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1. 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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2. Copy number evolution and its relationship with patient outcome—an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial

Author

Croft, James, Ellis, Sidra, Sherborne, Amy L., Sharp, Kim, Price, Amy, Jenner, Matthew W., Drayson, Mark T., Owen, Roger G., Chown, Sally, Lindsay, Jindriska, Karunanithi, Kamaraj, Hunter, Hannah, Gregory, Walter M., Davies, Faith E., Morgan, Gareth J., Cook, Gordon, Atanesyan, Lilit, Savola, Suvi, Cairns, David A., Jackson, Graham, Houlston, Richard S., and Kaiser, Martin F.

Published
2021
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3. 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

Published
2019
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4. Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS)

Author

Landgren, C. Ola, Chari, Ajai, Cohen, Yael C., Spencer, Andrew, Voorhees, Peter, Estell, Jane A., Sandhu, Irwindeep, Jenner, Matthew W., Williams, Catherine, Cavo, Michele, van de Donk, Niels W. C. J., Beksac, Meral, Moreau, Philippe, Goldschmidt, Hartmut, Kuppens, Steven, Bandekar, Rajesh, Clemens, Pamela L., Neff, Tobias, Heuck, Christoph, Qi, Ming, and Hofmeister, Craig C.

Published
2020
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5. Real-world effectiveness and safety of ixazomib-lenalidomide-dexamethasone in relapsed/refractory multiple myeloma

Author

Terpos, Evangelos, Ramasamy, Karthik, Maouche, Nadjoua, Minarik, Jiri, Ntanasis-Stathopoulos, Ioannis, Katodritou, Eirini, Jenner, Matthew W., Plonkova, Hana, Gavriatopoulou, Maria, Vallance, Grant D., Pika, Tomas, Kotsopoulou, Maria, Kothari, Jaimal, Jelinek, Tomas, Kastritis, Efstathios, Aitchison, Robin, Dimopoulos, Meletios A., Zomas, Athanasios, and Hajek, Roman

Published
2020
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6. Daratumumab, Cyclophosphamide, Bortezomib, Lenalidomide, and Dexamethasone as Induction and Extended Consolidation Improves Outcome in Ultra-High-Risk Multiple Myeloma

Author

Kaiser, Martin F., primary, Hall, Andrew, additional, Walker, Katrina, additional, Sherborne, Amy, additional, De Tute, Ruth M., additional, Newnham, Nicola, additional, Roberts, Sadie, additional, Ingleson, Emma, additional, Bowles, Kristian, additional, Garg, Mamta, additional, Lokare, Anand, additional, Messiou, Christina, additional, Houlston, Richard S., 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
2023
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7. Data from Homozygous Deletion Mapping in Myeloma Samples Identifies Genes and an Expression Signature Relevant to Pathogenesis and Outcome

Author

Dickens, Nicholas J., primary, Walker, Brian A., primary, Leone, Paola E., primary, Johnson, David C., primary, Brito, José L., primary, Zeisig, Athanasia, primary, Jenner, Matthew W., primary, Boyd, Kevin D., primary, Gonzalez, David, primary, Gregory, Walter M., primary, Ross, Fiona M., primary, Davies, Faith E., primary, and Morgan, Gareth J., primary

Published
2023
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8. Adobe PDF - Supplementary_Data.pdf from Homozygous Deletion Mapping in Myeloma Samples Identifies Genes and an Expression Signature Relevant to Pathogenesis and Outcome

Author

Dickens, Nicholas J., primary, Walker, Brian A., primary, Leone, Paola E., primary, Johnson, David C., primary, Brito, José L., primary, Zeisig, Athanasia, primary, Jenner, Matthew W., primary, Boyd, Kevin D., primary, Gonzalez, David, primary, Gregory, Walter M., primary, Ross, Fiona M., primary, Davies, Faith E., primary, and Morgan, Gareth J., primary

Published
2023
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9. 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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10. 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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11. 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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12. 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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13. 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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14. 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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15. Minimal Residual Disease After Autologous Stem-Cell Transplant for Patients With Myeloma: Prognostic Significance and the Impact of Lenalidomide Maintenance and Molecular Risk

Author

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

Published
2022
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16. Immune responses to COVID‐19 booster vaccinations in intensively anti‐CD38 antibody treated patients with ultra‐high‐risk multiple myeloma: results from the Myeloma UK (MUK) nine OPTIMUM trial.

Author

Faustini, Sian E., Hall, Andrew, Brown, Sarah, Roberts, Sadie, Hill, Harriet, Stamataki, Zania, Jenner, Matthew W., Owen, Roger G., Pratt, Guy, Cook, Gordon, Richter, Alex, Drayson, Mark T., Kaiser, Martin F., and Heaney, Jennifer L. J.

Subjects
COVID-19 pandemic, BOOSTER vaccines, MULTIPLE myeloma, COVID-19, SARS-CoV-2
Abstract

Summary: Multiple myeloma (MM) and anti‐MM therapy cause profound immunosuppression, leaving patients vulnerable to coronavirus disease 2019 (COVID‐19) and other infections. We investigated anti‐severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) antibodies longitudinally in ultra‐high‐risk patients with MM receiving risk‐adapted, intensive anti‐CD38 combined therapy in the Myeloma UK (MUK) nine trial. Despite continuous intensive therapy, seroconversion was achieved in all patients, but required a greater number of vaccinations compared to healthy individuals, highlighting the importance of booster vaccinations in this population. Reassuringly, high antibody cross‐reactivity was found with current variants of concern, prior to Omicron subvariant adapted boostering. Multiple booster vaccine doses can provide effective protection from COVID‐19, even with intensive anti‐CD38 therapy for high‐risk MM. [ABSTRACT FROM AUTHOR]

Published
2023
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17. The addition of vorinostat to lenalidomide maintenance for patients with newly diagnosed multiple myeloma of all ages: results from 'Myeloma XI', a multicentre, open‐label, randomised, phase III trial.

Author

Jenner, Matthew W., Pawlyn, Charlotte, Davies, Faith E., Menzies, Tom, Hockaday, Anna, Olivier, Catherine, Jones, John R., Karunanithi, Kamaraj, Lindsay, Jindriska, Kishore, Bhuvan, Cook, Gordon, Drayson, Mark T., Kaiser, Martin F., Owen, Roger G., Gregory, Walter, Cairns, David A., Morgan, Gareth J., and Jackson, Graham H.

Subjects
*CLINICAL trials, *LENALIDOMIDE, *MULTIPLE myeloma, *HISTONE deacetylase inhibitors, *PLASMACYTOMA, *PROGRESSION-free survival
Abstract

Summary: Lenalidomide is an effective maintenance agent for patients with myeloma, prolonging first remission and, in transplant eligible patients, improving overall survival (OS) compared to observation. The 'Myeloma XI' trial, for newly diagnosed patients, aimed to evaluate whether the addition of the histone deacetylase inhibitor vorinostat to the lenalidomide maintenance backbone could improve outcomes further. Patients included in this analysis were randomised to maintenance therapy with lenalidomide alone (10 mg/day on days 1–21 of each 28‐day cycle), or in combination with vorinostat (300 mg/day on day 1–7 and 15–21 of each 28‐day cycle) with treatment continuing until unacceptable toxicity or progressive disease. There was no significant difference in median progression‐free survival between those receiving lenalidomide‐vorinostat or lenalidomide alone, 34 and 40 months respectively (hazard ratio [HR] 1.18, 95% confidence interval [CI] 0.96–1.44, p = 0.109). There was also no significant difference in median OS, not estimable and 75 months respectively (HR 0.99, 95% CI 0.76–1.29, p = 0.929). Subgroup analysis demonstrated no statistically significant heterogeneity in outcomes. Combination lenalidomide‐vorinostat appeared to be poorly tolerated with more dose modifications, fewer cycles of maintenance therapy delivered and higher rates of discontinuation due to toxicity than lenalidomide alone. The trial did not meet its primary end‐point, there was no benefit from the addition of vorinostat to lenalidomide maintenance. [ABSTRACT FROM AUTHOR]

Published
2023
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19. 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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20. Karyosequencing: Integrating Genome-Wide and Targeted Sequencing for Comprehensive Diagnosis of Lymphoproliferative Disorders

Author

Stewart, James Peter, primary, Harewood, Louise, additional, Srivastava, Shambhavi, additional, Gazdova, Jana, additional, Maurya, Manisha, additional, Nakjang, Sirintra, additional, Hodges, Elizabeth, additional, Chiecchio, Laura, additional, Cross, Nicholas C.P., additional, Jenner, Matthew W, additional, Catherwood, Mark, additional, Ryan, Sarra, additional, Moorman, Anthony V., additional, Darzentas, Nikos, additional, and Gonzalez, David, additional

Published
2021
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21. 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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22. 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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23. Phenotypic High-Risk Disease in the Context of Carfilzomib and Lenalidomide Combination Induction Therapy for Newly Diagnosed Transplant-Eligible Myeloma Patients

Author

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

Published
2021
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24. Response to COVID-19 Vaccines in Patients Receiving Intensified Post-ASCT Therapy with Daratumumab, Lenalidomide, Bortezomib (Dara-VR) Due to Ultra-High Risk (UHiR) Newly Diagnosed Myeloma (NDMM) or Primary Plasma Cell Leukemia (pPCL): Exploratory Analysis of the UK Optimum/Muknine Trial

Author

Jenner, Matthew W, primary, Hall, Andrew, additional, Faustini, Sian E, additional, Pitchford, Alexandra, 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, Pratt, Guy, additional, Cook, Gordon, additional, Owen, Roger G, additional, Brown, Sarah R, additional, Drayson, Mark T, additional, and Kaiser, Martin F., additional

Published
2021
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26. High Success Rates Utilizing Local Standard of Care Cytogenetic Testing for Risk Stratified Frontline Therapy for Newly Diagnosed Multiple Myeloma: Experience from the Ukmra RADAR Study

Author

Mehta, Dipal, Chiecchio, Laura, Kaiser, Martin F., Gooding, Sarah, Royle, Kara-Louise, Levinte, Doina, Olivier, Catherine, Cairns, David Allan, Barnard, Lorna, Jackson, Sharon, Cicero, Robert, Cook, Gordon, Chapman, Michael A., Chant, Alan, Meads, David, Dawkins, Bryony, Pratt, Guy, Popat, Rakesh, Jackson, Graham, Bygrave, Ceri, Chantry, Andrew, Sive, Jonathan, Parrish, Christopher, Smith, Dean, Drayson, Mark, Owen, Roger, de Tute, Ruth M, Ramasamy, Karthik, Yong, Kwee, and Jenner, Matthew W.

Published
2023
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27. The Addition of Carfilzomib to a Lenalidomide-Based Triplet Improves Outcomes in Newly Diagnosed Transplant Eligible Myeloma Patients with Renal Impairment: A Subgroup Analysis of the Myeloma XI Trial

Author

Pawlyn, Charlotte, Menzies, Tom, Davies, Faith E., Rana, Ritika, Pinney, Jennifer, Cook, Gordon, Gregory, Walter Martin, Jenner, Matthew W, Jones, John R, Kaiser, Martin F., Owen, Roger G, Morgan, Gareth, Jackson, Graham H, Cairns, David, and Drayson, Mark T

Published
2020
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29. Thrombosis in Patients with Myeloma Treated in the Myeloma IX and Myeloma XI Phase III Randomized Controlled Trials

Author

Bradbury, Charlotte A, Craig, Zoe, Cook, Gordon, Pawlyn, Charlotte, Cairns, David A, Hockaday, Anna, Paterson, Andrea, Jenner, Matthew W, Jones, John Robert, Drayson, Mark Trehane, Owen, Roger G, Kaiser, Martin F, Gregory, Walter Martin, Davies, Faith E, Child, James Anthony, Morgan, Gareth J, and Jackson, Graham

Subjects
hemostasis, thrombosis
Abstract

Newly diagnosed multiple myeloma (NDMM) patients treated with immunomodulatory drugs (IMiDs) are at high venous thrombosis (VTE) risk, but data are lacking from large prospective cohorts. We present thrombosis outcome data from Myeloma IX (n=1936) and Myeloma XI (n=4358), phase III randomized controlled trials for NDMM, treating transplant-eligible and ineligible patients before and after publication of thrombosis prevention guidelines. In Myeloma IX, compared to CTD (cyclophosphamide, thalidomide and dexamethasone), transplant-eligible patients randomized to CVAD induction (cyclophosphamide, vincristine, doxorubicin and dexamethasone) had higher VTE risk (22.5%(n=121/538) vs 16.1%(n=89/554), aHR:1.46,95%CI:1.11-1.93). For transplant-ineligible patients, compared to MP (melphalan and prednisolone), patients randomized to CTDa (attenuated CTD) induction had higher VTE risk (16.0%(n=68/425) vs 4.1%(n=17/419), aHR:4.25,95%CI:2.50-7.20). In Myeloma XI, there was no difference in VTE or arterial thrombosis risk between transplant-eligible pathways, CRD (cyclophosphamide, lenalidomide and dexamethasone) and CTD (VTE:12.2%(n=124/1014) vs 13.2%(n=133/1008), aHR:0.92,95%CI:0.72-1.18; arterial events:1.2%(n=12/1014) vs 1.5%(n=15/1008), aHR:0.80,95%CI:0.37-1.70). For transplant-ineligible patients, there was no difference in VTEs between CRDa (attenuated CRD) and CTDa (10.4%(n=95/916) vs 10.7%(n=97/910), aHR:0.97, 95%CI:0.73-1.29). However, arterial risk was higher with CRDa than CTDa (3.1%(n=28/916) vs 1.6%(n=15/910), aHR:1.91,95%CI:1.02-3.57). Thrombotic events occurred almost entirely within 6m of treatment initiation. Thrombosis was not associated with inferior progression-free or overall survival (OS), apart from inferior OS for patients with arterial events (aHR:1.53, 95%CI:1.12-2.08) in Myeloma XI. The Myeloma XI trial protocol incorporated IMWG thrombosis prevention recommendations and compared to Myeloma IX, more patients were on thromboprophylaxis (80.5% vs 22.3%) with lower VTE rates for identical regimens (CTD:13.2% vs 16.1%, CTDa:10.7% vs 16.0%). However, thrombosis remained frequent in spite of IMWG-guided thromboprophylaxis, suggesting new approaches are needed.

Published
2020

31. Ixazomib, lenalidomide, and dexamethasone is effective and well tolerated in multiply relapsed (≥2nd relapse) refractory myeloma: a multicenter real world UK experience

Author

Maouche, Nadjoua, primary, Kishore, Bhuvan, additional, Jenner, Matthew W., additional, Boyd, Kevin, additional, Bhatti, Zara, additional, Bird, Sarah Anne, additional, Chander, Gurvin, additional, Robinson, Rebecca, additional, Vallance, Grant D., additional, Offer, Mark, additional, Kothari, Jaimal, additional, Peniket, Andy, additional, Aitchison, Robin, additional, Dungarwalla, Moez, additional, Collings, Freya, additional, Bygrave, Ceri, additional, and Ramasamy, Karthik, additional

Published
2020
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32. Copy number evolution and its relationship with patient outcome—an analysis of 178 matched presentation-relapse tumor pairs from the Myeloma XI trial

Author

Croft, James, primary, Ellis, Sidra, additional, Sherborne, Amy L., additional, Sharp, Kim, additional, Price, Amy, additional, Jenner, Matthew W., additional, Drayson, Mark T., additional, Owen, Roger G., additional, Chown, Sally, additional, Lindsay, Jindriska, additional, Karunanithi, Kamaraj, additional, Hunter, Hannah, additional, Gregory, Walter M., additional, Davies, Faith E., additional, Morgan, Gareth J., additional, Cook, Gordon, additional, Atanesyan, Lilit, additional, Savola, Suvi, additional, Cairns, David A., additional, Jackson, Graham, additional, Houlston, Richard S., additional, and Kaiser, Martin F., additional

Published
2020
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34. Thrombosis in patients with myeloma treated in the Myeloma IX and Myeloma XI phase 3 randomized controlled trials

Author

Bradbury, Charlotte A., primary, Craig, Zoe, additional, Cook, Gordon, additional, Pawlyn, Charlotte, additional, Cairns, David A., additional, Hockaday, Anna, additional, Paterson, Andrea, additional, Jenner, Matthew W., additional, Jones, John R., additional, Drayson, Mark T., additional, Owen, Roger G., additional, Kaiser, Martin F., additional, Gregory, Walter M., additional, Davies, Faith E., additional, Child, J. Anthony, additional, Morgan, Gareth J., additional, and Jackson, Graham H., additional

Published
2020
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37. Subclonal TP53 copy number is associated with prognosis in multiple myeloma

Author

Shah, Vallari, Johnson, David C., Sherborne, Amy L., Ellis, Sidra, Aldridge, Frances M., Howard-Reeves, Julie, Begum, Farzana, Price, Amy, Kendall, Jack, Chiecchio, Laura, Savola, Suvi, Jenner, Matthew W., Drayson, Mark T., Owen, Roger G., Gregory, Walter M., Morgan, Gareth J., Davies, Faith E., Houlston, Richard S., Cook, Gordon, Cairns, David A., Jackson, Graham, and Kaiser, Martin F.

Published
2018
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38. Ixazomib, lenalidomide, and dexamethasone is effective and well tolerated in multiply relapsed (≥2nd relapse) refractory myeloma: a multicenter real world UK experience.

Author

Maouche, Nadjoua, Kishore, Bhuvan, Jenner, Matthew W., Boyd, Kevin, Bhatti, Zara, Bird, Sarah Anne, Chander, Gurvin, Robinson, Rebecca, Vallance, Grant D., Offer, Mark, Kothari, Jaimal, Peniket, Andy, Aitchison, Robin, Dungarwalla, Moez, Collings, Freya, Bygrave, Ceri, and Ramasamy, Karthik

Subjects
OVERALL survival, DEXAMETHASONE, PROTEASOME inhibitors, PROGRESSION-free survival, MULTIPLE myeloma, LENALIDOMIDE
Abstract

There are limited real world data on ixazomib, lenalidomide, and dexamethasone (IRd) in multiply relapsed myeloma. We analyzed outcomes of 116 patients who received IRd predominantly at second and subsequent relapse including those refractory to proteasome inhibitors (PIs). With a median follow up 16.3 months, the overall response rate was 66.9%; median progression-free survival (PFS) was 17.7 months with median overall survival (OS) not reached (NR). PFS and OS were significantly shorter in advanced disease (PFS; 12.6 vs. 21.2 months (p =.01), OS; 15.9 months vs. NR (p =.01) for ISS3 vs. ISS 1&2, respectively). PFS and OS were significantly shorter in clinical high risk (CHR) compared to standard risk (SR) patients (PFS; 9.3 months vs. NR (p =.001), OS; 11.5 months vs. NR (p <.001), respectively). There was a trend toward shorter PFS in PI-refractory patients 13.7 vs. 19.6 months for non-PI refractory (p =.2). The triplet combination was generally well tolerated. [ABSTRACT FROM AUTHOR]

Published
2021
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39. Lenalidomide maintenance versus observation for 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, Hockaday, Anna, Jones, John R, Kishore, Bhuvan, Garg, Mamta, Williams, Cathy D, Karunanithi, Kamaraj, Lindsay, Jindriska, Jenner, Matthew W, Cook, Gordon, Russell, Nigel H, Kaiser, Martin F, Drayson, Mark T, Owen, Roger G, Gregory, Walter M, and Morgan, Gareth J

Subjects
Treatment Outcome, Hematopoietic Stem Cell Transplantation, Humans, Multiple Myeloma, Lenalidomide, Transplantation, Autologous, Article, Progression-Free Survival, Thalidomide, Intention to Treat Analysis, Maintenance Chemotherapy
Abstract

Summary Background Patients with multiple myeloma treated with lenalidomide maintenance therapy have improved progression-free survival, primarily following autologous stem-cell transplantation. A beneficial effect of lenalidomide maintenance therapy on overall survival in this setting has been inconsistent between individual studies. Minimal data are available on the effect of maintenance lenalidomide in more aggressive disease states, such as patients with cytogenetic high-risk disease or patients ineligible for transplantation. We aimed to assess lenalidomide maintenance versus observation in patients with newly diagnosed multiple myeloma, including cytogenetic risk and transplantation status subgroup analyses. Methods The Myeloma XI trial was an open-label, randomised, phase 3, adaptive design trial with three randomisation stages done at 110 National Health Service hospitals in England, Wales, and Scotland. There were three potential randomisations in the study: induction treatment (allocation by transplantation eligibility status); intensification treatment (allocation by response to induction therapy); and maintenance treatment. Here, we report the results of the randomisation to maintenance treatment. Eligible patients for maintenance randomisation were aged 18 years or older and had symptomatic or non-secretory multiple myeloma, had completed their assigned induction therapy as per protocol and had achieved at least a minimal response to protocol treatment, including lenalidomide. Patients were randomly assigned (1:1 from Jan 13, 2011, to Jun 27, 2013, and 2:1 from Jun 28, 2013, to Aug 11, 2017) to lenalidomide maintenance (10 mg orally on days 1–21 of a 28-day cycle) or observation, and stratified by allocated induction and intensification treatment, and centre. The co-primary endpoints were progression-free survival and overall survival, 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 Jan 13, 2011, and Aug 11, 2017, 1917 patients were accrued to the maintenance treatment randomisation of the trial. 1137 patients were assigned to lenalidomide maintenance and 834 patients to observation. After a median follow-up of 31 months (IQR 18–50), median progression-free survival was 39 months (95% CI 36–42) with lenalidomide and 20 months (18–22) with observation (hazard ratio [HR] 0·46 [95% CI 0·41–0·53]; p

Published
2018

41. Pomalidomide plus Bortezomib plus Low-Dose Dexamethasone Vs Bortezomib plus Low-Dose Dexamethasone As Second-Line Treatment in Patients with Lenalidomide-Pretreated Multiple Myeloma: A Subgroup Analysis of the Phase 3 Optimismm Trial

Author

Dimopoulos, Meletios A. Weisel, Katja Moreau, Philippe and Anderson, Larry White, Darrell J. San-Miguel, Jesus F. and Sonneveld, Pieter Engelhardt, Monika Jenner, Matthew W. and Corso, Alessandro Duerig, Jan Pavic, Michel Salomo, Morten and Yu, Xin Tuong Vi Nguyen Bensmaine, Amine Peluso, Teresa and Zaki, Mohamed Richardson, Paul

Published
2018

42. Lenalidomide maintenance versus observation for patients with newly diagnosed multiple myeloma (Myeloma XI): a multicentre, open-label, randomised, phase 3 trial

Author

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

Published
2019
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43. Progression Free Survival below 12 Months Following Stem Cell Transplant Is a Hallmark of High-Risk Myeloma Which Is Associated with Inferior Overall Survival — Data from the Ukmrc Myeloma XI Trial

Author

Bygrave, Ceri A, primary, Pawlyn, Charlotte, additional, Davies, Faith E., additional, Cairns, David, additional, Striha, Alina, additional, Hockaday, Anna, additional, Paterson, Andrea, additional, Jones, John R, additional, Kishore, Bhuvan, additional, Garg, Mamta, additional, Williams, Cathy, additional, Karunanithi, Kamaraj, additional, Lindsay, Jindriska, additional, Jenner, Matthew W, additional, Cook, Gordon, additional, Drayson, Mark T, additional, Owen, Roger G., additional, Russel, Nigel H, additional, Gregory, Walter M, additional, Morgan, Gareth J., additional, Jackson, Graham, additional, and Kaiser, Martin, additional

Published
2018
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44. Pomalidomide + Bortezomib + Low-Dose Dexamethasone Vs Bortezomib + Low-Dose Dexamethasone As Second-Line Treatment in Patients with Lenalidomide-Pretreated Multiple Myeloma: A Subgroup Analysis of the Phase 3 Optimismm Trial

Author

Dimopoulos, Meletios A, primary, Weisel, Katja, additional, Moreau, Philippe, additional, Anderson, Larry, additional, White, Darrell J, additional, San-Miguel, Jesus F, additional, Sonneveld, Pieter, additional, Engelhardt, Monika, additional, Jenner, Matthew W, additional, Corso, Alessandro, additional, Dürig, Jan, additional, Pavic, Michel, additional, Salomo, Morten, additional, Yu, Xin, additional, Nguyen, Tuong Vi, additional, Bensmaine, Amine, additional, Peluso, Teresa, additional, Zaki, Mohamed, additional, and Richardson, Paul, additional

Published
2018
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45. Optimising the value of immunomodulatory drugs during induction and maintenance in transplant ineligible patients with newly diagnosed multiple myeloma: results from Myeloma XI, a multicentre, open‐label, randomised, Phase III trial.

Author

Jackson, Graham H., Pawlyn, Charlotte, Cairns, David A., Striha, Alina, Collett, Corinne, Waterhouse, Anna, Jones, John R., Wilson, Jamie, Taylor, Craig, Kishore, Bhuvan, Garg, Mamta, Williams, Cathy D., Karunanithi, Kamaraj, Lindsay, Jindriska, Jenner, Matthew W., Cook, Gordon, Russell, Nigel H., Drayson, Mark T., Kaiser, Martin F., and Owen, Roger G.

Subjects
MULTIPLE myeloma, OLDER patients, AGE groups, CYCLOPHOSPHAMIDE, TRANSPLANTATION of organs, tissues, etc.
Abstract

Summary: Second‐generation immunomodulatory agents, such as lenalidomide, have a more favourable side‐effect profile than the first‐generation thalidomide, but their optimum combination and duration for patients with newly diagnosed transplant‐ineligible myeloma (ND‐TNE‐MM) has not been defined. The most appropriate delivery and dosing regimens of these therapies for patients at advanced age and frailty status is also unclear. The Myeloma XI study compared cyclophosphamide, thalidomide and dexamethasone (CTDa) to cyclophosphamide, lenalidomide and dexamethasone (CRDa) as induction therapy, followed by a maintenance randomisation between ongoing therapy with lenalidomide or observation for patients with ND‐TNE‐MM. CRDa deepened response but did not improve progression‐free (PFS) or overall survival (OS) compared to CTDa. However, analysis by age group highlighted significant differences in tolerability in older, frailer patients that may have limited treatment delivery and impacted outcome. Deeper responses and PFS and OS benefits with CRDa over CTDs were seen in patients aged ≤70 years, with an increase in toxicity and discontinuation observed in older patients. Our results highlight the importance of considering age and frailty in the approach to therapy for patients with ND‐TNE‐MM, highlighting the need for prospective validation of frailty adapted therapy approaches, which may improve outcomes by tailoring treatment to the individual. [ABSTRACT FROM AUTHOR]

Published
2021
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46. Minimal Residual Disease in the Maintenance Setting in Myeloma: Prognostic Significance and Impact of Lenalidomide

Author

de Tute, Ruth M, primary, Cairns, David, additional, Rawstron, Andy, additional, Pawlyn, Charlotte, additional, Davies, Faith E., additional, Jones, John R, additional, Kaiser, Martin F, additional, Hockaday, Anna, additional, Striha, Alina, additional, Henderson, Rowena, additional, Cook, Gordon, additional, Russell, Nigel H., additional, Drayson, Mark T, additional, Jenner, Matthew W, additional, Gregory, Walter M, additional, Jackson, Graham, additional, Morgan, Gareth J., additional, and Owen, Roger G., additional

Published
2017
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47. Predicting ultrahigh risk multiple myeloma by molecular profiling: an analysis of newly diagnosed transplant eligible myeloma XI trial patients

Author

Shah, Vallari, Sherborne, Amy L., Johnson, David C., Ellis, Sidra, Price, Amy, Chowdhury, Farzana, Kendall, Jack, Jenner, Matthew W., Drayson, Mark T., Owen, Roger G., Gregory, Walter M., Morgan, Gareth J., Davies, Faith E., Cook, Gordon, Cairns, David A., Houlston, Richard S., Jackson, Graham, and Kaiser, Martin F.

Published
2020
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48. The Impact of Maintenance Lenalidomide on the Mutational Status of the Myeloma Clone at Relapse in the NCRI Myeloma XI Trial for Newly Diagnosed Multiple Myeloma Patients (NDMM)

Author

Jones, John R, primary, Weinhold, Niels, additional, Chavan, Shweta S., additional, Pawlyn, Charlotte, additional, Melchor, Lorenzo, additional, Cairns, David A, additional, Begum, Dil B, additional, Smith, Charlotte, additional, Ellis, Sidra, additional, Price, Amy, additional, Sherborne, Amy L, additional, Walker, Brian A, additional, Wardell, Christopher P, additional, Cook, Gordon, additional, Jenner, Matthew W, additional, Russell, Nigel H, additional, Drayson, Mark T, additional, Owen, Roger G, additional, Davies, Faith E, additional, Kaiser, Martin F, additional, Jackson, Graham H, additional, Gregory, Walter M, additional, Greaves, Mel, additional, and Morgan, Gareth J, additional

Published
2016
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49. Real-World Use of Pomalidomide and Dexamethasone in Double Refractory Multiple Myeloma: A Multicentre UK Experience

Author

Maciocia, Nicola, primary, Melville, Andrew, additional, Maciocia, Paul Michael, additional, Cheesman, Simon, additional, Sharpley, Faye, additional, Ramasamy, Karthik, additional, Streetly, Matthew, additional, Jenner, Matthew W, additional, Benjamin, Reuben, additional, Schey, Stephen A, additional, Popat, Rakesh, additional, D'Sa, Shirley, additional, Rismani, Ali, additional, Yong, Kwee L, additional, and Rabin, Neil, additional

Published
2016
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50. A Phase I Dose-Escalation Study of the Class 1 Selective Histone Deacetylase Inhibitor CHR-3996 in Combination with Tosedostat for Patients with Relapsed, Refractory Multiple Myeloma: Results of the Muk Three Trial

Author

Popat, Rakesh, primary, Brown, Sarah R, additional, Tillotson, Avie-Lee, additional, Collinson, Fiona, additional, Flanagan, Louise M, additional, Williams, Cathy D, additional, Yong, Kwee L, additional, Cook, Gordon, additional, Jenner, Matthew W, additional, Kaiser, Martin, additional, Cavet, Jim, additional, El-Sharkawi, Dima, additional, Ng, Chin-Hin, additional, Low, Eric, additional, Morgan, Gareth J, additional, and Davies, Faith E, additional

Published
2016
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