Myeloma XIV: Frailty-adjusted Therapy in Transplant Non-Eligible Patients With Newly Diagnosed Multiple Myeloma
NCT ID: NCT03720041
Last Updated: 2021-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
740 participants
INTERVENTIONAL
2020-08-04
2024-12-31
Brief Summary
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FiTNEss (UK-MRA Myeloma XIV) - Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma
Overview:
A phase III, multi-centre, randomised controlled trial to compare standard (reactive) and frailty-adjusted (adaptive) induction therapy delivery with the novel triplet ixazomib, lenalidomide and dexamethasone (IRD), and to compare maintenance lenalidomide (R) to lenalidomide plus ixazomib (R+I) in patients with newly diagnosed multiple myeloma not suitable for a stem cell transplant.
All participants receive induction treatment with ixazomib, lenalidomide and dexamethasone and are randomised on a 1:1 basis at trial entry to the use of frailty score-adjusted up-front dose reductions vs. standard up-front dosing followed by toxicity dependent reactive dose-modifications during therapy. Following 12 cycles of induction treatment participants alive and progression-free undergo a second randomisation on a 1:1 basis to maintenance treatment with lenalidomide plus placebo versus lenalidomide plus ixazomib. Participants and their treating physicians will be blinded to maintenance allocation.
Participant population:
* Newly diagnosed as having Multiple Myeloma (MM) according to the updated IMWG diagnostic criteria 2014 (see Appendix 1 for criteria)
* Not eligible for stem cell transplant
* Aged at least 18 years
* Able to provide written informed consent
Number of participants:
740 participants will be entered into the trial at Randomisation 1 (R1), with 478 participants at Randomisation 2 (R2).
Objectives:
The primary objectives of this study are to determine:
* Early treatment cessation (within 60 days of randomisation) for standard versus frailty-adjusted up-front dosing
* Progression-free survival (PFS, from maintenance randomisation) for lenalidomide + placebo (R) versus lenalidomide + ixazomib (R+I)
The secondary objectives of this study are to assess progression-free survival (PFS) for standard versus frailty-adjusted up-front dosing reductions, time to progression, time to 2nd PFS event (PFS2), overall survival (OS), survival after progression, deaths within 12 months of R1, overall response rate (ORR), attainment of ≥VGPR, attainment of MRD negativity, duration of response, time to improved response, time to next treatment, treatment compliance and total amount of therapy delivered, toxicity \& safety including the incidence of SPMs, Quality of Life (QoL), cost effectiveness of standard versus frailty-adjusted up-front dosing of IRD and cost-effectiveness of R + I versus R.
Exploratory objectives are prospective validation of a novel frailty risk score (UK-MRA Myeloma Risk Profile - MRP), usefulness of Karnofsky Performance Status (PS), and association of molecular subgroups with response, PFS and OS.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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:
1. 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
2. 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
3. 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.
R2: Lenalidomide plus placebo maintenance
Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus placebo maintenance.
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.
R2: Lenalidomide + ixazomib maintenance
Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus ixazomib maintenance.
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.
Interventions
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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.
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:
1. 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
2. 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
3. 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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
1. Randomised into the FiTNEss (Myeloma XIV) trial and received induction chemotherapy with ixazomib and lenalidomide continued for 12 cycles.
2. Achieved at least MR at the end of IRD induction according to the IMWG Uniform Response Criteria for Multiple Myeloma, with no evidence of progression prior to R2.
3. Meet all of the following blood criteria within 14 days before R2:
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. 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.
Exclusion Criteria
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:
* Adequately treated basal cell or squamous cell skin cancer;
* Incidental finding of low grade (Gleason 3+3 or less) prostate cancer requiring no intervention;
* Adequately treated carcinoma in situ of the breast or cervix no longer requiring medical or surgical intervention;
* Any cancer from which the subject has been disease-free for at least 3 years.
5. Pregnant, lactating or breastfeeding female participants.
6. Major surgery within 14 days before randomisation. This would include surgical intervention for relief of cord compression but does not include vertebroplasty or kyphoplasty.
7. Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
8. Any concomitant drug therapy which, in the opinion of the investigator, may lead to an unacceptable interaction with any of the agents ixazomib, lenalidomide, dexamethasone, and that cannot be safely stopped prior to trial entry. Full details of interactions can be found in the SPCs.
9. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing.
10. ≥ Grade 2 peripheral neuropathy.
11. Known HIV positive or known hepatitis B surface antigen positive or hepatitis C antibody positive.
12. Active systemic infection.
13. Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.
1. Received any anti-myeloma therapy other than their randomised trial treatment, with the exception of local radiotherapy to relieve bone pain (in the absence of disease progression), or bisphosphonate treatment.
2. SD or disease progression according to the IMWG Uniform Response Criteria for Multiple Myeloma.
3. Known resistance, intolerance or sensitivity to ixazomib or lenalidomide that required cessation of either agent during induction.
4. Developed any malignancy since R1 except the following:
* Adequately treated basal cell or squamous cell skin cancer;
* Incidental finding of low grade (Gleason 3+3 or less) prostate cancer requiring no intervention;
* Adequately treated carcinoma in situ of the breast or cervix no longer requiring medical or surgical intervention.
5. Pregnant, lactating or breastfeeding female participants.
6. Major surgery within 14 days before randomisation. This does not include vertebroplasty or kyphoplasty.
7. Systemic treatment, within 14 days before the first dose of ixazomib with strong CYP3A inducers (e.g. rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. John's wort.
8. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing.
9. ≥ Grade 2 peripheral neuropathy, or grade 1 with pain.
10. Known HIV positive or known hepatitis B surface antigen positive or hepatitis C antibody positive.
11. Active systemic infection.
12. Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's continued participation in this study.
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Takeda
INDUSTRY
Celgene
INDUSTRY
University of Leeds
OTHER
Responsible Party
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Principal Investigators
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Gordon Cook, MD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Graham Jackson, MD
Role: PRINCIPAL_INVESTIGATOR
Freeman Hospital, Newcastle-Upon-Tyne
Locations
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Hillingdon Hospital
Uxbridge, , United Kingdom
Pinderfields General Hospital
Wakefield, , United Kingdom
Warwick Hospital
Warwick, , United Kingdom
Sandwell General Hospital
West Bromwich, , United Kingdom
Royal Albert Edward Infirmary
Wigan, , United Kingdom
Royal Hampshire County Hospital
Winchester, , United Kingdom
Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Nevill Hall Hospital
Abergavenny, , United Kingdom
Wrightington Hosptial
Appley Bridge, , United Kingdom
Ysbyty Gwynedd
Bangor, , United Kingdom
North Devon District Hospital
Barnstaple, , United Kingdom
Furness General Hospital
Barrow in Furness, , United Kingdom
Basingstoke and North Hampshire Hospital
Basingstoke, , United Kingdom
Royal United Hospital
Bath, , United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Blackburn Hospital
Blackburn, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Royal Bolton Hospital
Bolton, , United Kingdom
Pilgrim Hospital
Boston, , United Kingdom
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Queen's Hospital
Burton-on-Trent, , United Kingdom
Kent and Canterbury Hospital
Canterbury, , United Kingdom
Chelmsford & Essex Hospital
Chelmsford, , United Kingdom
Cheltenham General Hospital
Cheltenham, , United Kingdom
Countess of Chester Hospital
Chester, , United Kingdom
St Richard's Hospital
Chichester, , United Kingdom
Colchester General Hospital
Colchester, , United Kingdom
University Hospital Coventry
Coventry, , United Kingdom
Croydon University Hospital
Croydon, , United Kingdom
Royal Derby Hospital
Derby, , United Kingdom
Dorset County Hospital
Dorchester, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Royal Devon & Exeter Hospital
Exeter, , United Kingdom
Medway Maritime Hospital
Gillingham, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Grantham and District Hospital
Grantham, , United Kingdom
Diana Princess of Wales Hospital
Grimsby, , United Kingdom
Royal Surrey County Hospital
Guildford, , United Kingdom
Calderdale Royal Hospital
Halifax, , United Kingdom
Harrogate District Hospital
Harrogate, , United Kingdom
Withybush General Hospital
Haverfordwest, , United Kingdom
Hereford County Hospital
Hereford, , United Kingdom
Huddersfield Royal Infirmary
Huddersfield, , United Kingdom
Castle Hill Hospital
Hull, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Ipswich Hospital
Ipswich, , United Kingdom
Airedale Hospital
Keighley, , United Kingdom
Westmorland General Hospital
Kendal, , United Kingdom
Kettering General Hospital
Kettering, , United Kingdom
Kidderminster Hospital & Treatment Centre
Kidderminster, , United Kingdom
Victoria Hospital
Kirkcaldy, , United Kingdom
Royal Lancaster Infirmary
Lancaster, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Lincoln County Hospital
Lincoln, , United Kingdom
Aintree University Hospital
Liverpool, , United Kingdom
Royal Liverpool Hospital
Liverpool, , United Kingdom
Guy's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Queen Elizabeth Hospital Greenwich
London, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
University Hospital Lewisham
London, , United Kingdom
Maidstone Hospital
Maidstone, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
James Cook University Hospital
Middlesbrough, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Royal Gwent Hospital
Newport, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Royal Oldham Hospital
Oldham, , United Kingdom
Princess Royal University Hospital
Orpington, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Whiston Hospital
Prescot, , United Kingdom
Royal Preston Hospital
Preston, , United Kingdom
Royal Berkshire Hospital
Reading, , United Kingdom
Alexandra Hospital
Redditch, , United Kingdom
Glan Clwyd Hospital
Rhyl, , United Kingdom
Queen's Hospital
Romford, , United Kingdom
Tunbridge Wells Hospital
Royal Tunbridge Wells, , United Kingdom
Salford Royal Hospital
Salford, , United Kingdom
Salisbury District Hospital
Salisbury, , United Kingdom
Scarborough General Hospital
Scarborough, , United Kingdom
Scunthorpe General Hospital
Scunthorpe, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
St Helens Hospital
St Helens, , United Kingdom
Stafford County Hospital
Stafford, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Good Hope Hospital
Sutton Coldfield, , United Kingdom
Singleton Hospital
Swansea, , United Kingdom
St George's Hospital
Tooting, , United Kingdom
Torbay District General Hospital
Torquay, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
Worthing Hospital
Worthing, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
York Hospital
York, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Jane Tighe
Role: primary
Grant Robinson
Role: primary
Christopher Gregory
Role: primary
Sally Evans
Role: primary
Paul Kerr
Role: primary
David Howart
Role: primary
Noel Ryman
Role: primary
Sally Moore
Role: primary
Sarah Lawless
Role: primary
Bhuvan Kishore
Role: primary
Guy Pratt
Role: primary
Jagdish Adiyodi
Role: primary
Mark Grey
Role: primary
Chetan Patalappa
Role: primary
Charlotte Kallmeyer
Role: primary
Rachel Hall
Role: primary
Anshu Garg
Role: primary
Jenny Bird
Role: primary
Alastair Whiteway
Role: primary
Humayun Ahmad
Role: primary
Jindriska Lindsay
Role: primary
Pavel Kotoucek
Role: primary
Michael Shields
Role: primary
Arvind Pillai
Role: primary
Santosh Narat
Role: primary
Mike Hamblin
Role: primary
Francesca Jones
Role: primary
Fathi Al-Jehani
Role: primary
David Allotey
Role: primary
Richard Karim
Role: primary
Rupert Hipkins
Role: primary
Gordon Marron
Role: primary
Huw Roddie
Role: primary
Paul Kerr
Role: primary
Sarah Arnott
Role: primary
Michael Shields
Role: primary
Charlotte Kallmeyer
Role: primary
Sanjeev Jalihal
Role: primary
Elisabeth Grey-Davies
Role: primary
Sylvia Feyler
Role: primary
Tharani Balasubramaniam
Role: primary
Sumant Kundu
Role: primary
Lisa Robinson
Role: primary
Sylvia Feyler
Role: primary
Senthilkumar Durairaj
Role: primary
Peter Forsyth
Role: primary
Isobel Chalmers
Role: primary
Michail Spondoudakis
Role: primary
David Howart
Role: primary
Avrangzeb Razzak
Role: primary
Salim Shafeek
Role: primary
Victoria Campbell
Role: primary
David Howart
Role: primary
Gordon Cook
Role: primary
Mamta Garg
Role: primary
Charlotte Kallmeyer
Role: primary
Lynny Yung
Role: primary
Gillian Brearton
Role: primary
Matthew Streetly
Role: primary
Stella Bowcock
Role: primary
Sunil Gupta
Role: primary
Simon Hallam
Role: primary
Neil Rabin
Role: primary
Sunil Gupta
Role: primary
Lalita Banerjee
Role: primary
Alberto Rocci
Role: primary
Marianna David
Role: primary
Graham Jackson
Role: primary
Helen Jackson
Role: primary
Charlotte Bomken
Role: primary
Dean Smith
Role: primary
Antonina Zhelyazkova
Role: primary
Stella Bowcock
Role: primary
Alexis Fowler
Role: primary
Hannah Hunter
Role: primary
Toby Nicholson
Role: primary
Mark Grey
Role: primary
Pratap Neelakantan
Role: primary
Salim Shafeek
Role: primary
Earnest Heartin
Role: primary
Sandra Hassan
Role: primary
Lalita Banerjee
Role: primary
Rowena Thomas-Dewing
Role: primary
Jonathan Cullis
Role: primary
Laura Munro
Role: primary
Sanjeev Jalihal
Role: primary
Andrew Chantry
Role: primary
Emma Litt
Role: primary
Matthew Jenner
Role: primary
Toby Nicholson
Role: primary
Paul Ferguson
Role: primary
Montaser Haj
Role: primary
Paul Ferguson
Role: primary
Victoria Hervey
Role: primary
Bhuvan Kishore
Role: primary
Hamdi Sati
Role: primary
Fenella Willis
Role: primary
Heather Eve
Role: primary
Julie Blundell
Role: primary
Richard Kaczmarski
Role: primary
John Ashcroft
Role: primary
Anton Borg
Role: primary
Farooq Wandroo
Role: primary
Christopher Gregory
Role: primary
Noel Ryman
Role: primary
Supratik Basu
Role: primary
Salim Shafeek
Role: primary
Santosh Narat
Role: primary
Lally Desoysa
Role: primary
Laura Munro
Role: primary
References
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Coulson AB, Royle KL, Pawlyn C, Cairns DA, Hockaday A, Bird J, Bowcock S, Kaiser M, de Tute R, Rabin N, Boyd K, Jones J, Parrish C, Gardner H, Meads D, Dawkins B, Olivier C, Henderson R, Best P, Owen R, Jenner M, Kishore B, Drayson M, Jackson G, Cook G. Frailty-adjusted therapy in Transplant Non-Eligible patients with newly diagnosed Multiple Myeloma (FiTNEss (UK-MRA Myeloma XIV Trial)): a study protocol for a randomised phase III trial. BMJ Open. 2022 Jun 2;12(6):e056147. doi: 10.1136/bmjopen-2021-056147.
Other Identifiers
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MyelomaXIV
Identifier Type: -
Identifier Source: org_study_id
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