Trial Title: FiTNEss (UK-MRA Myeloma XIV)
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Eligibility criteria for Randomisation 1 (R1) Participants must meet all of the following inclusion criteria and none of the exclusion criteria. Inclusion criteria for R1. 1. Newly diagnosed as having MM according to the updated IMWG diagnostic criteria 2014 requiring treatment. 2. Not eligible for stem cell transplant. 3. Aged at least 18 years. 4. Meet all of the following blood criteria within 14 days before R1: Haematological: 1. Absolute neutrophil count (ANC) ≥ 1 x 10^9/L. Unless the participant has a known/suspected diagnosis of familial or racial neutropenia in which case an ANC ≥ 0.75 x 10^9/L is allowed. The use of growth factor support is permitted. 2. Platelet count ≥ 50 x 10^9/L, or, in the case of heavy bone marrow infiltration (≥ 50%) which in the opinion of the investigator is the cause of the thrombocytopenia and provided appropriate supportive measures and patient monitoring are in place, platelet count ≥ 30 x 10^9/L is permitted. Please note: Platelet transfusions are not allowed ≤ 3 days prior to randomisation in order to meet these values. 3. Haemoglobin ≥ 80 g/L. The use of red blood cell transfusions is permitted. Biochemical: 4. Total bilirubin ≤ 3 x upper limit of normal (ULN). 5. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 x ULN. 5. Meet the pregnancy prevention requirements: Female participants who: 1. Are not of childbearing potential, OR. 2. If they are of childbearing potential, agree to practice 2 effective methods of contraception, 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 participants must consent to) the Celgene-approved Pregnancy Prevention Programme. If female and of childbearing potential, they must have a negative pregnancy test performed by a healthcare professional in accordance with the Celgene Pregnancy Prevention Programme. 6. Able to provide written informed consent. Exclusion criteria for R1. 1. Smouldering MM, MGUS, solitary plasmacytoma of bone, or extramedullary plasmacytoma (without evidence of MM). 2. Received previous treatment for MM, with the exception of local radiotherapy to relieve bone pain or spinal cord compression, prior bisphosphonate treatment, or corticosteroids as long as the total dose does not exceed the equivalent of 160 mg dexamethasone. 3. Known resistance, intolerance or sensitivity to any component of the planned therapies. 4. Prior or concurrent invasive malignancies except the following:
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03720041 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
University of Leeds |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Gordon Cook, MDGraham Jackson, MD |
Principal Investigator Affiliation | University of LeedsFreeman Hospital, Newcastle-Upon-Tyne |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other, Industry |
Overall Status | Recruiting |
Countries | United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Multiple Myeloma |
Active Comparator: R1: IRD induction therapy (reactive)
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.
Experimental: R1: IRD induction therapy (adaptive)
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.
Active Comparator: R2: Lenalidomide plus placebo maintenance
Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus placebo maintenance.
Experimental: R2: Lenalidomide + ixazomib maintenance
Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus ixazomib maintenance.
Drug: - 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.
Drug: - 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: 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 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 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.
Drug: - 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.
Drug: - 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.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
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Aberdeen Royal Infirmary
Aberdeen, ,
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Nevill Hall Hospital
Abergavenny, ,
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Wrightington Hosptial
Appley Bridge, ,
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Ysbyty Gwynedd
Bangor, ,
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North Devon District Hospital
Barnstaple, ,
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Furness General Hospital
Barrow In Furness, ,
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Basingstoke and North Hampshire Hospital
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Royal United Hospital
Bath, ,
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Belfast City Hospital
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Birmingham Heartlands Hospital
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Queen Elizabeth Hospital
Birmingham, ,
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Royal Blackburn Hospital
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Blackpool Victoria Hospital
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Royal Bolton Hospital
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Pilgrim Hospital
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Royal Bournemouth Hospital
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Bradford Royal Infirmary
Bradford, ,
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Bristol Haematology and Oncology Centre
Bristol, ,
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Southmead Hospital
Bristol, ,
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Queen's Hospital
Burton Upon Trent, ,
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Kent and Canterbury Hospital
Canterbury, ,
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Chelmsford & Essex Hospital
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Cheltenham General Hospital
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Countess of Chester Hospital
Chester, ,
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St Richard's Hospital
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Colchester General Hospital
Colchester, ,
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University Hospital Coventry
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Croydon University Hospital
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Royal Derby Hospital
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Dorset County Hospital
Dorchester, ,
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Russells Hall Hospital
Dudley, ,
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Ninewells Hospital
Dundee, ,
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Western General Hospital
Edinburgh, ,
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Royal Devon & Exeter Hospital
Exeter, ,
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Medway Maritime Hospital
Gillingham, ,
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Gloucestershire Royal Hospital
Gloucester, ,
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Grantham and District Hospital
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Diana Princess of Wales Hospital
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Royal Surrey County Hospital
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Calderdale Royal Hospital
Halifax, ,
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Harrogate District Hospital
Harrogate, ,
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Withybush General Hospital
Haverfordwest, ,
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Hereford County Hospital
Hereford, ,
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Huddersfield Royal Infirmary
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Castle Hill Hospital
Hull, ,
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Raigmore Hospital
Inverness, ,
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Ipswich Hospital
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Airedale Hospital
Keighley, ,
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Westmorland General Hospital
Kendal, ,
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Kettering General Hospital
Kettering, ,
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Kidderminster Hospital & Treatment Centre
Kidderminster, ,
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Victoria Hospital
Kirkcaldy, ,
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Royal Lancaster Infirmary
Lancaster, ,
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St James's University Hospital
Leeds, ,
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Leicester Royal Infirmary
Leicester, ,
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Lincoln County Hospital
Lincoln, ,
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Aintree University Hospital
Liverpool, ,
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Royal Liverpool Hospital
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Guy's Hospital
London, ,
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King's College Hospital
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Queen Elizabeth Hospital Greenwich
London, ,
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St Bartholomew's Hospital
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University College Hospital
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University Hospital Lewisham
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Maidstone Hospital
Maidstone, ,
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Manchester Royal Infirmary
Manchester, ,
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James Cook University Hospital
Middlesbrough, ,
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Freeman Hospital
Newcastle, ,
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Royal Gwent Hospital
Newport, ,
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North Tyneside General Hospital
North Shields, ,
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Nottingham City Hospital
Nottingham, ,
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Royal Oldham Hospital
Oldham, ,
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Princess Royal University Hospital
Orpington, ,
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Peterborough City Hospital
Peterborough, ,
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Derriford Hospital
Plymouth, ,
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Whiston Hospital
Prescot, ,
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Royal Preston Hospital
Preston, ,
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Royal Berkshire Hospital
Reading, ,
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Alexandra Hospital
Redditch, ,
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Glan Clwyd Hospital
Rhyl, ,
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Queen's Hospital
Romford, ,
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Salford Royal Hospital
Salford, ,
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Salisbury District Hospital
Salisbury, ,
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Scarborough General Hospital
Scarborough, ,
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Scunthorpe General Hospital
Scunthorpe, ,
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Royal Hallamshire Hospital
Sheffield, ,
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Royal Shrewsbury Hospital
Shrewsbury, ,
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Southampton General Hospital
Southampton, ,
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St Helens Hospital
St Helens, ,
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Stafford County Hospital
Stafford, ,
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Stepping Hill Hospital
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Royal Stoke University Hospital
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Sunderland Royal Hospital
Sunderland, ,
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Good Hope Hospital
Sutton Coldfield, ,
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Singleton Hospital
Swansea, ,
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St George's Hospital
Tooting, ,
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Torbay District General Hospital
Torquay, ,
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Royal Cornwall Hospital
Truro, ,
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Tunbridge Wells Hospital
Tunbridge Wells, ,
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Hillingdon Hospital
Uxbridge, ,
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Pinderfields General Hospital
Wakefield, ,
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Warwick Hospital
Warwick, ,
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Sandwell General Hospital
West Bromwich, ,
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Royal Albert Edward Infirmary
Wigan, ,
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Royal Hampshire County Hospital
Winchester, ,
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New Cross Hospital
Wolverhampton, ,
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Worcestershire Royal Hospital
Worcester, ,
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Worthing Hospital
Worthing, ,
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Wrexham Maelor Hospital
Wrexham, ,
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York Hospital
York, ,