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Looking for participantsPhase3

The Role of Ixazomib in Autologous Stem Cell Transplant in Relapsed Myeloma - Myeloma XII (ACCoRd)

Sponsor: University of Leeds

NCT ID: NCT03562169

View on ClinicalTrials.gov ↗

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).

Multiple Myeloma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

have a negative

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
Inclusion Criteria: 1. Diagnosed with relapsed MM (with measurable disease, according to IMWG criteria (Appendix 2)) previously treated with ASCT). 2. First Progressive Disease (PD) at least 12 months following first ASCT, requiring therapy. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Appendix 3). 4. Aged at least 18 years. 5. Participants must have the following blood results within 14 days before registration: 1. Absolute neutrophil count (ANC) ≥1x109/L 2. 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. 6. Adequate renal function within 14 days before registration: a. Creatinine clearance ≥30ml/min (calculated according to the Cockcroft-Gault equation or other locally approved formula) 7. Adequate hepatobiliary function within 14 days before registration: 1. Total bilirubin \<2 x upper limit of normal (ULN) 2. ALT \<2 x ULN 8. Adequate pulmonary function within 14 days before registration: a. 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. 9. Adequate cardiac function within 12 weeks before registration a. Left ventricular ejection fraction (LVEF) ≥40%. Note: repeat confirmation of cardiac function is needed if treatment is given between this assessment and registration. 10. Female participants who: 1. Are not of childbearing potential (Appendix 8), OR 2. 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 3. 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: 1. Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR 2. 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. 11. 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. 12. 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. 13. Able to provide written informed consent. Exclusion Criteria: 1. 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. 2. ≥Grade 2 peripheral neuropathy within 14 days before registration. 3. Known HIV seropositivity. 4. Known resistance, intolerance or sensitivity to any component of the planned therapies. 5. Any medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study. 6. 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). 7. Pregnant, lactating or breast feeding female participants. 8. Failure to have fully recovered (i.e.Grade 1 or less toxicity) from the reversible effects of prior chemotherapy. 9. Major surgery within 14 days before registration. 10. Central nervous system involvement with myeloma. 11. Ongoing or active infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration. 12. 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. 13. 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. 14. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, including difficulty swallowing. 15. Patients that have previously been treated with ixazomib or participated in a study with ixazomib whether treated with ixazomib or not. 16. Participant has current or prior hepatitis B or C infection.

Where Is This Study? (91 UK sites)

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Monklands Hospital

Airdrie, United Kingdom

Recruiting
Hospital R&D contact (matched)

Raymond Hamill

raymond.hamill@lanarkshire.scot.nhs.uk01236 712460

University Hospital Ayr

Ayr, United Kingdom

Recruiting

Barnsley Hospital

Barnsley, United Kingdom

Recruiting
Hospital R&D contact (matched)

RM&G Office

barnsley.research@nhs.net01226 432348

Basingstoke & North Hampshire Hospital

Basingstoke, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Manager

research.team@hhft.nhs.uk01256 473202 Ext 4557

Royal United Hospital

Bath, United Kingdom

Recruiting
Hospital R&D contact (matched)

Amy Lloyd

ruh-tr.researchgovernance@nhs.net01225 821669

Good Hope Hospital

Birmingham, United Kingdom

Recruiting

Heartlands Hospital

Birmingham, United Kingdom

Recruiting

Queen Elizabeth Hospital

Birmingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Blackpool Victoria Hospital

Blackpool, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Angela Parker

bfwh.randd.office@nhs.net01253 (9) 51514 / (9) 55547

Pilgrim Hospital

Boston, United Kingdom

Recruiting

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Bradford Royal Infirmary

Bradford, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jane Dennison

bradfordresearch.applications@bthft.nhs.uk01274 382575

Bristol Haematology & Oncology Centre

Bristol, United Kingdom

Recruiting

Southmead Hospital

Bristol, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Queen's Hospital

Burton-on-Trent, United Kingdom

Recruiting
Hospital R&D contact (matched)

Heidi Chandler

bhrut.development.research@nhs.net01708 435000 ex 2923

Addenbrooke's Hospital

Cambridge, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

St Helier Hospital

Carshalton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Please contact ESTH.Research@nhs.net

ESTH.Research@nhs.net0208 2964699

Cheltenham General Hospial

Cheltenham, United Kingdom

Recruiting

Countess of Chester Hospital

Chester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jude Prince

coch.rd-facilitator@nhs.net01244 365243

Chesterfield Royal Hospital

Chesterfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Spencer

CRHFT.Researchadmin@nhs.net01246 513632

St Richards Hospital

Chichester, United Kingdom

Recruiting

University Hospital Coventry

Coventry, United Kingdom

Recruiting
Hospital R&D contact (matched)

Josie Goodby

research@uhcw.nhs.uk02476 965244

Royal Derby Hospital

Derby, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Teresa Grieve

uhdb.researchgov@nhs.net01332 724639 / 01332 724638

Dewsbury Hospital

Dewsbury, United Kingdom

Recruiting

Russells Hall Hospital

Dudley, United Kingdom

Recruiting
Hospital R&D contact (matched)

Claire Phillips

dgft.research.rhh@nhs.net01384 456111

Ninewells Hospital

Dundee, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mrs Liz Coote

Liz.Coote@nhs.scot01382 383876

Hairmyres Hospital

East Kilbride, United Kingdom

Recruiting

Western General Hospital

Edinburgh, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Donna Noonan

gwh.researchmanagement@nhs.net01793 605565

Beatson Cancer Centre

Glasgow, United Kingdom

Recruiting

New Victoria Hospital

Glasgow, United Kingdom

Recruiting

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Professional Services

ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467

Grantham and District Hospital

Grantham, United Kingdom

Recruiting

Diana Princess of Wales Hospital

Grimsby, United Kingdom

Recruiting

Calderdale Royal Hospital

Halifax, United Kingdom

Recruiting

Harrogate District Hospital

Harrogate, United Kingdom

Recruiting
Hospital R&D contact (matched)

Michelle Platton

hdft.research@nhs.net01423 555692

Huddersfield Royal Infirmary

Huddersfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Castle Hill Hospital

Hull, United Kingdom

Recruiting
Hospital R&D contact (matched)

James Illingworth

hyp-tr.development.research@nhs.net01482 461883 or 461903

Raigmore Hospital

Inverness, United Kingdom

Recruiting

Ipswich Hospital

Ipswich, United Kingdom

Recruiting
Hospital R&D contact (matched)

Frances Farnworth

R&D@esneft.nhs.uk01473 704787

Kidderminster Hospital

Kidderminster, United Kingdom

Recruiting

University Hospital Crosshouse

Kilmarnock, United Kingdom

Recruiting

St James's University Hospital

Leeds, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Leicester Royal Infirmary

Leicester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Lincoln County Hospital

Lincoln, United Kingdom

Recruiting
Hospital R&D contact (matched)

Ms Hannah Finch

hannah.finch9@nhs.net01522 573941 ext 582059-

Royal Liverpool University Hospital

Liverpool, United Kingdom

Recruiting

University Hospital Aintree

Liverpool, United Kingdom

Recruiting
Hospital R&D contact (matched)

Michelle Mossa

research.development@aintree.nhs.uk0151 529 5870

Guys and St Thomas's Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Kings College Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

Royal Marsden Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

St Barts Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

University College London Hospital

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Maidstone Hospital

Maidstone, United Kingdom

Recruiting
Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

Manchester Royal Infirmary

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

The Christie

Manchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Borders General Hospital

Melrose, United Kingdom

Recruiting
Hospital R&D contact (matched)

Olga Balazikova

research@sabp.nhs.uk01372 216 584

James Cook University Hospital

Middlesbrough, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

stees.dtvra@nhs.net01642 854089

Milton Keynes General Hospital

Milton Keynes, United Kingdom

Recruiting
Hospital R&D contact (matched)

Antoanela Colda

Antoanela.colda@mkuh.nhs.uk01908 995119 / 01908 996651

Freeman Hospital

Newcastle, United Kingdom

Recruiting

North Tyneside General Hospital

North Shields, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Development

researchanddevelopment@nhct.nhs.uk0191 2934087

Norfolk & Norwich University Hospital

Norwich, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

Nottingham City Hospital

Nottingham, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Lloyd

nuhnt.researchsponsor@nhs.net0115 9249924

Royal Oldham Hospital

Oldham, United Kingdom

Recruiting

Churchill Hospital

Oxford, United Kingdom

Recruiting

Royal Alexandra Hospital

Paisley, United Kingdom

Recruiting

Derriford Hospital

Plymouth, United Kingdom

Recruiting

Pontefract Hospital

Pontefract, United Kingdom

Recruiting

Whiston Hospital

Prescot, United Kingdom

Recruiting

Royal Berkshire Hospital

Reading, United Kingdom

Recruiting
Hospital R&D contact (matched)

Leslie Frederick-Mokogwu

researchanddevelopment@royalberkshire.nhs.uk0118 322 7449

Redditch Hospital

Redditch, United Kingdom

Recruiting

Tunbridge Wells Hospital

Royal Tunbridge Wells, United Kingdom

Recruiting
Hospital R&D contact (matched)

Denise Day / Julie Knowles

mtw-tr.researchgovernance@nhs.net01622 225627

Salford Royal Hospital

Salford, United Kingdom

Recruiting

Salisbury Hospital

Salisbury, United Kingdom

Recruiting
Hospital R&D contact (matched)

Kate Ames

sft.sftresearch@nhs.net01722 336262

Scunthorpe General Hospital

Scunthorpe, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rachel Pollard (Governance Manager)

r.pollard@nhs.net03033 306366

Royal Hallamshire Hospital

Sheffield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alessia Dunn

STH.ResearchAdministration@nhs.net0114 2712550

Southampton General Hospital

Southampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

St Helens Hospital

St Helens, United Kingdom

Recruiting

Stafford County Hospital

Stafford, United Kingdom

Recruiting

Stepping Hill Hospital

Stockport, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research, Development & Innovation Office

research.development@stockport.nhs.uk0161 419 5893

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Jones

studysetup@uhnm.nhs.uk01782 675385

Sunderland Royal Hospital

Sunderland, United Kingdom

NOT_YET_RECRUITING

King's Mill Hospital

Sutton in Ashfield, United Kingdom

Recruiting
Hospital R&D contact (matched)

Alison Steel

sfh-tr.researchandinnovation@nhs.net01623 622515 ext 3990

Singleton Hospital

Swansea, United Kingdom

Recruiting

Musgrove Park Hospital

Taunton, United Kingdom

Recruiting

St George's Hospital

Tooting, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

Pinderfields General Hospital

Wakefield, United Kingdom

Recruiting

Royal Hampshire County Hospital

Winchester, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Manager

research.team@hhft.nhs.uk01256 473202 Ext 4557

Wishaw Hospital

Wishaw, United Kingdom

Recruiting

New Cross Hospital

Wolverhampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Glover

rwh-tr.rdpmteam@nhs.net01902 695065

Worcestershire Royal Hospital

Worcester, United Kingdom

Recruiting

Worthing Hospital

Worthing, United Kingdom

Recruiting
Hospital R&D contact (matched)

Scott Harfield

uhsussex.research@nhs.net01273 696955 ext. 67497

How to Get in Touch

Gwen Jacques, Senior Trial Coordinator

Sponsor contact

CONTACT

0044 113 343 1159 ctru-myelomaxii@leeds.ac.uk

Trial Management Assistant

Sponsor contact

CONTACT

0044 113 343 5476 ctru-myelomaxii@leeds.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2018-05