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2. Maintenance lenalidomide in newly diagnosed transplant eligible and non-eligible myeloma patients; profiling second primary malignancies in 4358 patients treated in the Myeloma XI Trial

Author

Jones, John R., Cairns, David A., Menzies, Tom, Pawlyn, Charlotte, Davies, Faith E., Sigsworth, Rachel, Brioli, Annamaria, Jenner, Matthew W., Kaiser, Martin F., Olivier, Catherine, Reed, Molly, Drayson, Mark T., Owen, Roger G., Boyd, Kevin D., Cook, Gordon, Morgan, Gareth J., and Jackson, Graham H.

Published
2023
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7. Brief cycling intervals incrementally increase the number of hematopoietic stem and progenitor cells in human peripheral blood.

Author

Pradana, Fendi, Nijjar, Tarondeep, Cox, Phoebe A., Morgan, Paul T., Podlogar, Tim, Lucas, Samuel J. E., Drayson, Mark T., Kinsella, Francesca A. M., and Wadley, Alex J.

Subjects
HEMATOPOIETIC stem cell transplantation, KILLER cells, HEMATOPOIETIC stem cells, HUMAN stem cells, BLOOD cells
Abstract

Introduction: Peripheral blood stem cell (PBSC) donation is the primary procedure used to collect hematopoietic stem and progenitor cells (HSPCs) for hematopoietic stem cell transplantation. Single bouts of exercise transiently enrich peripheral blood with HSPCs and cytolytic natural killer cells (CD56dim), which are important in preventing post-transplant complications. To provide a rationale to investigate the utility of exercise in a PBSC donation setting (=3 h), this study aimed to establish whether interval cycling increased peripheral blood HSPC and CD56dim concentrations to a greater degree than continuous cycling. Methods: In a randomised crossover study design, eleven males (mean ± SD: age 25 ± 7 years) undertook bouts of moderate intensity continuous exercise [MICE, 30 min, 65%-70% maximum heart rate (HRmax)], high-volume high intensity interval exercise (HV-HIIE, 4 × 4 min, 80%-85% HRmax) and low-volume HIIE (LV-HIIE, 4 × 2 min, 90%-95% HRmax). The cumulative impact of each interval on circulating HSPC (CD34+CD45dimSSClow) and CD56dim concentrations (cells/µL), and the bone marrow homing potential of HSPCs (expression of CXCR-4 and VLA-4) were determined. Results: There was an increase in HSPC concentration after two intervals of LVHIIE (Rest: 1.84 ± 1.55 vs. Interval 2: 2.94 ± 1.34, P = 0.01) and three intervals of HV-HIIE only (Rest: 2.05 ± 0.86 vs. Interval 3: 2.51 ± 1.05, P = 0.04). The concentration of all leukocyte subsets increased after each trial, with this greatest for CD56dim NK cells, and in HIIE vs. MICE (LV-HIIE: 4.77 ± 2.82, HVHIIE: 4.65 ± 2.06, MICE: 2.44 ± 0.77, P < 0.0001). These patterns were observed for concentration, not frequency of CXCR-4+ and VLA-4+ HSPCs, which was unaltered. There was a marginal decrease in VLA-4, but not CXCR-4 expression on exercise-mobilised HSPCs after all trials (P < 0.0001). Discussion: The results of the present study indicate that HIIE caused a more marked increase in HSPC and CD56dim NK cell concentrations than MICE, with mobilised HSPCs maintaining their bone marrow homing phenotype. LV-HIIE evoked an increase in HSPC concentration after just 2 × 2-minute intervals. The feasibility and clinical utility of interval cycling in a PBSC donation context should therefore be evaluated. [ABSTRACT FROM AUTHOR]

Published
2024
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8. Sensitive Detection of SARS-CoV-2-Specific Antibodies in Dried Blood Spot Samples

Author

Morley, Gabriella L., Taylor, Stephen, Jossi, Sian, Perez-Toledo, Marisol, Faustini, Sian E., Marcial-Juarez, Edith, Shields, Adrian M., Goodall, Margaret, Allen, Joel D., Watanabe, Yasunori, Newby, Maddy L., Crispin, Max, Drayson, Mark T., Cunningham, Adam F., Richter, Alex G., and OShea, Matthew K.

Subjects
Blood -- Medical examination, Serodiagnosis -- Methods, Health
Abstract

A confirmed diagnosis of acute coronavirus disease (COVID-19) depends on the detection of RNA from the causative pathogen, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In contrast, although serologic testing [...]

Published
2020
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11. Pathogen and human NDPK-proteins promote AML cell survival via monocyte NLRP3-inflammasome activation

Author

Trova, Sandro, primary, Lin, Fei, additional, Lomada, Santosh, additional, Fenton, Matthew, additional, Chauhan, Bhavini, additional, Adams, Alexandra, additional, Puri, Avani, additional, Di Maio, Alessandro, additional, Wieland, Thomas, additional, Sewell, Daniel, additional, Dick, Kirstin, additional, Wiseman, Daniel, additional, Wilks, Deepti P., additional, Goodall, Margaret, additional, Drayson, Mark T., additional, Khanim, Farhat L., additional, and Bunce, Christopher M., additional

Published
2023
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14. Presenting Symptoms in Newly Diagnosed Myeloma, Relation to Organ Damage, and Implications for Symptom-Directed Screening: A Secondary Analysis from the Tackling Early Morbidity and Mortality in Myeloma (TEAMM) Trial

Author

Bowcock, Stella, primary, Atkin, Catherine, additional, Iqbal, Gulnaz, additional, Pratt, Guy, additional, Yong, Kwee, additional, Neal, Richard D., additional, Planche, Tim, additional, Karunanithi, Kamaraj, additional, Jenkins, Stephen, additional, Stern, Simon, additional, Arnott, Sarah, additional, Toth, Peter, additional, Wandroo, Farooq, additional, Dunn, Janet, additional, and Drayson, Mark T., additional

Published
2023
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15. SARS-CoV-2 infection is associated with anti-desmoglein 2 autoantibody detection

Author

Ward, Kerensa E, primary, Steadman, Lora, additional, Karim, Abid R, additional, Reynolds, Gary M, additional, Pugh, Matthew, additional, Chua, Winnie, additional, Faustini, Sian E, additional, Veenith, Tonny, additional, Thwaites, Ryan S, additional, Openshaw, Peter J M, additional, Drayson, Mark T, additional, Shields, Adrian M, additional, Cunningham, Adam F, additional, Wraith, David C, additional, and Richter, Alex G, additional

Published
2023
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20. Carfilzomib, lenalidomide, dexamethasone, and cyclophosphamide (KRdc) as induction therapy for transplant-eligible, newly diagnosed multiple myeloma patients (Myeloma XI+): Interim analysis of an open-label randomised controlled trial

Author

Jackson, Graham H., Pawlyn, Charlotte, Cairns, David A., de Tute, Ruth M., Hockaday, Anna, Collett, Corinne, Jones, John R., Kishore, Bhuvan, Garg, Mamta, Williams, Cathy D., Karunanithi, Kamaraj, Lindsay, Jindriska, Rocci, Alberto, Snowden, John A., Jenner, Matthew W., Cook, Gordon, Russell, Nigel H., Drayson, Mark T., Gregory, Walter M., Kaiser, Martin F., Owen, Roger G., Davies, Faith E., and Morgan, Gareth J.

Subjects
Cyclophosphamide -- Dosage and administration, Dexamethasone -- Dosage and administration, Multiple myeloma -- Drug therapy, Chemotherapy -- Methods, Carfilzomib -- Dosage and administration, Cancer -- Chemotherapy, Biological sciences
Abstract

Background Carfilzomib is a second-generation irreversible proteasome inhibitor that is efficacious in the treatment of myeloma and carries less risk of peripheral neuropathy than first-generation proteasome inhibitors, making it more amenable to combination therapy. Methods and findings The Myeloma XI+ trial recruited patients from 88 sites across the UK between 5 December 2013 and 20 April 2016. Patients with newly diagnosed multiple myeloma eligible for transplantation were randomly assigned to receive the combination carfilzomib, lenalidomide, dexamethasone, and cyclophosphamide (KRdc) or a triplet of lenalidomide, dexamethasone, and cyclophosphamide (Rdc) or thalidomide, dexamethasone, and cyclophosphamide (Tdc). All patients were planned to receive an autologous stem cell transplantation (ASCT) prior to a randomisation between lenalidomide maintenance and observation. Eligible patients were aged over 18 years and had symptomatic myeloma. The co-primary endpoints for the study were progression-free survival (PFS) and overall survival (OS) for KRdc versus the Tdc/Rdc control group by intention to treat. PFS, response, and safety outcomes are reported following a planned interim analysis. The trial is registered (ISRCTN49407852) and has completed recruitment. In total, 1,056 patients (median age 61 years, range 33 to 75, 39.1% female) underwent induction randomisation to KRdc (n = 526) or control (Tdc/Rdc, n = 530). After a median follow-up of 34.5 months, KRdc was associated with a significantly longer PFS than the triplet control group (hazard ratio 0.63, 95% CI 0.51-0.76). The median PFS for patients receiving KRdc is not yet estimable, versus 36.2 months for the triplet control group (p < 0.001). Improved PFS was consistent across subgroups of patients including those with genetically high-risk disease. At the end of induction, the percentage of patients achieving at least a very good partial response was 82.3% in the KRdc group versus 58.9% in the control group (odds ratio 4.35, 95% CI 3.19-5.94, p < 0.001). Minimal residual disease negativity (cutoff 4 x 10.sup.-5 bone marrow leucocytes) was achieved in 55% of patients tested in the KRdc group at the end of induction, increasing to 75% of those tested after ASCT. The most common adverse events were haematological, with a low incidence of cardiac events. The trial continues to follow up patients to the co-primary endpoint of OS and for planned long-term follow-up analysis. Limitations of the study include a lack of blinding to treatment regimen and that the triplet control regimen did not include a proteasome inhibitor for all patients, which would be considered a current standard of care in many parts of the world. Conclusions The KRdc combination was well tolerated and was associated with both an increased percentage of patients achieving at least a very good partial response and a significant PFS benefit compared to immunomodulatory-agent-based triplet therapy. Trial registration ClinicalTrials.gov ISRCTN49407852., Author(s): Graham H. Jackson 1,*, Charlotte Pawlyn 2,3, David A. Cairns 4, Ruth M. de Tute 5, Anna Hockaday 4, Corinne Collett 4, John R. Jones 6, Bhuvan Kishore 7, [...]

Published
2021
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22. Second Primary Malignancy Incidence in Patients Receiving Lenalidomide at Induction and Maintenance; Long-Term Follow up of 4358 Patients Enrolled to the Myeloma XI Trial

Author

Jones, John R, primary, Cairns, David, additional, Menzies, Tom, additional, Pawlyn, Charlotte, additional, Davies, Faith E., additional, Sigsworth, Rachel, additional, Jenner, Matthew W, additional, Kaiser, Martin F., additional, Mottram, Rebecca, additional, Drayson, Mark T, additional, Gregory, Walter Martin, additional, Owen, Roger G, additional, Boyd, Kevin, additional, Cook, Gordon, additional, Jackson, Graham, additional, and Morgan, Gareth J., additional

Published
2022
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23. The Impact of Lymphocyte Composition in the Stem Cell Harvest on Blood Lymphocytes 1-2 Weeks Post-Autologous Stem Cell Transplant for Newly Diagnosed Myeloma

Author

Dimbleby, Benjamin, primary, Zhelezniakova, Tatiana, additional, Richter, Alex G, additional, Pawlyn, Charlotte, additional, Jones, John R, additional, Jenner, Matthew W, additional, Cairns, David, additional, Menzies, Tom, additional, Gregory, Walter Martin, additional, Kaiser, Martin F., additional, Cook, Gordon, additional, Owen, Roger G, additional, Jackson, Graham, additional, Davies, Faith E, additional, Morgan, Gareth J., additional, and Drayson, Mark T, additional

Published
2022
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24. Risk-Adapted Therapy Directed According to Response (RADAR, UK-MRA Myeloma XV) - Comparing MRD-Guided Treatment Escalation and De-Escalation Strategies in Patients with Newly Diagnosed Myeloma Suitable for Stem Cell Transplantation

Author

Yong, Kwee, primary, Royle, Kara-Louise, additional, Ramasamy, Karthik, additional, Parrish, Christopher, additional, Hockaday, Anna, additional, Asher, Samir, additional, Drayson, Mark T, additional, de Tute, Ruth M., additional, Jenner, Matthew W, additional, Kaiser, Martin F., additional, Pratt, Guy, additional, Sive, Jonathan, additional, Bygrave, Ceri, additional, Cook, Gordon, additional, Popat, Rakesh, additional, Smith, Dean, additional, Olivier, Catherine, additional, Barnard, Lorna, additional, Levinte, Doina, additional, Dawkins, Bryony, additional, Chapman, Michael A, additional, Chantry, Andrew D, additional, Jackson, Graham, additional, Quezada, Sergio A, additional, Owen, Roger G, additional, and Cairns, David, additional

Published
2022
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25. Extended Intensified Post-ASCT Consolidation with Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (Dara-VRd) for Ultra-High Risk (UHiR) Newly Diagnosed Myeloma (NDMM) and Primary Plasma Cell Leukemia (pPCL): The UK Optimum/Muknine Trial

Author

Kaiser, Martin F., primary, Hall, Andrew, additional, Smith, Isabelle, additional, de Tute, Ruth M., additional, Roberts, Sadie, additional, Ingleson, Emma, additional, Bowles, Kristian M, additional, Garg, Mamta, additional, Lokare, Anand, additional, Messiou, Christina, additional, Houlston, Richard S., additional, Jackson, Graham, additional, Cook, Gordon, additional, Pratt, Guy, additional, Drayson, Mark T, additional, Owen, Roger G, additional, Brown, Sarah R, additional, and Jenner, Matthew W, additional

Published
2022
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26. Defining the Optimal Duration of Lenalidomide Maintenance after Autologous Stem Cell Transplant - Data from the Myeloma XI Trial

Author

Pawlyn, Charlotte, primary, Menzies, Tom, additional, Davies, Faith E, additional, de Tute, Ruth M., additional, Henderson, Rowena, additional, Cook, Gordon, additional, Jenner, Matthew W, additional, Jones, John R, additional, Kaiser, Martin F., additional, Drayson, Mark T, additional, Owen, Roger G, additional, Cairns, David, additional, Morgan, Gareth J., additional, and Jackson, Graham, additional

Published
2022
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27. The Impact of Autologous Stem Cell Transplantation on the Genetics of High-Risk Relapsed Multiple Myeloma

Author

Shahin, Mohamed, primary, Pawlyn, Charlotte, additional, Weinhold, Niels, additional, Ashby, Timothy Cody, additional, Walker, Brian A., additional, Wardell, Christopher P., additional, Cairns, David, additional, Menzies, Tom, additional, Gregory, Walter Martin, additional, Kaiser, Martin F., additional, Cook, Gordon, additional, Drayson, Mark T, additional, Owen, Roger G, additional, Jackson, Graham, additional, Davies, Faith E, additional, Morgan, Gareth J., additional, and Jones, John R, additional

Published
2022
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28. SARS-CoV-2 Spike- and Nucleoprotein-Specific Antibodies Induced After Vaccination or Infection Promote Classical Complement Activation

Author

Lamerton, Rachel E., primary, Marcial-Juarez, Edith, additional, Faustini, Sian E., additional, Perez-Toledo, Marisol, additional, Goodall, Margaret, additional, Jossi, Siân E., additional, Newby, Maddy L., additional, Chapple, Iain, additional, Dietrich, Thomas, additional, Veenith, Tonny, additional, Shields, Adrian M., additional, Harper, Lorraine, additional, Henderson, Ian R., additional, Rayes, Julie, additional, Wraith, David C., additional, Watson, Steve P., additional, Crispin, Max, additional, Drayson, Mark T., additional, Richter, Alex G., additional, and Cunningham, Adam F., additional

Published
2022
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31. SARS‐CoV‐2‐specific IgG1/IgG3 but not IgM in children with Pediatric Inflammatory Multi‐System Syndrome

Author

Perez‐toledo, Marisol, Faustini, Sian E., Jossi, Sian E., Shields, Adrian M., Marcial‐juarez, Edith, Kanthimathinathan, Hari Krishnan, Allen, Joel D., Watanabe, Yasunori, Goodall, Margaret, Willcox, Benjamin E., Willcox, Carrie R., Salim, Mahboob, Wraith, David C., Veenith, Tonny V., Syrimi, Eleni, Drayson, Mark T., Jyothish, Deepthi, Al‐abadi, Eslam, Chikermane, Ashish, Welch, Steven B., Masilamani, Kavitha, Hackett, Scott, Crispin, Max, Scholefield, Barnaby R., Cunningham, Adam F., Richter, Alex G., and Genuneit, Jon

Subjects
2019-20 coronavirus outbreak, biology, Coronavirus disease 2019 (COVID-19), business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Immunology, medicine.disease, Virology, Immunoglobulin G, Systemic inflammatory response syndrome, Immunoglobulin M, Pediatrics, Perinatology and Child Health, biology.protein, Immunology and Allergy, Medicine, business, Letters to the Editor, Letter to the Editor
Abstract

During the COVID-19 outbreak, reports have surfaced of children who present with features of a multisystem inflammatory syndrome with overlapping features of Kawasaki disease and toxic shock syndrome - Paediatric Inflammatory Multisystem Syndrome- temporally associated with SARS-CoV-2 pandemic (PIMS-TS). Initial reports find that many of the children are PCR-negative for SARS-CoV-2, so it is difficult to confirm whether this syndrome is a late complication of viral infection in an age group largely spared the worst consequences of this infection, or if this syndrome reflects enhanced surveillance.Children hospitalised for symptoms consistent with PIMS-TS between 28 April and 8 May 2020, and who were PCR-negative for SARS-CoV-2, were tested for antibodies to viral spike glycoprotein using an ELISA test.Eight patients (age range 7-14 years, 63% male) fulfilled case-definition for PIMS-TS during the study period. Six of the eight patients required admission to intensive care. All patients exhibited significant IgG and IgA responses to viral spike glycoprotein. Further assessment showed that the IgG isotypes detected in children with PIMS-TS were of the IgG1 and IgG3 subclasses, a distribution similar to that observed in samples from hospitalised adult COVID-19 patients. In contrast, IgG2 and IgG4 were not detected in children or adults. IgM was not detected in children, which contrasts with adult hospitalised adult COVID-19 patients of whom all had positive IgM responses.Strong IgG antibody responses can be detected in PCR-negative children with PIMS-TS. The low detection rate of IgM in these patients is consistent with infection having occurred weeks previously and that the syndrome onset occurs well after the control of SARS-CoV-2 viral load. This implies that the disease is largely immune-mediated. Lastly, this indicates that serology can be an appropriate diagnostic tool in select patient groups.

Published
2021

32. Deep immune B and plasma cell repertoire in non-small cell lung cancer.

Author

Patel, Akshay J., Khan, Naeem, Richter, Alex, Naidu, Babu, Drayson, Mark T., and Middleton, Gary W.

Subjects
NON-small-cell lung carcinoma, PLASMA cells, B cells, REGULATORY B cells, SQUAMOUS cell carcinoma
Abstract

Introduction: B cells, which have long been thought to be minor players in the development of anti-tumor responses, have been implicated as key players in lung cancer pathogenesis and response to checkpoint blockade in patients with lung cancer. Enrichment of late-stage plasma and memory cells in the tumor microenvironment has been shown in lung cancer, with the plasma cell repertoire existing on a functional spectrum with suppressive phenotypes correlating with outcome. B cell dynamics may be influenced by the inflammatory microenvironment observed in smokers and between LUAD and LUSC. Methods: Here, we show through high-dimensional deep phenotyping using mass cytometry (CyTOF), next generation RNA sequencing and multispectral immunofluorescence imaging (VECTRA Polaris) that key differences exist in the B cell repertoire between tumor and circulation in paired specimens from lung adenocarcinoma (LUAD) and squamous cell carcinoma (LUSC). Results: In addition to the current literature, this study provides insight into the in-depth description of the B cell contexture in Non-Small Cell Lung Cancer (NSCLC) with reference to broad clinico-pathological parameters based on our analysis of 56 patients. Our findings reinforce the phenomenon of B-cell trafficking from distant circulatory compartments into the tumour microenvironment (TME). The circulatory repertoire shows a predilection toward plasma and memory phenotypes in LUAD however no major differences exist between LUAD and LUSC at the level of the TME. B cell repertoire, amongst other factors, may be influenced by the inflammatory burden in the TME and circulation, that is, smokers and non-smokers. We have further clearly demonstrated that the plasma cell repertoire exists on a functional spectrum in lung cancer, and that the suppressive regulatory arm of this axis may play a significant role in determining postoperative outcomes as well as following checkpoint blockade. This will require further long-term functional correlation. Conclusion: B and Plasma cell repertoire is very diverse and heterogeneous across different tissue compartments in lung cancer. Smoking status associates with key differences in the immune milieu and the consequent inflammatory microenvironment is likely responsible for the functional and phenotypic spectrum we have seen in the plasma cell and B cell repertoire in this condition. [ABSTRACT FROM AUTHOR]

Published
2023
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34. 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

Author

Striha, Alina, Ashcroft, A. John, Hockaday, Anna, Cairns, David A., Boardman, Karen, Jacques, Gwen, Williams, Cathy, Snowden, John A., Garg, Mamta, Cavenagh, Jamie, Yong, Kwee, Drayson, Mark T., Owen, Roger, Cook, Mark, and Cook, Gordon

Published
2018
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39. Dysregulated Humoral Immunity to Nontyphoidal Salmonella in HIV-Infected African Adults

Author

MacLennan, Calman A., Gilchrist, James J., Gordon, Melita A., Cunningham, Adam F., Cobbold, Mark, Goodall, Margaret, Kingsley, Robert A., van Oosterhout, Joep J. G., Msefula, Chisomo L., Mandala, Wilson L., Leyton, Denisse L., Marshall, Jennifer L., Gondwe, Esther N., Bobat, Saeeda, López-Macías, Constantino, Doffinger, Rainer, Henderson, Ian R., Zijlstra, Eduard E., Dougan, Gordon, Drayson, Mark T., MacLennan, Ian C. M., and Molyneux, Malcolm E.

Published
2010

41. Response-adapted intensification with cyclophosphamide, bortezomib, and dexamethasone versus no intensification in patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial

Author

Jackson, Graham H, Davies, Faith E, Pawlyn, Charlotte, Cairns, David A, Striha, Alina, Collett, Corinne, Waterhouse, Anna, Jones, John R, Kishore, Bhuvan, Garg, Mamta, Williams, Cathy D, Karunanithi, Kamaraj, Lindsay, Jindriska, Wilson, Jamie N, Jenner, Matthew W, Cook, Gordon, Kaiser, Martin F, Drayson, Mark T, Owen, Roger G, Russell, Nigel H, Gregory, Walter M, and Morgan, Gareth J

Subjects
Male, Dose-Response Relationship, Drug, Middle Aged, Survival Analysis, Article, Dexamethasone, Neoadjuvant Therapy, United Kingdom, Bortezomib, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols, Humans, Female, Drug Monitoring, Multiple Myeloma, Cyclophosphamide, Aged
Abstract

Summary Background Multiple myeloma has been shown to have substantial clonal heterogeneity, suggesting that agents with different mechanisms of action might be required to induce deep responses and improve outcomes. Such agents could be given in combination or in sequence on the basis of previous response. We aimed to assess the clinical value of maximising responses by using therapeutic agents with different modes of action, the use of which is directed by the response to the initial combination therapy. We aimed to assess response-adapted intensification treatment with cyclophosphamide, bortezomib, and dexamethasone (CVD) versus no intensification treatment in patients with newly diagnosed multiple myeloma who had a suboptimal response to initial immunomodulatory triplet treatment which was standard of care in the UK at the time of trial design. Methods The Myeloma XI trial was an open-label, randomised, phase 3, adaptive design trial done at 110 National Health Service hospitals in the UK. There were three potential randomisations in the study: induction treatment, intensification treatment, and maintenance treatment. Here, we report the results of the randomisation to intensification treatment. Eligible patients were aged 18 years or older and had symptomatic or non-secretory, newly diagnosed multiple myeloma, had completed their assigned induction therapy as per protocol (cyclophosphamide, thalidomide, and dexamethasone or cyclophosphamide, lenalidomide, and dexamethasone) and achieved a partial or minimal response. For the intensification treatment, patients were randomly assigned (1:1) to cyclophosphamide (500 mg daily orally on days 1, 8, and 15), bortezomib (1·3 mg/m2 subcutaneously or intravenously on days 1, 4, 8, and 11), and dexamethasone (20 mg daily orally on days 1, 2, 4, 5, 8, 9, 11, and 12) up to a maximum of eight cycles of 21 days or no treatment. Patients were stratified by allocated induction treatment, response to induction treatment, and centre. The co-primary endpoints were progression-free survival and overall survival, assessed from intensification randomisation to data cutoff, analysed by intention to treat. Safety analysis was per protocol. This study is registered with the ISRCTN registry, number ISRCTN49407852, and clinicaltrialsregister.eu, number 2009–010956–93, and has completed recruitment. Findings Between Nov 15, 2010, and July 28, 2016, 583 patients were enrolled to the intensification randomisation, representing 48% of the 1217 patients who achieved partial or minimal response after initial induction therapy. 289 patients were assigned to CVD treatment and 294 patients to no treatment. After a median follow-up of 29·7 months (IQR 17·0–43·5), median progression-free survival was 30 months (95% CI 25–36) with CVD and 20 months (15–28) with no CVD (hazard ratio [HR] 0·60, 95% CI 0·48–0·75, p

Published
2019

45. SARS-CoV-2 vaccine responses following CD20-depletion treatment in patients with haematological and rheumatological disease: a West Midlands Research Consortium study

Author

Shields, Adrian M, primary, Venkatachalam, Srinivasan, additional, Shafeek, Salim, additional, Paneesha, Shankara, additional, Ford, Mark, additional, Sheeran, Tom, additional, Kelly, Melanie, additional, Qureshi, Iman, additional, Salhan, Beena, additional, Karim, Farheen, additional, De Silva, Neelakshi, additional, Stones, Jacqueline, additional, Lee, Sophie, additional, Khawaja, Jahanzeb, additional, Kaudlay, Praveen Kumar, additional, Whitmill, Richard, additional, Kakepoto, Ghulam Nabi, additional, Parry, Helen M, additional, Moss, Paul, additional, Faustini, Sian E, additional, Richter, Alex G, additional, Drayson, Mark T, additional, and Basu, Supratik, additional

Published
2021
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46. Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, Dexamethasone (Dara-CVRd), V-Augmented Autologous Stem Cell Transplant (V-ASCT) and Dara-Vrd Consolidation in Ultra-High Risk (UHiR) Newly Diagnosed Myeloma (NDMM) and Primary Plasma Cell Leukemia (pPCL) Compared with Myeloma XI/XI+ Trial Treatment for Uhir MM: The UK Optimum/Muknine Trial

Author

Kaiser, Martin F., primary, Hall, Andrew, additional, Walker, Katrina, additional, Newnham, Nicola, additional, de Tute, Ruth M., additional, Roberts, Sadie, additional, Ingleson, Emma, additional, Bowles, Kristian M, additional, Garg, Mamta, additional, Lokare, Anand, additional, Messiou, Christina, additional, Jackson, Graham, additional, Cook, Gordon, additional, Pratt, Guy, additional, Owen, Roger G, additional, Drayson, Mark T, additional, Brown, Sarah R, additional, and Jenner, Matthew W, additional

Published
2021
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47. Residual Monoclonal Free Light Chain Positivity By Mass Spectrometry Identifies Patients at Increased Risk of Early Relapse Following First-Line Anti-Myeloma Treatment

Author

Giles, Hannah Victoria, primary, Drayson, Mark T, additional, Wright, Nicola, additional, Cook, Gordon, additional, Davies, Faith E., additional, Morgan, Gareth J, additional, de Tute, Ruth M., additional, Owen, Roger G, additional, Cairns, David, additional, Hockaday, Anna, additional, Menzies, Tom, additional, Kaiser, Martin F., additional, Pawlyn, Charlotte, additional, Jackson, Graham, additional, and Pratt, Guy, additional

Published
2021
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48. Fitness, a UK Myeloma Research Alliance (UK-MRA) Frailty-Adjusted Therapy Study, Supports the Feasibility of Recruiting Frail Newly Diagnosed Myeloma Patients to Large Clinical Trials

Author

Cook, Gordon, primary, Pawlyn, Charlotte, additional, Royle, Kara-Louise, additional, Coulson, Amy Beth, additional, Bird, Jennifer, additional, Bowcock, Stella, additional, Jenner, Matthew W, additional, Kishore, Bhuvan, additional, Parrish, Christopher, additional, Rabin, Neil K, additional, Best, Phillip, additional, Gillson, Sharon, additional, Henderson, Rowena, additional, Olivier, Catherine, additional, Kaiser, Martin F., additional, de Tute, Ruth M., additional, Owen, Roger G, additional, Drayson, Mark T, additional, Jones, John R, additional, Dawkins, Bryony, additional, Meads, David, additional, Cairns, David, additional, and Jackson, Graham, additional

Published
2021
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49. Multistate Models Demonstrate That Lenalidomide Maintenance Enhances Survival By Prolonging Time in First Remission for Patients Treated in the UK NCRI Myeloma XI Randomised Trial

Author

Craig, Zoe, primary, Parrish, Christopher, additional, Pawlyn, Charlotte, additional, Kaiser, Martin F., additional, Olivier, Catherine, additional, Jones, John R, additional, Drayson, Mark T, additional, Owen, Roger G, additional, Jenner, Matthew W, additional, Cook, Gordon, additional, Gregory, Walter Martin, additional, Davies, Faith E, additional, Morgan, Gareth J., additional, Jackson, Graham, additional, and Cairns, David, additional

Published
2021
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50. Vaccine Efficacy after Rituximab Exposure: First Interim Analysis of Virtue Project on Behalf of West Midlands Research Consortium, UK

Author

Shields, Adrian M, primary, Venkatachalam, Srinivasan, additional, Paneesha, Shankara, additional, Ford, Mark, additional, Sheeran, Tom, additional, Kelly, Melanie, additional, Karim, Farheen, additional, Qureshi, Iman, additional, Salhan, Beena, additional, DeSilva, Neelakshi, additional, Stones, Jacqueline, additional, Lee, Sophie, additional, Khawaja, Jahanzeb, additional, Kaudlay, Praveen Kumar, additional, Whitmill, Richard, additional, Nabikakepoto, Ghulam, additional, Faustini, Sian E, additional, Richter, Alex G, additional, Drayson, Mark T, additional, and Basu, Supratik, additional

Published
2021
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