plasma exchange, or limited dexamethasone. Must not have had ixazomib before.

Main reasons for not taking part

Grade 2 or worse peripheral neuropathy
Known HIV, or current or past hepatitis B or C infection
Other cancers in the past or now (a few skin and in situ cancers are allowed)
Myeloma in the central nervous system
Pregnant or breastfeeding women

Read by machine on 12 November 2026.

Where in United Kingdom

Aberdeen Royal InfirmaryAberdeen, United KingdomContact: Jane TigheTaking people
Monklands HospitalAirdrie, United KingdomContact: Iain SingerTaking people
University Hospital AyrAyr, United KingdomContact: Paul Micallef-EynaudTaking people
Barnsley HospitalBarnsley, United KingdomContact: Youssef SorourTaking people
Basingstoke & North Hampshire HospitalBasingstoke, United KingdomContact: Noel RymanTaking people
Royal United HospitalBath, United KingdomContact: Sally MooreTaking people
Good Hope HospitalBirmingham, United KingdomContact: Anand LokareTaking people
Heartlands HospitalBirmingham, United KingdomContact: Anand LokareTaking people
Queen Elizabeth HospitalBirmingham, United KingdomContact: Mark CookTaking people
Blackpool Victoria HospitalBlackpool, United KingdomContact: Mark GreyTaking people
Pilgrim HospitalBoston, United KingdomContact: Charlotte KallmeyerTaking people
Royal Bournemouth HospitalBournemouth, United KingdomContact: Rachel HallTaking people
Bradford Royal InfirmaryBradford, United KingdomContact: Anshu GargTaking people
Bristol Haematology & Oncology CentreBristol, United KingdomContact: James GriffinTaking people
Southmead HospitalBristol, United KingdomContact: Alistair WhitewayTaking people
Queen's HospitalBurton-on-Trent, United KingdomContact: Humayun AhmadTaking people
Addenbrooke's HospitalCambridge, United KingdomContact: Charles CrawleyTaking people
St Helier HospitalCarshalton, United KingdomContact: Simon SternTaking people
Cheltenham General HospialCheltenham, United KingdomContact: Michael ShieldsTaking people
Countess of Chester HospitalChester, United KingdomContact: Salah TuegerTaking people
Chesterfield Royal HospitalChesterfield, United KingdomContact: Rowena FaulknerTaking people
St Richards HospitalChichester, United KingdomContact: Jamie WilsonTaking people
University Hospital CoventryCoventry, United KingdomContact: Beth HarrisonTaking people
Royal Derby HospitalDerby, United KingdomContact: David AlloteyTaking people
Dewsbury HospitalDewsbury, United KingdomContact: John AshcroftTaking people
Russells Hall HospitalDudley, United KingdomContact: Rupert HipkinsTaking people
Ninewells HospitalDundee, United KingdomContact: Duncan GowansTaking people
Hairmyres HospitalEast Kilbride, United KingdomContact: Iain SingerTaking people
Western General HospitalEdinburgh, United KingdomContact: Huw RoddieTaking people
Beatson Cancer CentreGlasgow, United KingdomContact: Grant McQuakerTaking people
New Victoria HospitalGlasgow, United KingdomContact: Ian MacDonaldTaking people
Gloucestershire Royal HospitalGloucester, United KingdomContact: Michael ShieldsTaking people
Grantham and District HospitalGrantham, United KingdomContact: Charlotte KallmeyerTaking people
Diana Princess of Wales HospitalGrimsby, United KingdomContact: Sanjeev JalihalTaking people
Calderdale Royal HospitalHalifax, United KingdomContact: Sylvia FeylerTaking people
Harrogate District HospitalHarrogate, United KingdomContact: Tharani BalasubramaniamTaking people
Huddersfield Royal InfirmaryHuddersfield, United KingdomContact: Sylvia FeylerTaking people
Castle Hill HospitalHull, United KingdomContact: Senthilkumar DurairajTaking people
Raigmore HospitalInverness, United KingdomContact: Peter ForsythTaking people
Ipswich HospitalIpswich, United KingdomContact: Debo AdemokunTaking people
Kidderminster HospitalKidderminster, United KingdomContact: Saleem ShafikTaking people
University Hospital CrosshouseKilmarnock, United KingdomContact: Paul Micallef-EynaudTaking people
St James's University HospitalLeeds, United KingdomContact: Gordon CookTaking people
Leicester Royal InfirmaryLeicester, United KingdomContact: Mamta GargTaking people
Lincoln County HospitalLincoln, United KingdomContact: Charlotte KallmeyerTaking people
Royal Liverpool University HospitalLiverpool, United KingdomContact: Stephen HawkinsTaking people
University Hospital AintreeLiverpool, United KingdomContact: Lynny YoungTaking people
Guys and St Thomas's HospitalLondon, United KingdomContact: Majid KazmiTaking people
Kings College HospitalLondon, United KingdomContact: Majid KazmiTaking people
Royal Marsden HospitalLondon, United KingdomContact: Kevin BoydTaking people
St Barts HospitalLondon, United KingdomContact: Jamie CavenaghTaking people
University College London HospitalLondon, United KingdomContact: Kwee YongTaking people
Maidstone HospitalMaidstone, United KingdomContact: Lolita BanerjeeTaking people
Manchester Royal InfirmaryManchester, United KingdomContact: Alberto RocciTaking people
The ChristieManchester, United KingdomContact: Samar KulkarniTaking people
Borders General HospitalMelrose, United KingdomContact: Jennifer BuxtonTaking people
James Cook University HospitalMiddlesbrough, United KingdomContact: Marianna DavidTaking people
Milton Keynes General HospitalMilton Keynes, United KingdomContact: Moez DungarwallaTaking people
Freeman HospitalNewcastle, United KingdomContact: Graham JacksonTaking people
North Tyneside General HospitalNorth Shields, United KingdomContact: Mari KilnerTaking people
Norfolk & Norwich University HospitalNorwich, United KingdomContact: Kristian BowlesTaking people
Nottingham City HospitalNottingham, United KingdomContact: Jenny ByrneTaking people
Royal Oldham HospitalOldham, United KingdomContact: Hayley GreenfieldTaking people
Churchill HospitalOxford, United KingdomContact: Jam KothariTaking people
Royal Alexandra HospitalPaisley, United KingdomContact: Alison SefcickTaking people
Derriford HospitalPlymouth, United KingdomContact: Hannah HunterTaking people
Pontefract HospitalPontefract, United KingdomContact: John AshcroftTaking people
Whiston HospitalPrescot, United KingdomContact: Toby NicholsonTaking people
Royal Berkshire HospitalReading, United KingdomContact: Henri GrechTaking people
Redditch HospitalRedditch, United KingdomContact: Saleem ShafikTaking people
Tunbridge Wells HospitalRoyal Tunbridge Wells, United KingdomContact: Lolita BanerjeeTaking people
Salford Royal HospitalSalford, United KingdomContact: Sonya RavenscroftTaking people
Salisbury HospitalSalisbury, United KingdomContact: Jonathan CullisTaking people
Scunthorpe General HospitalScunthorpe, United KingdomContact: Sanjeev JalihalTaking people
Royal Hallamshire HospitalSheffield, United KingdomContact: John SnowdenTaking people
Southampton General HospitalSouthampton, United KingdomContact: Matthew JennerTaking people
St Helens HospitalSt Helens, United KingdomContact: Toby NicholsonTaking people
Stafford County HospitalStafford, United KingdomContact: Kamaraj KarunanithiTaking people
Stepping Hill HospitalStockport, United KingdomContact: Montaser HajTaking people
Royal Stoke University HospitalStoke-on-Trent, United KingdomContact: Kamaraj KarunanithiTaking people
Sunderland Royal HospitalSunderland, United KingdomContact: Victoria HerveyNot yet recruiting
King's Mill HospitalSutton in Ashfield, United KingdomContact: Tim MoorbyTaking people
Singleton HospitalSwansea, United KingdomContact: Hamdi SatiTaking people
Musgrove Park HospitalTaunton, United KingdomContact: Simon BolamTaking people
St George'S HospitalTooting, United KingdomContact: Fenella WillisTaking people
Pinderfields General HospitalWakefield, United KingdomContact: John AshcroftTaking people
Royal Hampshire County HospitalWinchester, United KingdomContact: Noel RymanTaking people
Wishaw HospitalWishaw, United KingdomContact: Iain SingerTaking people
New Cross HospitalWolverhampton, United KingdomContact: Supratik BasuTaking people
Worcestershire Royal HospitalWorcester, United KingdomContact: Saleem ShafikTaking people
Worthing HospitalWorthing, United KingdomContact: Jamie WilsonTaking people

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: University of Leeds
Trial code: NCT03562169
Record updated: 19 June 2018
Original description: Study design: Randomised, controlled, multi-centre, open-label, phase III trial (with a single intervention registration phase).Read full original descriptionShow less
A Phase III Study to Determine the Role of Ixazomib as an Augmented Conditioning Therapy in Salvage Autologous Stem Cell Transplant (ASCT) and as a Post-ASCT Consolidation and Maintenance Strategy in Patients With Relapsed Multiple Myeloma
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).
Inclusion: Diagnosed with relapsed MM (with measurable disease, according to IMWG criteria (Appendix 2)) previously treated with ASCT); First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy; Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 3); Aged at least 18 years; Participants must have the following blood results within 14 days before registration:; Absolute neutrophil count (ANC) ≥1x109/L; Platelet count ≥75x109/L. If the participant has ≥50% bone marrow infiltration a platelet count of ≥50x109/L is allowed; Platelet transfusions are not allowed within 3 days before registration in order to meet these values; Adequate renal function within 14 days before registration:; Creatinine clearance ≥30ml/min (calculated according to the Cockcroft-Gault equation or other locally approved formula); Adequate hepatobiliary function within 14 days before registration:; Total bilirubin <2 x upper limit of normal (ULN); ALT <2 x ULN; Adequate pulmonary function within 14 days before registration:; Adequate respiratory functional reserve (delineated by KCO/DLCO (carbon monoxide diffusion in the lung) of ≥50%). No evidence of a history of pulmonary disease. If a significant history, then a review by a respiratory medicine physician is required; Adequate cardiac function within 12 weeks before registration; Left ventricular ejection fraction (LVEF) ≥40%. Note: repeat confirmation of cardiac function is needed if treatment is given between this assessment and registration; Female participants who:; Are not of childbearing potential (Appendix 8), OR; If they are of childbearing potential (Appendix 8), agree to practice 2 effective methods of contraception (Appendix 8), at the same time, from the time of signing the informed consent form until 90 days after the last dose of study drug, OR; Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.); Male participants, even if surgically sterilised (i.e. status post-vasectomy), must agree to one of the following:; Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR; Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.) Contraception for female and male participants must be in accordance with (and consent to) the Celgene-approved Thalidomide Pregnancy Prevention Programme; If female and of childbearing potential (see Appendix 8), must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene Thalidomide Pregnancy Prevention Programme; Patients agree not to receive other clinical trials treatment, including investigational medicinal products (IMPs) not included in this trial, within 30 days of trial registration and throughout the duration of the trial, until disease progression; Able to provide written informed consent.
Exclusion: Received prior second line therapy for their relapsed disease other than local radiotherapy, therapeutic plasma exchange, or dexamethasone (up to a maximum of 200mg is allowed but not within 30 days prior to registration). Radiotherapy sufficient to alleviate or control pain of local invasion is permitted, but must not be within 14 days before registration. Patients who have received hemi-body radiation or similar since relapse will not be eligible; ≥Grade 2 peripheral neuropathy within 14 days before registration; Known resistance, intolerance or sensitivity to any component of the planned therapies; Previous or concurrent malignancies at other sites (excluding completely resected non-melanoma skin cancer or carcinoma in situ of any type, such as cervical cancer); Failure to have fully recovered (i.e.Grade 1 or less toxicity) from the reversible effects of prior chemotherapy; Major surgery within 14 days before registration; Ongoing or active infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration; Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort; Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not; Participant has current or prior hepatitis B or C infection; Known HIV seropositivity; Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study; Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months; Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, including difficulty swallowing; Pregnant, lactating or breast feeding female participants; Central nervous system involvement with myeloma.
ClinicalTrials.gov NCT03562169