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Multiple MyelomaPhase 3NCT03562169

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

A Phase 3 study testing Ixazomib, thalidomide, & dexamethasone (ITD) re-induction, Conventional autologous stem cell transplant (ASCT-con) and Augmented autologous stem cell transplant (ASCT-aug) in people with Multiple Myeloma, run by University of Leeds at 91 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Ixazomib, thalidomide, & dexamethasone (ITD) re-induction, Conventional autologous stem cell transplant (ASCT-con) and Augmented autologous stem cell transplant (ASCT-aug)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
406 participants
Where
91 sitesUnited Kingdom
Study dates
20 Mar 2017to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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 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 participation in this study.
  • 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).
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  • Pregnant, lactating or breast feeding female participants.
  • 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.
  • Central nervous system involvement with myeloma.
  • Ongoing or active infection requiring systemic antibiotic therapy or other serious infection within 14 days before registration.
  • 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.
  • 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.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib, including difficulty swallowing.
  • 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.

Trial locations and contacts

91 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Gwen Jacques, Senior Trial Coordinator contact

0044 113 343 1159

ctru-myelomaxii@leeds.ac.uk

Trial Management Assistant contact

0044 113 343 5476

ctru-myelomaxii@leeds.ac.uk

91 sites in 1 country

United Kingdom91 sites, 91 recruiting

  • Aberdeen Royal Infirmary

    Aberdeen

    Jane Tighe

    Recruiting

  • Monklands Hospital

    Airdrie

    Iain Singer

    Recruiting

  • University Hospital Ayr

    Ayr

    Paul Micallef-Eynaud

    Recruiting

  • Barnsley Hospital

    Barnsley

    Youssef Sorour

    Recruiting

  • Basingstoke & North Hampshire Hospital

    Basingstoke

    Noel Ryman

    Recruiting

  • Royal United Hospital

    Bath

    Sally Moore

    Recruiting

  • Good Hope Hospital

    Birmingham

    Anand Lokare

    Recruiting

  • Heartlands Hospital

    Birmingham

    Anand Lokare

    Recruiting

  • Queen Elizabeth Hospital

    Birmingham

    Mark Cook

    Recruiting

  • Blackpool Victoria Hospital

    Blackpool

    Mark Grey

    Recruiting

  • Pilgrim Hospital

    Boston

    Charlotte Kallmeyer

    Recruiting

  • Royal Bournemouth Hospital

    Bournemouth

    Rachel Hall

    Recruiting

  • Bradford Royal Infirmary

    Bradford

    Anshu Garg

    Recruiting

  • Bristol Haematology & Oncology Centre

    Bristol

    James Griffin

    Recruiting

  • Southmead Hospital

    Bristol

    Alistair Whiteway

    Recruiting

  • Queen's Hospital

    Burton-on-Trent

    Humayun Ahmad

    Recruiting

  • Addenbrooke's Hospital

    Cambridge

    Charles Crawley

    Recruiting

  • St Helier Hospital

    Carshalton

    Simon Stern

    Recruiting

  • Cheltenham General Hospial

    Cheltenham

    Michael Shields

    Recruiting

  • Countess of Chester Hospital

    Chester

    Salah Tueger

    Recruiting

  • Chesterfield Royal Hospital

    Chesterfield

    Rowena Faulkner

    Recruiting

  • St Richards Hospital

    Chichester

    Jamie Wilson

    Recruiting

  • University Hospital Coventry

    Coventry

    Beth Harrison

    Recruiting

  • Royal Derby Hospital

    Derby

    David Allotey

    Recruiting

  • Dewsbury Hospital

    Dewsbury

    John Ashcroft

    Recruiting

  • Russells Hall Hospital

    Dudley

    Rupert Hipkins

    Recruiting

  • Ninewells Hospital

    Dundee

    Duncan Gowans

    Recruiting

  • Hairmyres Hospital

    East Kilbride

    Iain Singer

    Recruiting

  • Western General Hospital

    Edinburgh

    Huw Roddie

    Recruiting

  • Beatson Cancer Centre

    Glasgow

    Grant McQuaker

    Recruiting

  • New Victoria Hospital

    Glasgow

    Ian MacDonald

    Recruiting

  • Gloucestershire Royal Hospital

    Gloucester

    Michael Shields

    Recruiting

  • Grantham and District Hospital

    Grantham

    Charlotte Kallmeyer

    Recruiting

  • Diana Princess of Wales Hospital

    Grimsby

    Sanjeev Jalihal

    Recruiting

  • Calderdale Royal Hospital

    Halifax

    Sylvia Feyler

    Recruiting

  • Harrogate District Hospital

    Harrogate

    Tharani Balasubramaniam

    Recruiting

  • Huddersfield Royal Infirmary

    Huddersfield

    Sylvia Feyler

    Recruiting

  • Castle Hill Hospital

    Hull

    Senthilkumar Durairaj

    Recruiting

  • Raigmore Hospital

    Inverness

    Peter Forsyth

    Recruiting

  • Ipswich Hospital

    Ipswich

    Debo Ademokun

    Recruiting

  • Kidderminster Hospital

    Kidderminster

    Saleem Shafik

    Recruiting

  • University Hospital Crosshouse

    Kilmarnock

    Paul Micallef-Eynaud

    Recruiting

  • St James's University Hospital

    Leeds

    Gordon Cook

    Recruiting

  • Leicester Royal Infirmary

    Leicester

    Mamta Garg

    Recruiting

  • Lincoln County Hospital

    Lincoln

    Charlotte Kallmeyer

    Recruiting

  • Royal Liverpool University Hospital

    Liverpool

    Stephen Hawkins

    Recruiting

  • University Hospital Aintree

    Liverpool

    Lynny Young

    Recruiting

  • Guys and St Thomas's Hospital

    London

    Majid Kazmi

    Recruiting

  • Kings College Hospital

    London

    Majid Kazmi

    Recruiting

  • Royal Marsden Hospital

    London

    Kevin Boyd

    Recruiting

  • St Barts Hospital

    London

    Jamie Cavenagh

    Recruiting

  • University College London Hospital

    London

    Kwee Yong

    Recruiting

  • Maidstone Hospital

    Maidstone

    Lolita Banerjee

    Recruiting

  • Manchester Royal Infirmary

    Manchester

    Alberto Rocci

    Recruiting

  • The Christie

    Manchester

    Samar Kulkarni

    Recruiting

  • Borders General Hospital

    Melrose

    Jennifer Buxton

    Recruiting

  • James Cook University Hospital

    Middlesbrough

    Marianna David

    Recruiting

  • Milton Keynes General Hospital

    Milton Keynes

    Moez Dungarwalla

    Recruiting

  • Freeman Hospital

    Newcastle

    Graham Jackson

    Recruiting

  • North Tyneside General Hospital

    North Shields

    Mari Kilner

    Recruiting

  • Norfolk & Norwich University Hospital

    Norwich

    Kristian Bowles

    Recruiting

  • Nottingham City Hospital

    Nottingham

    Jenny Byrne

    Recruiting

  • Royal Oldham Hospital

    Oldham

    Hayley Greenfield

    Recruiting

  • Churchill Hospital

    Oxford

    Jam Kothari

    Recruiting

  • Royal Alexandra Hospital

    Paisley

    Alison Sefcick

    Recruiting

  • Derriford Hospital

    Plymouth

    Hannah Hunter

    Recruiting

  • Pontefract Hospital

    Pontefract

    John Ashcroft

    Recruiting

  • Whiston Hospital

    Prescot

    Toby Nicholson

    Recruiting

  • Royal Berkshire Hospital

    Reading

    Henri Grech

    Recruiting

  • Redditch Hospital

    Redditch

    Saleem Shafik

    Recruiting

  • Tunbridge Wells Hospital

    Royal Tunbridge Wells

    Lolita Banerjee

    Recruiting

  • Salford Royal Hospital

    Salford

    Sonya Ravenscroft

    Recruiting

  • Salisbury Hospital

    Salisbury

    Jonathan Cullis

    Recruiting

  • Scunthorpe General Hospital

    Scunthorpe

    Sanjeev Jalihal

    Recruiting

  • Royal Hallamshire Hospital

    Sheffield

    John Snowden

    Recruiting

  • Southampton General Hospital

    Southampton

    Matthew Jenner

    Recruiting

  • St Helens Hospital

    St Helens

    Toby Nicholson

    Recruiting

  • Stafford County Hospital

    Stafford

    Kamaraj Karunanithi

    Recruiting

  • Stepping Hill Hospital

    Stockport

    Montaser Haj

    Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent

    Kamaraj Karunanithi

    Recruiting

  • Sunderland Royal Hospital

    Sunderland

    Victoria Hervey

    Not yet recruiting

  • King's Mill Hospital

    Sutton in Ashfield

    Tim Moorby

    Recruiting

  • Singleton Hospital

    Swansea

    Hamdi Sati

    Recruiting

  • Musgrove Park Hospital

    Taunton

    Simon Bolam

    Recruiting

  • St George's Hospital

    Tooting

    Fenella Willis

    Recruiting

  • Pinderfields General Hospital

    Wakefield

    John Ashcroft

    Recruiting

  • Royal Hampshire County Hospital

    Winchester

    Noel Ryman

    Recruiting

  • Wishaw Hospital

    Wishaw

    Iain Singer

    Recruiting

  • New Cross Hospital

    Wolverhampton

    Supratik Basu

    Recruiting

  • Worcestershire Royal Hospital

    Worcester

    Saleem Shafik

    Recruiting

  • Worthing Hospital

    Worthing

    Jamie Wilson

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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

Read more

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).

Being tested
Ixazomib, thalidomide, & dexamethasone (ITD) re-induction, Conventional autologous stem cell transplant (ASCT-con), Augmented autologous stem cell transplant (ASCT-aug), ITD consolidation and ixazomib maintenance vs. No further therapy
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ixazomib, thalidomide, & dexamethasone (ITD) re-inductionDrug

    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. ASCT will then be given on Day 0.

  • ITD consolidation and ixazomib maintenance vs. No further therapyDrug

    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.

Study groups in NCT03562169
Study groupRoleWhat they receive
Conventional Autologous Stem Cell Transplant (ASCT)Active comparatorMelphalan 200mg/m2 IV infusion on Day -1, followed by ASCT on Day 0
Receives: Drug: Ixazomib, thalidomide, & dexamethasone (ITD) re-induction; Drug: Conventional autologous stem cell transplant (ASCT-con); Drug: ITD consolidation and ixazomib maintenance vs. No further therapy
Augmented Autologous Stem Cell Transplant (ASCT)ExperimentalMelphalan 100mg/m2 IV infusion on Day -3 and -2 plus ixazomib 4mg capsules on Day -4 and -1. ASCT will then be given on Day 0.
Receives: Drug: Ixazomib, thalidomide, & dexamethasone (ITD) re-induction; Drug: Augmented autologous stem cell transplant (ASCT-aug); Drug: ITD consolidation and ixazomib maintenance vs. No further therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Overall response rate following ASCT will be determined according to the IMWG Uniform Response Criteria for Multiple Myeloma. This endpoint will be defined as a binary dichotomization of response (≥VGPR vs <VGPR) at an assessment 100 days after the date of stem cell transplant.

    Measured: 100 days post-ASCT

  2. Progression-free survival

    The influence of a consolidation and maintenance strategy on the Durability of Response (DuR: PFS)

    Measured: From date of registration to date of disease progression, up to 120 months.

Secondary outcomes (14)

  1. Overall survival

    Overall survival is defined as the time from randomisation to the consolidation/maintenance part of the trial post-ASCT to death from any cause or last follow-up.

    Measured: From date of R2 to date of death, up to 120 months

  2. Time to disease progression

    Time to disease progression is defined as time from randomisation to the consolidation/maintenance part of the trial post-ASCT to first documented evidence of disease progression. Participants who die without disease progression will be censored in the analysis.

    Measured: From date of registration until date of disease progression, up to 120 months

  3. Overall response rate to ITD re-induction

    Overall response rate following re-induction will be determined according to the IMWG Uniform Response Criteria for Multiple Myeloma.

    Measured: At the end of re-induction - after 4-6 re-induction cycles (each cycle is 28 days)

  4. Upgrade in response after two cycles of ITD consolidation

    Upgrade in response after 2 cycles of ITD consolidation - response rate following ITD consolidation will be determined according to the IMWG Uniform Response Criteria for Multiple Myeloma. This endpoint will be defined as a binary dichotomization of response (≥VGPR vs <VGPR).

    Measured: After 2 cycles of ITD consolidation (each cycle is 28 days)

  5. Progression-free survival 2 (PFS2)

    Progression-free survival 2 is defined as the time from second randomisation to the consolidation/maintenance part of the trial post-ASCT to second documented disease progression (or the start of next line anti-myeloma treatment), or death from any cause, whichever occurs first. Participants alive and for whom a second progression after second randomisation has not been observed will be censored at the last day they were known to be alive and second progression-free.

    Measured: Date of R2 to date of second disease progression, up to 120 months

  6. Time to next treatment

    Time to next line treatment is defined as the time from the date of randomisation to the date of commencement of next line treatment. Participants who do not receive next line treatment will be censored at the date of the last assessment or follow-up visit where they are known to have received no new therapy.

    Measured: Date of registration to start date of new therapy, up to 120 months

  7. Duration of response

    Duration of response to protocol treatment is defined from the time of achieving at least a partial response to the date of first documented evidence of disease progression. Participants who die prior to documentation of disease progression will be censored at the date of death. Participants dying from causes not primarily due to progression will also be censored at the date of death. Participants not reaching disease progression at the time of analysis will be censored at the last date known to be progression-free.

    Measured: Date of achieving at least partial response to date of disease progression, up to 120 months

  8. Proportion of patients Minimal Residual Disease negative

    Proportion of patients Minimal Residual Disease negative is defined as the proportion of participants with minimal residual disease (MRD) negative as assessed by flow cytometry will be assessed at various points in trial protocol treatment.

    Measured: Baseline; End of re-induction (after 4-6 cycles of re-induction, each cycle is 28 days); 100 days post-ASCT; After 2 cycles of consolidation (each cycle is 28 days); 8 weeks post-randomisation 2; 12 months post-randomisation 2

  9. Continuous Minimal Residual Disease (MRD)

    Continuous Minimal Residual Disease (MRD) measurements as assessed by flow cytometry will be assessed at various points in trial protocol treatment.

    Measured: Baseline; End of re-induction (after 4-6 cycles of re-induction, each cycle is 28 days); 100 days post-ASCT; After 2 cycles of consolidation (each cycle is 28 days); 8 weeks post-randomisation 2; 12 months post-randomisation 2

  10. Engraftment kinetics_test

    Engraftment kinetics will be summarised based on summaries of stem cell remobilisation protocol and success of remobilisation and stem cell harvest after the completion of ASCT for all participants.

    Measured: Stem cell harvest; 100 days post-ASCT

  11. Incidence of treatment-emergent adverse events (Toxicity and safety)

    Toxicity and safety will be reported based on adverse events, as graded by CTCAE V4.03 and determined by routine clinical assessments at each centre.

    Measured: Baseline; End of each re-induction cycle (each cycle is 28 days); 100 days post-ASCT; End of 2 cycles of consolidation (each cycle is 28 days); 8 weeks post-R2; 3 monthly post-R2 until disease progression; Disease progression, up to 120 months

  12. EORTC QLQ-C30_questionnaire

    The EORTC QLQ-C30 questionnaire will be used to measure participant-assessed quality of life at registration, post re-induction, 100 days post-ASCT and annually post second randomisation until 24 months post second randomisation, or until disease progression whichever is earlier.

    Measured: Baseline; End of re-induction (after 4-6 cycles of re-induction, each cycle is 28 days); 100 days post-ASCT; 12 months post-R2; 24 months post-R2

  13. EORTC QLQ-MY20_questionnaire

    The EORTC QLQ-MY20 questionnaire will be used to measure participant-assessed quality of life at registration, post re-induction, 100 days post-ASCT and annually post second randomisation until 24 months post second randomisation, or until disease progression whichever is earlier.

    Measured: Baseline; End of re-induction (after 4-6 cycles of re-induction, each cycle is 28 days); 100 days post-ASCT; 12 months post-R2; 24 months post-R2

  14. EQ-5D_questionnaire

    The EQ-5D questionnaire will be used to measure participant-assessed quality of life at registration, post re-induction, 100 days post-ASCT and annually post second randomisation until 24 months post second randomisation, or until disease progression whichever is earlier.

    Measured: Baseline; End of re-induction (after 4-6 cycles of re-induction, each cycle is 28 days); 100 days post-ASCT; 12 months post-R2; 24 months post-R2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start20 Mar 2017
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03562169
Sponsor's protocol ID
HM16/047
Other IDs
2016-000905-35, 2016
Status last verified
May 2018
First submitted
6 Dec 2016
Last updated
19 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Striha A, Ashcroft AJ, Hockaday A, Cairns DA, Boardman K, Jacques G, Williams C, Snowden JA, Garg M, Cavenagh J, Yong K, Drayson MT, Owen R, Cook M, Cook G. 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 (ACCoRd [UK-MRA Myeloma XII] trial): study protocol for a Phase III randomised controlled trial. Trials. 2018 Mar 7;19(1):169. doi: 10.1186/s13063-018-2524-8.

    PubMed 29514706

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixazomib, thalidomide, & dexamethasone (ITD) re-induction, Conventional autologous stem cell transplant (ASCT-con) and Augmented autologous stem cell transplant (ASCT-aug) in people with Multiple Myeloma, run by University of Leeds at 91 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gwen Jacques, Senior Trial Coordinator (0044 113 343 1159, ctru-myelomaxii@leeds.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 100 days post-ASCT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.

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