Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| Takeda | INDUSTRY |
| Celgene | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Trial Title:
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R1: IRD induction therapy (reactive) | Active Comparator | 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: IRD induction therapy (adaptive) | Experimental | 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. |
|
| R2: Lenalidomide plus placebo maintenance | Active Comparator | Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus placebo maintenance. |
|
| R2: Lenalidomide + ixazomib maintenance | Experimental | Participants randomised to this arm at Randomisation 2 will receive lenalidomide plus ixazomib maintenance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Randomisation 1: Number of participants with early treatment cessation | Early treatment cessation is defined as a binary endpoint. Participants will be defined to have experienced an event if they die, progress, or are withdrawn from treatment (by a treating clinician) or withdraw consent for trial treatment, within 60 days of Randomisation 1. | Within 60 days of Randomisation 1 |
| Randomisation 2: Progression-free survival (PFS-R2) | PFS-R2 is defined as the time from Randomisation 2 to the time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma. | The time from the date of Randomisation 2 to the date of first documented evidence of disease progression or death from any cause, up to 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS-R1) | PFS-R1 is defined as the time from R1 to the time of first documented evidence of disease progression or death from any cause. Individuals who are lost to follow-up or progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Disease progression is defined according to the IMWG Uniform Response Criteria for Multiple Myeloma. |
| Measure | Description | Time Frame |
|---|---|---|
| Novel frailty risk score (UK-MRA MRP)_composite measure | The prospective validation of a novel frailty risk score (UK Myeloma Research Alliance Myeloma Risk Profile (UK-MRA MRP)) will use the following measurements at baseline to categorise individuals into fit, intermediate-fitness and frail using the UK-MRA MRP:
|
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
Newly diagnosed as having MM according to the updated IMWG diagnostic criteria 2014 requiring treatment.
Not eligible for stem cell transplant.
Aged at least 18 years.
Meet all of the following blood criteria within 14 days before R1:
Haematological:
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.
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.
Haemoglobin ≥ 80 g/L. The use of red blood cell transfusions is permitted.
Biochemical:
Total bilirubin ≤ 3 x upper limit of normal (ULN).
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 x ULN.
Meet the pregnancy prevention requirements:
Female participants who:
Male participants, even if surgically sterilised (i.e. status post-vasectomy), must agree to one of the following:
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.
Able to provide written informed consent.
Exclusion criteria for R1
Smouldering MM, MGUS, solitary plasmacytoma of bone, or extramedullary plasmacytoma (without evidence of MM).
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.
Known resistance, intolerance or sensitivity to any component of the planned therapies.
Prior or concurrent invasive malignancies except the following:
Pregnant, lactating or breastfeeding female participants.
Major surgery within 14 days before randomisation. This would include surgical intervention for relief of cord compression but does not include vertebroplasty or kyphoplasty.
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.
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.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing.
≥ Grade 2 peripheral neuropathy.
Known HIV positive or known hepatitis B surface antigen positive or hepatitis C antibody positive.
Active systemic infection.
Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's participation in this study.
Eligibility criteria for Randomisation 2 (R2) Participants must meet all of the following inclusion criteria and none of the exclusion criteria.
Inclusion criteria for R2
Haematological:
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.
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.
Haemoglobin ≥ 80 g/L. The use of red blood cell transfusions is permitted.
Biochemical:
Total bilirubin ≤ 3 x upper limit of normal (ULN).
Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 3 x ULN.
Exclusion criteria for R2
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.
SD or disease progression according to the IMWG Uniform Response Criteria for Multiple Myeloma.
Known resistance, intolerance or sensitivity to ixazomib or lenalidomide that required cessation of either agent during induction.
Developed any malignancy since R1 except the following:
Pregnant, lactating or breastfeeding female participants.
Major surgery within 14 days before randomisation. This does not include vertebroplasty or kyphoplasty.
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.
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of trial treatment, including difficulty swallowing.
≥ Grade 2 peripheral neuropathy, or grade 1 with pain.
Known HIV positive or known hepatitis B surface antigen positive or hepatitis C antibody positive.
Active systemic infection.
Any other medical or psychiatric condition which, in the opinion of the investigator, contraindicates the participant's continued participation in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rowena Henderson | Contact | +44 (0) 113 343 1159 | ctru_myelomaxiv@leeds.ac.uk | |
| Anna Hockaday | Contact | ctru_myelomaxiv@leeds.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Gordon Cook, MD | University of Leeds | Principal Investigator |
| Graham Jackson, MD | Freeman Hospital, Newcastle-Upon-Tyne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35654466 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase III, multi-centre, randomised, parallel group trial
Not provided
Not provided
Randomisation 1 is open label Randomisation 2 is double-blind, placebo-controlled
|
|
| R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm | Drug | 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:
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 | Drug | 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 | Drug | 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. |
|
|
| The time from the date of Randomisation 1 to the date of first documented evidence of disease progression or death from any cause, up to 120 months |
| Time to disease progression | Time to disease progression is defined for both Randomisation 1 and Randomisation 2 as the time from randomisation to the date of first documented evidence of disease progression. Participants who die prior to documentation of disease progression will be censored in the analysis at their 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. Participants dying from causes not primarily due to progression will also be censored. | The time from the date of randomisation to the date of first documented evidence of disease progression, up to 120 months |
| Progression-free survival two (PFS2) | For both Randomisation 1 and Randomisation 2, progression-free survival two is defined as the time from randomisation to the time of the second documented disease progression. Individuals who are lost to follow-up or second progression-free at the time of analysis will be censored at their last known date to be alive and second progression-free. | The time from the date of randomisation to the date of the second documented disease progression, up to 120 months |
| Overall survival (OS) | Overall survival is defined separately for each randomisation. In each case it is the time from randomisation to the time of death from any cause. Individuals who are lost to follow-up or still alive at the time of analysis will be censored at their last known date to be alive. | The time from the date of randomisation to the date of death from any cause, up to 120 months |
| Survival after progression | Survival after progression is defined from the date of first documented evidence of disease progression to the date of death from any cause. Individuals who are lost to follow-up or alive at the time of analysis will be censored at their last known date to be alive following their first documented evidence of disease progression. | The date of first documented evidence of disease progression to the date of death from any cause, up to 120 months |
| Deaths within 12 months of Randomisation 1 (R1) | Deaths within 12 months of Randomisation 1 is defined as a binary endpoint. Participants will be defined to have experienced an event if they die within 12 months of Randomisation 1. | Within 12 months of Randomisation 1 |
| Overall response rate (ORR) | Overall response rate is defined as a categorical outcome consisting of whether a participant had Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), Minimal Response (MR), Stable Disease (SD) or Progressive Disease (PD) at the end of induction according to the IMWG Uniform Response Criteria for Multiple Myeloma. | From the date of Randomisation 1 to the end of 12 cycles of induction treatment (each induction cycle is 28 days) |
| Attainment of ≥VGPR | Attainment of ≥VGPR is defined as a binary outcome of whether a participant had ≥VGPR (VGPR, CR, sCR) or \ | From the date of Randomisation 1 to the end of 12 cycles of induction treatment (each induction cycle is 28 days) |
| Attainment of Minimal Residual Disease (MRD) negativity | Attainment of Minimal Residual Disease (MRD) negativity is defined as a binary endpoint. MRD negativity will be determined at the end of induction therapy and 12 months post Randomisation 2 according to the IMWG MRD criteria. | From the date of Randomisation 1 to the end of 12 cycles of induction treatment (each induction cycle is 28 days); and 12 months after the date of Randomisation 2 |
| Duration of response (DoR) | Duration of response is defined as the time from the first observation of response ≥ Partial Response (PR), following Randomisation 1, to the time of first documented evidence of disease progression or death confirmed related to progression. Individuals who are lost to follow-up, or still alive and progression-free at the time of analysis will be censored at their last known date to be alive and progression-free. Individuals whose cause of death is unrelated to disease progression will be censored at their date of death. | The time from the date of the first observation of response ≥ Partial Response following Randomisation 1, to the date of first documented evidence of disease progression or death confirmed related to progression, up to 120 months |
| Time to improved response | Time to improved response is defined as the time from the date of Randomisation 2 to the date the response category is first improved based on the Modified International Uniform Response Criteria for Multiple Myeloma. Subjects without any improvement of the baseline status at Randomisation 2 will be censored at the last date of response assessment. | The time from the date of Randomisation 2 to the date the response category is first improved, up to 120 months |
| Time to next treatment | Time to next treatment is defined as the time from Randomisation 1 to the start date of the next line of treatment or death from any cause. | The time from the date of Randomisation 1 to the start date of the next line of treatment or death from any cause, up to 120 months |
| Treatment compliance and total amount of therapy delivered | In the first instance treatment compliance is defined as a binary outcome i.e. did the participant receive 12 cycles of induction treatment. The total amount of therapy delivered will be first defined as the number of induction and maintenance cycles which the participant received. This may be extended to consider the percentage of protocol dose delivered. For each treatment (ixazomib, lenalidomide, dexamethasone) this will be defined as the total dose received in a cycle compared to the total dose the participant should have received in the cycle without modifications, averaged across all cycles of treatment. | Number of induction and maintenance cycles a participant received (each cycle of induction or maintenance is 28 days), until disease progression, up to 120 months |
| Incidence of treatment-emergent adverse events (Toxicity and safety, including incidence of second malignancies) | Toxicity & safety, including incidence of second malignancies Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments at each centre. The number of SAEs will be reported according to MedDRA System Organ Class. All second primary malignancies will be reported based on information collected on the Case Report Form. | Baseline, end of each induction cycle (each induction cycle is 28 days), end of each maintenance cycle (each maintenance cycle is 28 days), until disease progression, up to 120 months |
| EORTC QLQ-C30_questionnaire | European Organization for the Research & Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is used to measure patient-assessed quality of life (QoL) at R1, after cycles 2, 4, 6 & 12 of induction, and after cycles 6 and 12 of maintenance (all cycles are 28 days). The QLQ-C30 comprises multi-item scales & single-item measures: 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea & vomiting), a global health status/QoL scale, & 6 single items assessing additional symptoms (dyspnoea, loss of appetite, insomnia, constipation & diarrhoea). All scales & single-item measures range in score from 0 to 100. A high scale score represents a higher response level: a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high quality of life, but a high score for a symptom scale/item represents a high level of symptomatology/problems. | Randomisation 1; after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle is 28 days); after cycles 6 and 12 of maintenance treatment (each maintenance cycle is 28 days) |
| EORTC QLQ-MY20_questionnaire | The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Multiple Myeloma Module (EORTC QLQ-MY20) is used to measure patient-assessed quality of life (QoL) at Randomisation 1, after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle is 28 days), and after cycles 6 and 12 of maintenance treatment (each maintenance cycle is 28 days). The EORTC QLQ-MY20 comprises 20 questions that address four myeloma-specific QoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspectives, and Body Image. Disease Symptoms, Side Effects of Treatment, and Future Perspectives are all multi-item scales, and Body Image is a single-item scale. Domain scores are averaged and transformed linearly to a score ranging from 0-100. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes. | Randomisation 1; after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle is 28 days); after cycles 6 and 12 of maintenance treatment (each maintenance cycle is 28 days) |
| EQ-5D-3L_questionnaire | The EuroQol 5 Dimension 3 Level questionnaire (EQ-5D-3L) will be used to measure participant-assessed quality of life at Randomisation 1, after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle is 28 days), and after cycles 6 and 12 of maintenance treatment (each maintenance cycle is 28 days). The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | Randomisation 1; after cycles 2, 4, 6 and 12 of induction treatment (each induction cycle is 28 days); after cycles 6 and 12 of maintenance treatment (each maintenance cycle is 28 days) |
| Through study completion, up to 120 months |
| Usefulness of Karnofsky PS_composite measure | The Karnofsky Performance Status will be contrasted with the Eastern Cooperative Oncology Group (ECOG) Performance Status to consider whether it can appropriately measure the performance status of patients with multiple myeloma. | Through study completion, up to 120 months |
| Nevill Hall Hospital | Not yet recruiting | Abergavenny | United Kingdom |
|
| Wrightington Hosptial | Not yet recruiting | Appley Bridge | United Kingdom |
|
| Ysbyty Gwynedd | Not yet recruiting | Bangor | United Kingdom |
|
| North Devon District Hospital | Not yet recruiting | Barnstaple | United Kingdom |
|
| Furness General Hospital | Not yet recruiting | Barrow in Furness | United Kingdom |
|
| Basingstoke and North Hampshire Hospital | Not yet recruiting | Basingstoke | United Kingdom |
|
| Royal United Hospital | Not yet recruiting | Bath | United Kingdom |
|
| Belfast City Hospital | Not yet recruiting | Belfast | United Kingdom |
|
| Birmingham Heartlands Hospital | Not yet recruiting | Birmingham | United Kingdom |
|
| Queen Elizabeth Hospital | Not yet recruiting | Birmingham | United Kingdom |
|
| Royal Blackburn Hospital | Not yet recruiting | Blackburn | United Kingdom |
|
| Blackpool Victoria Hospital | Recruiting | Blackpool | United Kingdom |
|
| Royal Bolton Hospital | Not yet recruiting | Bolton | United Kingdom |
|
| Pilgrim Hospital | Not yet recruiting | Boston | United Kingdom |
|
| Royal Bournemouth Hospital | Recruiting | Bournemouth | United Kingdom |
|
| Bradford Royal Infirmary | Not yet recruiting | Bradford | United Kingdom |
|
| Bristol Haematology and Oncology Centre | Recruiting | Bristol | United Kingdom |
|
| Southmead Hospital | Not yet recruiting | Bristol | United Kingdom |
|
| Queen's Hospital | Not yet recruiting | Burton-on-Trent | United Kingdom |
|
| Kent and Canterbury Hospital | Recruiting | Canterbury | United Kingdom |
|
| Chelmsford & Essex Hospital | Not yet recruiting | Chelmsford | United Kingdom |
|
| Cheltenham General Hospital | Recruiting | Cheltenham | United Kingdom |
|
| Countess of Chester Hospital | Not yet recruiting | Chester | United Kingdom |
|
| St Richard's Hospital | Not yet recruiting | Chichester | United Kingdom |
|
| Colchester General Hospital | Not yet recruiting | Colchester | United Kingdom |
|
| University Hospital Coventry | Not yet recruiting | Coventry | United Kingdom |
|
| Croydon University Hospital | Not yet recruiting | Croydon | United Kingdom |
|
| Royal Derby Hospital | Not yet recruiting | Derby | United Kingdom |
|
| Dorset County Hospital | Not yet recruiting | Dorchester | United Kingdom |
|
| Russells Hall Hospital | Not yet recruiting | Dudley | United Kingdom |
|
| Ninewells Hospital | Not yet recruiting | Dundee | United Kingdom |
|
| Western General Hospital | Not yet recruiting | Edinburgh | United Kingdom |
|
| Royal Devon & Exeter Hospital | Not yet recruiting | Exeter | United Kingdom |
|
| Medway Maritime Hospital | Not yet recruiting | Gillingham | United Kingdom |
|
| Gloucestershire Royal Hospital | Not yet recruiting | Gloucester | United Kingdom |
|
| Grantham and District Hospital | Not yet recruiting | Grantham | United Kingdom |
|
| Diana Princess of Wales Hospital | Not yet recruiting | Grimsby | United Kingdom |
|
| Royal Surrey County Hospital | Not yet recruiting | Guildford | United Kingdom |
|
| Calderdale Royal Hospital | Not yet recruiting | Halifax | United Kingdom |
|
| Harrogate District Hospital | Not yet recruiting | Harrogate | United Kingdom |
|
| Withybush General Hospital | Not yet recruiting | Haverfordwest | United Kingdom |
|
| Hereford County Hospital | Not yet recruiting | Hereford | United Kingdom |
|
| Huddersfield Royal Infirmary | Not yet recruiting | Huddersfield | United Kingdom |
|
| Castle Hill Hospital | Not yet recruiting | Hull | United Kingdom |
|
| Raigmore Hospital | Not yet recruiting | Inverness | United Kingdom |
|
| Ipswich Hospital | Not yet recruiting | Ipswich | United Kingdom |
|
| Airedale Hospital | Not yet recruiting | Keighley | United Kingdom |
|
| Westmorland General Hospital | Not yet recruiting | Kendal | United Kingdom |
|
| Kettering General Hospital | Not yet recruiting | Kettering | United Kingdom |
|
| Kidderminster Hospital & Treatment Centre | Not yet recruiting | Kidderminster | United Kingdom |
|
| Victoria Hospital | Not yet recruiting | Kirkcaldy | United Kingdom |
|
| Royal Lancaster Infirmary | Not yet recruiting | Lancaster | United Kingdom |
|
| St James's University Hospital | Not yet recruiting | Leeds | United Kingdom |
|
| Leicester Royal Infirmary | Not yet recruiting | Leicester | United Kingdom |
|
| Lincoln County Hospital | Not yet recruiting | Lincoln | United Kingdom |
|
| Aintree University Hospital | Not yet recruiting | Liverpool | United Kingdom |
|
| Royal Liverpool Hospital | Not yet recruiting | Liverpool | United Kingdom |
|
| Guy's Hospital | Not yet recruiting | London | United Kingdom |
|
| King's College Hospital | Not yet recruiting | London | United Kingdom |
|
| Queen Elizabeth Hospital Greenwich | Not yet recruiting | London | United Kingdom |
|
| St Bartholomew's Hospital | Not yet recruiting | London | United Kingdom |
|
| University College Hospital | Recruiting | London | United Kingdom |
|
| University Hospital Lewisham | Not yet recruiting | London | United Kingdom |
|
| Maidstone Hospital | Not yet recruiting | Maidstone | United Kingdom |
|
| Manchester Royal Infirmary | Recruiting | Manchester | United Kingdom |
|
| James Cook University Hospital | Not yet recruiting | Middlesbrough | United Kingdom |
|
| Freeman Hospital | Recruiting | Newcastle | United Kingdom |
|
| Royal Gwent Hospital | Not yet recruiting | Newport | United Kingdom |
|
| North Tyneside General Hospital | Not yet recruiting | North Shields | United Kingdom |
|
| Nottingham City Hospital | Not yet recruiting | Nottingham | United Kingdom |
|
| Royal Oldham Hospital | Not yet recruiting | Oldham | United Kingdom |
|
| Princess Royal University Hospital | Not yet recruiting | Orpington | United Kingdom |
|
| Peterborough City Hospital | Not yet recruiting | Peterborough | United Kingdom |
|
| Derriford Hospital | Not yet recruiting | Plymouth | United Kingdom |
|
| Whiston Hospital | Not yet recruiting | Prescot | United Kingdom |
|
| Royal Preston Hospital | Not yet recruiting | Preston | United Kingdom |
|
| Royal Berkshire Hospital | Recruiting | Reading | United Kingdom |
|
| Alexandra Hospital | Not yet recruiting | Redditch | United Kingdom |
|
| Glan Clwyd Hospital | Not yet recruiting | Rhyl | United Kingdom |
|
| Queen's Hospital | Not yet recruiting | Romford | United Kingdom |
|
| Tunbridge Wells Hospital | Not yet recruiting | Royal Tunbridge Wells | United Kingdom |
|
| Salford Royal Hospital | Not yet recruiting | Salford | United Kingdom |
|
| Salisbury District Hospital | Not yet recruiting | Salisbury | United Kingdom |
|
| Scarborough General Hospital | Not yet recruiting | Scarborough | United Kingdom |
|
| Scunthorpe General Hospital | Not yet recruiting | Scunthorpe | United Kingdom |
|
| Royal Hallamshire Hospital | Not yet recruiting | Sheffield | United Kingdom |
|
| Royal Shrewsbury Hospital | Not yet recruiting | Shrewsbury | United Kingdom |
|
| Southampton General Hospital | Not yet recruiting | Southampton | United Kingdom |
|
| St Helens Hospital | Not yet recruiting | St Helens | United Kingdom |
|
| Stafford County Hospital | Not yet recruiting | Stafford | United Kingdom |
|
| Stepping Hill Hospital | Not yet recruiting | Stockport | United Kingdom |
|
| Royal Stoke University Hospital | Not yet recruiting | Stoke-on-Trent | United Kingdom |
|
| Sunderland Royal Hospital | Not yet recruiting | Sunderland | United Kingdom |
|
| Good Hope Hospital | Not yet recruiting | Sutton Coldfield | United Kingdom |
|
| Singleton Hospital | Not yet recruiting | Swansea | United Kingdom |
|
| St George's Hospital | Not yet recruiting | Tooting | United Kingdom |
|
| Torbay District General Hospital | Not yet recruiting | Torquay | United Kingdom |
|
| Royal Cornwall Hospital | Not yet recruiting | Truro | United Kingdom |
|
| Hillingdon Hospital | Not yet recruiting | Uxbridge | United Kingdom |
|
| Pinderfields General Hospital | Not yet recruiting | Wakefield | United Kingdom |
|
| Warwick Hospital | Not yet recruiting | Warwick | United Kingdom |
|
| Sandwell General Hospital | Not yet recruiting | West Bromwich | United Kingdom |
|
| Royal Albert Edward Infirmary | Not yet recruiting | Wigan | United Kingdom |
|
| Royal Hampshire County Hospital | Not yet recruiting | Winchester | United Kingdom |
|
| New Cross Hospital | Not yet recruiting | Wolverhampton | United Kingdom |
|
| Worcestershire Royal Hospital | Not yet recruiting | Worcester | United Kingdom |
|
| Worthing Hospital | Not yet recruiting | Worthing | United Kingdom |
|
| Wrexham Maelor Hospital | Not yet recruiting | Wrexham | United Kingdom |
|
| York Hospital | Not yet recruiting | York | United Kingdom |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003907 | Dexamethasone |
| C548400 | ixazomib |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided