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1. Ixazomib as consolidation and maintenance versus observation in patients with relapsed multiple myeloma eligible for salvage autologous stem-cell transplantation (Myeloma XII [ACCoRD]): interim analysis of a multicentre, open-label, randomised, phase 3 trial

Author

Cook, Gordon, Ashcroft, A John, Senior, Ethan, Olivier, Catherine, Hockaday, Anna, Richards, Jeanine, Cavenagh, Jamie D, Snowden, John A, Drayson, Mark T, de Tute, Ruth, Roberts, Lesley, Owen, Roger G, Yong, Kwee, Garg, Mamta, Boyd, Kevin, Sati, Hamdi, Gillson, Sharon, Cook, Mark, Cairns, David A, and Parrish, Christopher

Published
2024
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5. RNA-seq of newly diagnosed patients in the PADIMAC study leads to a bortezomib/lenalidomide decision signature

Author

Chapman, Michael A., Sive, Jonathan, Ambrose, John, Roddie, Claire, Counsell, Nicholas, Lach, Anna, Abbasian, Mahnaz, Popat, Rakesh, Cavenagh, Jamie D., Oakervee, Heather, Streetly, Matthew J., Schey, Stephen, Koh, Mickey, Willis, Fenella, Virchis, Andres E., Crowe, Josephine, Quinn, Michael F., Cook, Gordon, Crawley, Charles R., Pratt, Guy, Cook, Mark, Braganza, Nivette, Adedayo, Toyin, Smith, Paul, Clifton-Hadley, Laura, Owen, Roger G., Sonneveld, Pieter, Keats, Jonathan J., Herrero, Javier, and Yong, Kwee

Published
2018
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7. Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma

Author

Facon, Thierry, Dimopoulos, Meletios A., Dispenzieri, Angela, Catalano, John V., Belch, Andrew, Cavo, Michele, Pinto, Antonello, Weisel, Katja, Ludwig, Heinz, Bahlis, Nizar J., Banos, Anne, Tiab, Mourad, Delforge, Michel, Cavenagh, Jamie D., Geraldes, Catarina, Lee, Je-Jung, Chen, Christine, Oriol, Albert, De La Rubia, Javier, White, Darrell, Binder, Daniel, Lu, Jin, Anderson, Kenneth C., Moreau, Philippe, Attal, Michel, Perrot, Aurore, Arnulf, Bertrand, Qiu, Lugui, Roussel, Murielle, Boyle, Eileen, Manier, Salomon, Mohty, Mohamad, Avet-Loiseau, Herve, Leleu, Xavier, Ervin-Haynes, Annette, Chen, Guang, Houck, Vanessa, Benboubker, Lotfi, and Hulin, Cyrille

Published
2018
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8. The effect of salvage autologous stem-cell transplantation on overall survival in patients with relapsed multiple myeloma (final results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open-label, phase 3 trial

Author

Cook, Gordon, Ashcroft, A John, Cairns, David A, Williams, Cathy D, Brown, Julia M, Cavenagh, Jamie D, Snowden, John A, Parrish, Christopher, Yong, Kwee, Cavet, Jim, Hunter, Hannah, Bird, Jenny M, Pratt, Guy, Chown, Sally, Heartin, Ernest, O'Connor, Sheila, Drayson, Mark T, Hockaday, Anna, and Morris, Treen C M

Published
2016
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9. The complex genetic landscape of familial MDS and AML reveals pathogenic germline variants

Author

Rio-Machin, Ana, Vulliamy, Tom, Hug, Nele, Walne, Amanda, Tawana, Kiran, Cardoso, Shirleny, Ellison, Alicia, Pontikos, Nikolas, Wang, Jun, Tummala, Hemanth, Al Seraihi, Ahad Fahad H., Alnajar, Jenna, Bewicke-Copley, Findlay, Armes, Hannah, Barnett, Michael, Bloor, Adrian, Bödör, Csaba, Bowen, David, Fenaux, Pierre, Green, Andrew, Hallahan, Andrew, Hjorth-Hansen, Henrik, Hossain, Upal, Killick, Sally, Lawson, Sarah, Layton, Mark, Male, Alison M., Marsh, Judith, Mehta, Priyanka, Mous, Rogier, Nomdedéu, Josep F., Owen, Carolyn, Pavlu, Jiri, Payne, Elspeth M., Protheroe, Rachel E., Preudhomme, Claude, Pujol-Moix, Nuria, Renneville, Aline, Russell, Nigel, Saggar, Anand, Sciuccati, Gabriela, Taussig, David, Toze, Cynthia L., Uyttebroeck, Anne, Vandenberghe, Peter, Schlegelberger, Brigitte, Ripperger, Tim, Steinemann, Doris, Wu, John, Mason, Joanne, Page, Paula, Akiki, Susanna, Reay, Kim, Cavenagh, Jamie D., Plagnol, Vincent, Caceres, Javier F., Fitzgibbon, Jude, and Dokal, Inderjeet

Published
2020
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10. Supplementary Data from Outcome of Azacitidine Therapy in Acute Myeloid Leukemia Is not Improved by Concurrent Vorinostat Therapy but Is Predicted by a Diagnostic Molecular Signature

Author

Craddock, Charles F., primary, Houlton, Aimee E., primary, Quek, Lynn Swun, primary, Ferguson, Paul, primary, Gbandi, Emma, primary, Roberts, Corran, primary, Metzner, Marlen, primary, Garcia-Martin, Natalia, primary, Kennedy, Alison, primary, Hamblin, Angela, primary, Raghavan, Manoj, primary, Nagra, Sandeep, primary, Dudley, Louise, primary, Wheatley, Keith, primary, McMullin, Mary Frances, primary, Pillai, Srinivas P., primary, Kelly, Richard J., primary, Siddique, Shamyla, primary, Dennis, Michael, primary, Cavenagh, Jamie D., primary, and Vyas, Paresh, primary

Published
2023
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11. Supplemental Table 3 from Outcome of Azacitidine Therapy in Acute Myeloid Leukemia Is not Improved by Concurrent Vorinostat Therapy but Is Predicted by a Diagnostic Molecular Signature

Author

Craddock, Charles F., primary, Houlton, Aimee E., primary, Quek, Lynn Swun, primary, Ferguson, Paul, primary, Gbandi, Emma, primary, Roberts, Corran, primary, Metzner, Marlen, primary, Garcia-Martin, Natalia, primary, Kennedy, Alison, primary, Hamblin, Angela, primary, Raghavan, Manoj, primary, Nagra, Sandeep, primary, Dudley, Louise, primary, Wheatley, Keith, primary, McMullin, Mary Frances, primary, Pillai, Srinivas P., primary, Kelly, Richard J., primary, Siddique, Shamyla, primary, Dennis, Michael, primary, Cavenagh, Jamie D., primary, and Vyas, Paresh, primary

Published
2023
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12. Supplemental Table 1 from Outcome of Azacitidine Therapy in Acute Myeloid Leukemia Is not Improved by Concurrent Vorinostat Therapy but Is Predicted by a Diagnostic Molecular Signature

Author

Craddock, Charles F., primary, Houlton, Aimee E., primary, Quek, Lynn Swun, primary, Ferguson, Paul, primary, Gbandi, Emma, primary, Roberts, Corran, primary, Metzner, Marlen, primary, Garcia-Martin, Natalia, primary, Kennedy, Alison, primary, Hamblin, Angela, primary, Raghavan, Manoj, primary, Nagra, Sandeep, primary, Dudley, Louise, primary, Wheatley, Keith, primary, McMullin, Mary Frances, primary, Pillai, Srinivas P., primary, Kelly, Richard J., primary, Siddique, Shamyla, primary, Dennis, Michael, primary, Cavenagh, Jamie D., primary, and Vyas, Paresh, primary

Published
2023
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13. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial

Author

San-Miguel, Jesús F, Hungria, Vânia T M, Yoon, Sung-Soo, Beksac, Meral, Dimopoulos, Meletios Athanasios, Elghandour, Ashraf, Jedrzejczak, Wieslaw Wiktor, Günther, Andreas, Nakorn, Thanyaphong Na, Siritanaratkul, Noppadol, Corradini, Paolo, Chuncharunee, Suporn, Lee, Je-Jung, Schlossman, Robert L, Shelekhova, Tatiana, Yong, Kwee, Tan, Daryl, Numbenjapon, Tontanai, Cavenagh, Jamie D, Hou, Jian, LeBlanc, Richard, Nahi, Hareth, Qiu, Lugui, Salwender, Hans, Pulini, Stefano, Moreau, Philippe, Warzocha, Krzysztof, White, Darrell, Bladé, Joan, Chen, WenMing, de la Rubia, Javier, Gimsing, Peter, Lonial, Sagar, Kaufman, Jonathan L, Ocio, Enrique M, Veskovski, Ljupco, Sohn, Sang Kyun, Wang, Ming-Chung, Lee, Jae Hoon, Einsele, Hermann, Sopala, Monika, Corrado, Claudia, Bengoudifa, Bourras-Rezki, Binlich, Florence, and Richardson, Paul G

Published
2014
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16. Myeloblative therapy with autologous haematopoietic stem cell support as consolidation of first remission in acute myeloid leukaemia – very long follow-up

Author

Rohatiner, Ama Z. S., Smith, Matthew L., Spinelli, Orietta, Rambaldi, Alessandro, Bassan, Renato, di Bona, Eros, Rodeghiero, Francesco, Raimondi, Roberto, Björkholm, Magnus, Johnson, Steve, Newland, Adrian C., Cavenagh, Jamie D., Macdougall, Finlay, Waters, Rachel, Fitzgibbon, Jude, Barbui, Tiziano, and Lister, Andrew

Published
2014
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17. The impact of cytogenetics on duration of response and overall survival in patients with relapsed multiple myeloma (long‐term follow‐up results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open‐label, phase 3 trial

Author

Cook, Gordon, Royle, Kara‐Louise, O'Connor, Sheila, Cairns, David A., Ashcroft, A. John, Williams, Cathy D., Hockaday, Anna, Cavenagh, Jamie D., Snowden, John A., Ademokun, Debo, Tholouli, Eleni, Andrews, Vivienne E., Jenner, Matthew, Parrish, Christopher, Yong, Kwee, Cavet, Jim, Hunter, Hannah, Bird, Jenny M., Pratt, Guy, Drayson, Mark T., Brown, Julia M., and Morris, Treen C. M.

Subjects
Male, relapsed multiple myeloma, overall survival, Kaplan-Meier Estimate, Transplantation, Autologous, cytogenetics, Disease-Free Survival, Translocation, Genetic, Humans, Multicenter Studies as Topic, duration of response, Antineoplastic Agents, Alkylating, Cyclophosphamide, In Situ Hybridization, Fluorescence, Aged, Proportional Hazards Models, Randomized Controlled Trials as Topic, Sequence Deletion, Chromosomes, Human, Pair 14, Salvage Therapy, Haematological Malignancy, Hematopoietic Stem Cell Transplantation, Middle Aged, Combined Modality Therapy, Clinical Trials, Phase III as Topic, salvage ASCT, Female, Chromosomes, Human, Pair 4, Multiple Myeloma, Chromosomes, Human, Pair 16, Research Paper, Chromosomes, Human, Pair 17, Follow-Up Studies
Abstract

Summary The Myeloma X trial (ISCRTN60123120) registered patients with relapsed multiple myeloma. Participants were randomised between salvage autologous stem cell transplantation (ASCT) or weekly cyclophosphamide following re‐induction therapy. Cytogenetic analysis performed at trial registration defined t(4;14), t(14;16) and del(17p) as high‐risk. The effect of cytogenetics on time to progression (TTP) and overall survival was investigated. At 76 months median follow‐up, ASCT improved TTP compared to cyclophosphamide (19 months (95% confidence interval [95% CI] 16–26) vs. 11 months (9–12), hazard ratio [HR]: 0·40, 95% CI: 0·29–0·56, P

Published
2019

18. Mutation of CEBPA in familial acute myeloid leukemia

Author

Smith, Matthew L., Cavenagh, Jamie D., Lister, T. Andrew, and Fitzgibbon, Jude

Subjects
England
Abstract

Case of a family in which multiple members are affected by acute myeloid leukemia (AML) associated with an identical, 212delC mutation in CEBPA is presented. Three large studies of uniformly treated patients indicate that mutation of CEBPA such as 212delC is an independent favorable prognostic factor and appear to carry an even better prognosis than bZIP mutations.

Published
2004

22. Clinical outcome of coronavirus disease 2019 in haemato‐oncology patients

Author

Aries, James A., primary, Davies, Jeffrey K., additional, Auer, Rebecca L., additional, Hallam, Simon L., additional, Montoto, Silvia, additional, Smith, Matthew, additional, Sevillano, Belen, additional, Foggo, Vanessa, additional, Wrench, Bela, additional, Zegocki, Krzysztof, additional, Agrawal, Samir, additional, Le Dieu, Rifca, additional, Truelove, Edward, additional, Erblich, Thomas, additional, Araf, Shamzah, additional, Okosun, Jessica, additional, Oakervee, Heather, additional, Cavenagh, Jamie D., additional, Gribben, John G., additional, and Riches, John C., additional

Published
2020
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24. Reversibility of symptomatic peripheral neuropathy with bortezomib in the phase III APEX trial in relapsed multiple myeloma: impact of a dose-modification guideline

Author

Richardson, Paul G., Sonneveld, Pieter, Schuster, Michael W., Stadtmauer, Edward A., Facon, Thierry, Harousseau, Jean-Luc, Ben-Yehuda, Dina, Lonial, Sagar, Goldschmidt, Hartmut, Reece, Donna, Bladé, Joan, Boccadoro, Mario, Cavenagh, Jamie D., Boral, Anthony L., Esseltine, Dixie-Lee, Wen, Patrick Y., Amato, Anthony A., Anderson, Kenneth C., and San Miguel, Jesus

Published
2009
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26. NK cells CD56brightand CD56dimsubset cytokine loss and exhaustion is associated with impaired survival in myeloma

Author

Seymour, Frances, Cavenagh, Jamie D., Mathews, Janet, and Gribben, John G.

Abstract

Natural killer (NK) cells are the key cells of the innate immune system that share many characteristics with T lymphocytes; their activation, however, is based on the integration of a range of activatory and inhibitory signals via receptors recognizing recurrent pathogen-associated molecular patterns. Two important populations of NK cells with differing functions are recognized: CD56brightand CD56dim. NK cells have the potential to recognize and kill malignant plasma cells, which offers therapeutic opportunities. We used mass cytometry to examine the phenotype and function of NK cell subsets from patients with newly diagnosed multiple myeloma (NDMM). We show that NK cells in NDMM are shifted toward a CD56brightbut dysfunctional cytotoxic phenotype, which exhibits selective loss of cytokine production. The CD56dimsubset has features of exhaustion with impaired proliferation, upregulation of programmed cell death protein 1, and loss of T-cell immunoglobulin and mucin domain 3 expression. Poor expression of NK cell activation markers is seen and is associated with inferior long-term survival. These results suggest that NK cell exhaustion is already present by the time of myeloma diagnosis and likely contributes to the loss of immunologic control of malignant plasma cells. Restoring NK cell function via immune-directed therapies offers a route to restoring immunologic control in multiple myeloma.

Published
2022
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36. Using depth of response to stratify patients to front line Autologous Stem Cell Transplant: results of the phase II PADIMAC Myeloma Trial.

Author

Popat, Rakesh, Counsell, Nicholas, de Tute, Ruth, De‐Silva, Dunnya, Phillips, Elizabeth H., Cavenagh, Jamie D., Adedayo, Toyin, Braganca, Nivette, Roddie, Claire, Streetly, Matthew, Schey, Steve, Koh, Mickey B. C., Crowe, Josephine, Morris, Treen C., Cook, Gordon, Smith, Paul, Clifton‐Hadley, Laura, Rabin, Neil, Owen, Roger, and Yong, Kwee

Subjects
STEM cell transplantation, COVID-19 pandemic
Abstract

Although small numbers, 1/8 MRD-negative standard risk and 1/3 MRD-negative adverse risk patients became MRD-positive at D100; 4/24 MRD-positive standard risk patients converted to MRD-negative, whereas the only adverse risk patient remained positive at D100 (Table SIX). Autologous stem cell transplantation (ASCT) remains the standard of care for younger and fitter multiple myeloma (MM) patients; however, highly effective induction combination regimens have questioned whether ASCT can be deferred. [Extracted from the article]

Published
2021
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37. Final analysis of overall survival from the first trial

Author

Facon, Thierry Dimopoulos, Meletios A. Dispenzieri, Angela and Catalano, John V. Belch, Andrew Cavo, Michele Pinto, Antonello Weisel, Katja Ludwig, Heinz Bahlis, Nizar J. and Banos, Anne Tiab, Mourad Delforge, Michel Cavenagh, Jamie D. and Geraldes, Catarina Lee, Je-Jung Chen, Christine Oriol, Albert De La Rubia, Javier White, Darrell Binder, Daniel and Lu, Jin Anderson, Kenneth C. Moreau, Philippe Attal, Michel and Fermand, Jean-Paul Avet-Loiseau, Herve Ervin-Haynes, Annette and Chen, Guang Houck, Vanessa Hulin, Cyrille Benboubker, Lofti

Subjects
Health Sciences, Επιστήμες Υγείας
Published
2016

38. Outcome of Azacitidine Therapy in Acute Myeloid Leukemia Is not Improved by Concurrent Vorinostat Therapy but Is Predicted by a Diagnostic Molecular Signature

Author

Craddock, Charles F., primary, Houlton, Aimee E., additional, Quek, Lynn Swun, additional, Ferguson, Paul, additional, Gbandi, Emma, additional, Roberts, Corran, additional, Metzner, Marlen, additional, Garcia-Martin, Natalia, additional, Kennedy, Alison, additional, Hamblin, Angela, additional, Raghavan, Manoj, additional, Nagra, Sandeep, additional, Dudley, Louise, additional, Wheatley, Keith, additional, McMullin, Mary Frances, additional, Pillai, Srinivas P., additional, Kelly, Richard J., additional, Siddique, Shamyla, additional, Dennis, Michael, additional, Cavenagh, Jamie D., additional, and Vyas, Paresh, additional

Published
2017
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39. Durable graft-versus-leukaemia effects without donor lymphocyte infusions - results of a phase II study of sequential T-replete allogeneic transplantation for high-risk acute myeloid leukaemia and myelodysplasia

Author

Davies, Jeff K., primary, Hassan, Sandra, additional, Sarker, Shah-Jalal, additional, Besley, Caroline, additional, Oakervee, Heather, additional, Smith, Matthew, additional, Taussig, David, additional, Gribben, John G., additional, and Cavenagh, Jamie D., additional

Published
2017
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40. Patient-Reported Outcome Results From the Open-Label, Randomized Phase III Myeloma X Trial Evaluating Salvage Autologous Stem-Cell Transplantation in Relapsed Multiple Myeloma.

Author

Ahmedzai, Sam H., Snowden, John A., Ashcroft, Andrew John, Cairns, David Allan, Williams, Cathy, Hockaday, Anna, Cavenagh, Jamie D., Ademokun, Debo, Tholouli, Eleni, Allotey, David, Dhanapal, Vijay, Jenner, Matthew, Yong, Kwee, Cavet, Jim, Hunter, Hannah, Bird, Jennifer M., Pratt, Guy, Parrish, Christopher, Brown, Julia M., and Morris, Treen C.M.

Published
2019
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41. The impact of cytogenetics on duration of response and overall survival in patients with relapsed multiple myeloma (long‐term follow‐up results from BSBMT/UKMF Myeloma X Relapse [Intensive]): a randomised, open‐label, phase 3 trial.

Author

Parrish, Christopher, Cook, Gordon, Andrews, Vivienne E., Jenner, Matthew, Yong, Kwee, Cavet, Jim, Hunter, Hannah, Bird, Jenny M., Pratt, Guy, Drayson, Mark T., Morris, Treen C. M., Royle, Kara‐Louise, Cairns, David A., Hockaday, Anna, Brown, Julia M., O'Connor, Sheila, Ashcroft, A. John, Williams, Cathy D., Cavenagh, Jamie D., and Snowden, John A.

Subjects
MULTIPLE myeloma, STEM cell transplantation, LIKELIHOOD ratio tests
Abstract

Summary: The Myeloma X trial (ISCRTN60123120) registered patients with relapsed multiple myeloma. Participants were randomised between salvage autologous stem cell transplantation (ASCT) or weekly cyclophosphamide following re‐induction therapy. Cytogenetic analysis performed at trial registration defined t(4;14), t(14;16) and del(17p) as high‐risk. The effect of cytogenetics on time to progression (TTP) and overall survival was investigated. At 76 months median follow‐up, ASCT improved TTP compared to cyclophosphamide (19 months (95% confidence interval [95% CI] 16–26) vs. 11 months (9–12), hazard ratio [HR]: 0·40, 95% CI: 0·29–0·56, P < 0·001), on which the presence of any single high‐risk lesion had a detrimental impact [likelihood ratio test (LRT): P = 0·011]. ASCT also improved OS [67 months (95% CI 59‐not reached) vs. 55 months (44–67), HR: 0·64, 95% CI: 0·42–0·99, P = 0·0435], with evidence of a detrimental impact with MYC rearrangement (LRT: P = 0·021). Twenty‐one (24·7%) cyclophosphamide patients received an ASCT post‐trial, median OS was not reached (95% CI: 39‐not reached) for these participants compared to 31 months (22–39), in those who did not receive a post‐trial ASCT. The analysis further supports the benefit of salvage ASCT, which may still be beneficial after second relapse in surviving patients. There is evidence that this benefit reduces in cytogenetic high‐risk patients, highlighting the need for targeted study in this patient group. [ABSTRACT FROM AUTHOR]

Published
2019
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42. Variable Penetrance Is Linked with Monoallelic Gene Expression in Inherited GATA2-Mutated MDS/AML

Author

Al Seraihi, Ahad, primary, Rio-Machin, Ana, additional, Tawana, Kiran, additional, Bödör, Csaba, additional, Araf, Shamzah, additional, Heward, James A, additional, Smith, Matthew, additional, Iqbal, Sameena, additional, Best, Steven, additional, Lea, Nicholas, additional, McLornan, Donal, additional, Ellison, Alicia, additional, Tummala, Hemanth, additional, Romualdo Cardoso, Shirleny, additional, Cavenagh, Jamie D., additional, Vulliamy, Tom, additional, Dokal, Inderjeet, additional, and Fitzgibbon, Jude, additional

Published
2016
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43. Final Analysis of Overall Survival from the First Trial

Author

Facon, Thierry, primary, Dimopoulos, Meletios A, additional, Dispenzieri, Angela, additional, Catalano, John V., additional, Belch, Andrew, additional, Cavo, Michele, additional, Pinto, Antonello, additional, Weisel, Katja, additional, Ludwig, Heinz, additional, Bahlis, Nizar J., additional, Banos, Anne, additional, Tiab, Mourad, additional, Delforge, Michel, additional, Cavenagh, Jamie D., additional, Geraldes, Catarina, additional, Lee, Je-Jung, additional, Chen, Christine, additional, Oriol, Albert, additional, De La Rubia, Javier, additional, White, Darrell, additional, Binder, Daniel, additional, Lu, Jin, additional, Anderson, Kenneth C., additional, Moreau, Philippe, additional, Attal, Michel, additional, Fermand, Jean-Paul, additional, Avet-Loiseau, Herve, additional, Ervin-Haynes, Annette, additional, Chen, Guang, additional, Houck, Vanessa, additional, Hulin, Cyrille, additional, and Benboubker, Lofti, additional

Published
2016
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44. Immune Biomarkers Identify Sustained Quantitative and Functional Immune Reconstitution in the Setting of Adjunctive Lenalidomide Following T-Depleted RIC-Allo SCT for Multiple Myeloma

Author

Cook, Gordon, primary, Carter, Clive R, additional, Brock, Kristian, additional, McQuaker, Grant, additional, Snowden, John A, additional, Crawley, Charles, additional, Hunter, Hannah, additional, Cavenagh, Jamie D., additional, Lobb, Mark, additional, Cullen, Katherine, additional, Hodgkinson, Andrea, additional, Sirovica, Mirjana, additional, and Cook, Mark, additional

Published
2016
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45. Vorinostat Does Not Improve Outcome in Patients with Acute Myeloid Leukemia and High Risk Myelodysplasia Treated with Azacitidine: Results of the UK Trials Acceleration Programme Ravva Trial

Author

Craddock, Charles, primary, Houlton, Aimee E, additional, Ferguson, Paul, additional, Raghavan, Manoj, additional, Fox, Sonia, additional, Dudley, Louise, additional, Quek, Lynn Swun, additional, Cavenagh, Jamie D., additional, Dennis, Michael, additional, McMullin, Mary Frances, additional, Pillai, Srinivas P, additional, Kelly, Richard, additional, Siddique, Shamyla, additional, Wheatley, Keith, additional, and Vyas, Paresh, additional

Published
2016
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46. Panobinostat plus bortezomib and dexamethasone versus placebo plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma: a multicentre, randomised, double-blind phase 3 trial

Author

San-Miguel, Jesus F. Hungria, Vania T. M. Yoon, Sung-Soo and Beksac, Meral Dimopoulos, Meletios Athanasios Elghandour, Ashraf and Jedrzejczak, Wieslaw Wiktor Guenther, Andreas Nakorn, Thanyaphong Na Siritanaratkul, Noppadol Corradini, Paolo and Chuncharunee, Suporn Lee, Je-Jung Schlossman, Robert L. and Shelekhova, Tatiana Yong, Kwee Tan, Daryl Numbenjapon, Tontanai Cavenagh, Jamie D. Hou, Jian LeBlanc, Richard and Nahi, Hareth Qiu, Lugui Salwender, Hans Pulini, Stefano and Moreau, Philippe Warzocha, Krzysztof White, Darrell Blade, Joan Chen, WenMing de la Rubia, Javier Gimsing, Peter and Lonial, Sagar Kaufman, Jonathan L. Ocio, Enrique M. and Veskovski, Ljupco Sohn, Sang Kyun Wang, Ming-Chung Lee, Jae Hoon Einsele, Hermann Sopala, Monika Corrado, Claudia and Bengoudifa, Bourras-Rezki Binlich, Florence Richardson, Paul G.

Subjects
Health Sciences, Επιστήμες Υγείας
Abstract

Background Panobinostat is a potent oral pan-deacetylase inhibitor that in preclinical studies has synergistic antimyeloma activity when combined with bortezomib and dexamethasone. We aimed to compare panobinostat, bortezomib, and dexamethasone with placebo, bortezomib, and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma. Methods PANORAMA1 is a multicentre, randomised, placebo-controlled, double-blind phase 3 trial of patients with relapsed or relapsed and refractory multiple myeloma who have received between one and three previous treatment regimens. Patients were randomly assigned (1:1) via an interactive web-based and voice response system, stratified by number of previous treatment lines and by previous use of bortezomib, to receive 21 day cycles of placebo or panobinostat (20 mg; on days 1, 3, 5, 8, 10, 12, orally), both in combination with bortezomib (1.3 mg/m(2) on days 1, 4, 8, 11, intravenously) and dexamethasone (20 mg on days 1, 2, 4, 5, 8, 9, 11, 12, orally). Patients, physicians, and the investigators who did the data analysis were masked to treatment allocation; crossover was not permitted. The primary endpoint was progression-free survival (in accordance with modified European Group for Blood and Marrow Transplantation criteria and based on investigators’ assessment) and was analysed by intention to treat. The study is ongoing, but no longer recruiting, and is registered at ClinicalTrials.gov, number NCT01023308. Findings 768 patients were enrolled between Jan 21, 2010, and Feb 29, 2012, with 387 randomly assigned to panobinostat, bortezomib, and dexamethasone and 381 to placebo, bortezomib, and dexamethasone. Median follow-up was 6.47 months (IQR 1.81-13.47) in the panobinostat group and 5.59 months (2.14-11.30) in the placebo group. Median progression-free survival was significantly longer in the panobinostat group than in the placebo group (11.99 months [95% CI 10.33-12.94] vs 8.08 months [7.56-9.23]; hazard ratio [HR] 0.63, 95% CI 0.52-0.76; p

Published
2014

47. Panobinostat Plus Azacitidine in Adult Patients with MDS, CMML, or AML: Results of a Phase 2b Study

Author

Garcia-Manero, Guillermo, primary, Sekeres, Mikkael A., additional, Egyed, Miklos, additional, Alimena, Giuliana, additional, Graux, Carlos, additional, Cavenagh, Jamie D., additional, Salman, Huda, additional, Illes, Arpad, additional, Fenaux, Pierre, additional, DeAngelo, Daniel J., additional, Stauder, Reinhard, additional, Yee, Karen, additional, Zhu, Nancy Y, additional, Lee, Je-Hwan, additional, Valcarcel, David, additional, MacWhannell, Alan, additional, Borbenyi, Zita, additional, Wegener, Antje, additional, Gazi, Lucien, additional, Acharyya, Suddhasatta, additional, Binlich, Florence, additional, and Ottmann, Oliver G., additional

Published
2015
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