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1. 3‐Year outcomes of adults with relapsed or refractory B‐cell acute lymphoblastic leukemia treated with brexu‐cel in ZUMA‐3 by age, prior therapies, and subsequent transplant

Author

Shah, B. D., primary, Cassaday, R. D., additional, Park, J. H., additional, Houot, R., additional, Oluwole, O. O., additional, Logan, A. C., additional, Boissel, N., additional, Leguay, T., additional, Bishop, M. R., additional, Topp, M. S., additional, O’Dwyer, K. M., additional, Baer, M. R., additional, Schiller, G. J., additional, Abedi, M., additional, Minnema, M. C., additional, Stiff, P., additional, Zhou, L., additional, Hadjivassileva, T., additional, Khalid, R. Damico, additional, and Ghobadi, A. Armin, additional

Published
2023
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5. OS03.6.A Rituximab in primary CNS lymphoma - long term follow-up of the phase III HOVON 105/ALLG NHL 24 Study

Author

Bromberg, J E C, primary, Issa, S, additional, van der Holt, B, additional, Minnema, M C, additional, Seute, T, additional, Durian, M F, additional, Cull, G, additional, van der Poel, M W M, additional, Stevens, W B C, additional, Zijlstra, J M, additional, Nijland, M, additional, Mason, K D, additional, Beeker, A, additional, Brandsma, D, additional, van den Bent, M J, additional, Gonzalez, M, additional, de Jong, D, additional, and Doorduijn, J K, additional

Published
2022
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7. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma

Author

Bishop, M. R., Dickinson, M., Purtill, D., Barba, P., Santoro, A., Hamad, N., Kato, K., Sureda, A., Greil, R., Thieblemont, C., Morschhauser, F., Janz, M., Flinn, I, Rabitsch, W., Kwong, Y-L, Kersten, M. J., Minnema, M. C., Holte, H., Chan, E. H. L., Martinez-Lopez, J., Mueller, A. M. S., Maziarz, R. T., McGuirk, J. P., Bachy, E., Le Gouill, S., Dreyling, M., Harigae, H., Bond, D., Andreadis, C., McSweeney, P., Kharfan-Dabaja, M., Newsome, S., Degtyarev, E., Awasthi, R., del Corral, C., Andreola, G., Masood, A., Schuster, S. J., Jaeger, U., Borchmann, P., Westin, J. R., Bishop, M. R., Dickinson, M., Purtill, D., Barba, P., Santoro, A., Hamad, N., Kato, K., Sureda, A., Greil, R., Thieblemont, C., Morschhauser, F., Janz, M., Flinn, I, Rabitsch, W., Kwong, Y-L, Kersten, M. J., Minnema, M. C., Holte, H., Chan, E. H. L., Martinez-Lopez, J., Mueller, A. M. S., Maziarz, R. T., McGuirk, J. P., Bachy, E., Le Gouill, S., Dreyling, M., Harigae, H., Bond, D., Andreadis, C., McSweeney, P., Kharfan-Dabaja, M., Newsome, S., Degtyarev, E., Awasthi, R., del Corral, C., Andreola, G., Masood, A., Schuster, S. J., Jaeger, U., Borchmann, P., and Westin, J. R.

Abstract

BACKGROUND Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy. Tisagenlecleucel is an anti-CD19 chimeric antigen receptor T-cell therapy approved for diffuse large B-cell lymphoma after at least two treatment lines. METHODS We conducted an international phase 3 trial involving patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy. Patients were randomly assigned to receive tisagenlecleucel with optional bridging therapy (tisagenlecleucel group) or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (HSCT) (standard-care group). The primary end point was event-free survival, defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death. Crossover to receive tisagenlecleucel was allowed if a defined event occurred at or after the week 12 assessment. Other end points included response and safety. RESULTS A total of 322 patients underwent randomization. At baseline, the percentage of patients with high-grade lymphomas was higher in the tisagenlecleucel group than in the standard-care group (24.1% vs. 16.9%), as was the percentage with an International Prognostic Index score (range, 0 to 5, with higher scores indicating a worse prognosis) of 2 or higher (65.4% vs. 57.5%). A total of 95.7% of the patients in the tisagenlecleucel group received tisagenlecleucel; 32.5% of the patients in the standard-care group received autologous HSCT. The median time from leukapheresis to tisagenlecleucel infusion was 52 days. A total of 25.9% of the patients in the tisagenlecleucel group had lymphoma progression at week 6, as compared with 13.8% of those in the standard-care group. The median event-free survival in both groups was 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07; 95% confidence interval, 0.82 to 1.40; P=0.61).

Published
2022

8. S182: TALQUETAMAB, A G PROTEIN-COUPLED RECEPTOR FAMILY C GROUP 5 MEMBER D X CD3 BISPECIFIC ANTIBODY, IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: UPDATED EFFICACY AND SAFETY RESULTS FROM MONUMENTAL-1

Author

Minnema, M. C., primary, Krishnan, A., additional, Berdeja, J. G., additional, Oriol, A., additional, van de Donk, N. W., additional, Rodríguez-Otero, P., additional, Morillo, D., additional, Mateos, M.-V., additional, Costa, L. J., additional, Caers, J., additional, Vishwamitra, D., additional, Ma, J., additional, Yang, S., additional, Hilder, B. W., additional, Tolbert, J., additional, Goldberg, J. D., additional, and Chari, A., additional

Published
2022
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9. P1714: HEALTHCARE RESOURCE UTILIZATION IN PATIENTS WITH LIGHT CHAIN AMYLOIDOSIS IN EUROPE

Author

Jaccard, A., primary, Bridoux, F., additional, Roeloffzen, W., additional, Minnema, M. C., additional, Bergantim, R., additional, Hájek, R., additional, João, C., additional, Cibeira, M. T., additional, Palladini, G., additional, Schönland, S., additional, Merlini, G., additional, Milani, P., additional, Dimopoulos, M. A., additional, Ravichandran, S., additional, Hegenbart, U., additional, Agis, H., additional, Gros, B., additional, Asra, A., additional, Dergarabetian, E., additional, Magarotto, V., additional, Leonidakis, A., additional, Cheliotis, G., additional, Sonneveld, P., additional, Wechalekar, A., additional, and Kastritis, E., additional

Published
2022
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10. P939: SYNERGISTIC EFFECTS OF LOW DOSE BELANTAMAB MAFODOTIN IN COMBINATION WITH A GAMMA-SECRETASE INHIBITOR (NIROGACESTAT) IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): DREAMM-5 STUDY

Author

Nooka, A., primary, Lonial, S., additional, Grosicki, S., additional, Hus, M., additional, Song, K., additional, Facon, T., additional, Callander, N. S., additional, Ribrag, V., additional, Uttervall, K., additional, Quach, H., additional, Vorobyev, V., additional, Min, C.-K., additional, Cheng, S., additional, Smith, L. M., additional, Yu, J., additional, Collingwood, T., additional, Holkova, B., additional, Kremer, B. E., additional, Gupta, I. V., additional, Richardson, P. G., additional, and Minnema, M. C., additional

Published
2022
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11. P915: EFFICACY AND SAFETY OF DARATUMUMAB MONOTHERAPY IN NEWLY DIAGNOSED PATIENTS WITH STAGE 3B LIGHT CHAIN AMYLOIDOSIS: A PHASE 2 STUDY BY THE EUROPEAN MYELOMA NETWORK

Author

Kastritis, E., primary, Minnema, M. C., additional, Dimopoulos, M. A., additional, Merlini, G., additional, Theodorakakou, F., additional, Fotiou, D., additional, Huart, A., additional, Belhadj, K., additional, Gkolfinopoulos, S., additional, Manousou, K., additional, Sonneveld, P., additional, and Palladini, G., additional

Published
2022
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12. P914: EFFICACY AND SAFETY OF BELANTAMAB MAFODOTIN MONOTHERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY LIGHT CHAIN AMYLOIDOSIS: A PHASE 2 STUDY BY THE EUROPEAN MYELOMA NETWORK

Author

Kastritis, E., primary, Palladini, G., additional, Dimopoulos, M. A., additional, Jaccard, A., additional, Merlini, G., additional, Theodorakakou, F., additional, Fotiou, D., additional, Minnema, M. C., additional, Wechalekar, A., additional, Gkolfinopoulos, S., additional, Manousou, K., additional, Sonneveld, P., additional, and Schönland, S., additional

Published
2022
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13. P1105: FINAL RESULTS OF THE PHASE I/II HOVON124/ECWM-R2 STUDY INCLUDING 2-YEAR RITUXIMAB MAINTENANCE AFTER INDUCTION WITH IXAZOMIB, RITUXIMAB AND DEXAMETHASONE IN RELAPSED WALDENSTRÖM’S MACROGLOBULINEMIA

Author

Dimopoulos, M.-A., primary, Amaador, K., additional, Minnema, M. C., additional, Nasserinejad, K., additional, Kap, M., additional, Kastritis, E., additional, Gavriatopoulou, M., additional, Kraan, W., additional, Chamuleau, M. E. D., additional, Deeren, D., additional, Tick, L., additional, Doorduijn, J. K., additional, Offner, F., additional, Böhmer, L. H., additional, Liu, R. D., additional, Pals, S. T., additional, Vos, J. M., additional, and Kersten, M. J., additional

Published
2022
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14. P356: SUBGROUP ANALYSES OF KTE-X19, AN ANTI-CD19 CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY, IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) IN ZUMA-3

Author

Shah, B. D., primary, Cassaday, R. D., additional, Park, J. H., additional, Houot, R., additional, Oluwole, O. O., additional, Logan, A. C., additional, Boissel, N., additional, Leguay, T., additional, Bishop, M. R., additional, Topp, M. S., additional, Tzachanis, D., additional, O’Dwyer, K. M., additional, Arellano, M. L., additional, Lin, Y., additional, Baer, M. R., additional, Schiller, G. J., additional, Subklewe, M., additional, Abedi, M., additional, Minnema, M. C., additional, Wierda, W. G., additional, DeAngelo, D. J., additional, Stiff, P., additional, Jeyakumar, D., additional, Dong, J., additional, Adhikary, S., additional, Zhou, L., additional, Schuberth, P. C., additional, Kharabi Masouleh, B., additional, and Ghobadi, A., additional

Published
2022
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15. P10: TALQUETAMAB, A G PROTEIN-COUPLED RECEPTOR FAMILY C GROUP 5 MEMBER D X CD3 BISPECIFIC ANTIBODY, IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM): UPDATED PHASE 1 RESULTS FROM MONUMENTAL-1

Author

van de Donk, N. W. C. J, primary, Minnema, M C, additional, Berdeja, J G, additional, Oriol, A, additional, Krishnan, A, additional, Rodríguez-Otero, P, additional, Askari, E, additional, Mateos, M, additional, Costa, L. J, additional, Verona, R, additional, Ma, J, additional, Girgis, S, additional, Yang, S, additional, Hilder, B. W, additional, Russell, J, additional, Goldberg, J. D, additional, and Chari, A, additional

Published
2022
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16. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis

Author

Kastritis E., Palladini G., Minnema M. C., Wechalekar A. D., Jaccard A., Lee H. C., Sanchorawala V., Gibbs S., Mollee P., Venner C. P., Lu J., Schonland S., Gatt M. E., Suzuki K., Kim K., Cibeira M. T., Beksac M., Libby E., Valent J., Hungria V., Wong S. W., Rosenzweig M., Bumma N., Huart A., Dimopoulos M. A., Bhutani D., Waxman A. J., Goodman S. A., Zonder J. A., Lam S., Song K., Hansen T., Manier S., Roeloffzen W., Jamroziak K., Kwok F., Shimazaki C., Kim J. -S., Crusoe E., Ahmadi T., Tran N., Qin X., Vasey S. Y., Tromp B., Schecter J. M., Weiss B. M., Zhuang S. H., Vermeulen J., Merlini G., Comenzo R. L., Bradley Augustson, Fiona Kwok, Peter Mollee, Simon Gibbs, Chantal Doyen, Greet Bries, Isabelle Vande Broek, Ka Lung Wu, Koen Theunissen, Koen Van Eygen, Michel Delforge, Nathalie Meuleman, Philip Vlummens, Angelo Maiolino, Breno Moreno de Gusmão, Carlos Eduardo Miguel, Edvan Crusoe, Fernanda Moura, Fernanda Seguro, Jandey Bigonha, Juliane Musacchio, Karla Zanella, Laura Garcia, Marcelo Eduardo Zanella Capra, Reijane Alves de Assis, Rosane Bittencourt, Vania Hungria, Walter Braga, Wolney Barreto, Christopher Venner, Donna Reece, Emilie Lemieux-Blanchard, Kevin Song, Michael Sebag, Selay Lam, Victor Zepeda, Haitao Zhang, Jianda Hu, Jin Lu, Juan Li, Songfu Jiang, Ting Niu, Wenming Chen, Xiaonong Chen, Zhen Cai, Zhou Fude, Maja Oelholm Vase, Morten Salomo, Niels Abildgaard, Alain Fuzibet, Anne-Marie Stoppa, Arnaud Jaccard, Bertrand Arnulf, Bruno Moulin, Bruno Royer, David Ghez, Denis Caillot, Dominique Chauveau, Franck Bridoux, Lauriane Clement-Filliatre, Lionel Karlin, Lotfi Benboubker, Mamoun Dib, Margaret Macro, Mohamad Mohty, Olivier Decaux, Olivier Hermine, Olivier Tournilhac, Philippe Moreau, Salomon Manier, Sylvain Choquet, Véronique Dorvaux, Alexander Carpinteiro, Axel Nogai, Britta Besemer, Christoph Roellig, Roland Fenk, Stefan Knop, Stefan Schönland, Timon Hansen, Argiris Symeonidis, Efstathios Kastritis, Gabor Mikala, Tamás Masszi, Zsolt Nagy, Celia Suriu, Hila Magen, Iuliana Vaxman, Lev Shvidel, Meir Preis, Moshe Gatt, Noa Lavi, Osnat Jarchowsky, Tamar Tadmor, Yael Cohen, Angelo Vacca, Giovanni Palladini, Mario Boccadoro, Maurizio Martelli, Maurizio Musso, Michele Cavo, Chihiro Shimazaki, Hiroyuki Takamatsu, Kazutaka Sunami, Kenshi Suzuki, Nagaaki Katoh, Shinsuke Iida, Takayuki Ikezoe, Tomoaki Fujisaki, Yuta Katayama, Chang Ki Min, Ho-Jin Shin, Jin Seok Kim, Jung Yong Hong, Ki Hyun Kim, Sung-Soo Yoon, Aline Ramirez, Alvaro Cabrera, Christian Ramos, David Gomez Almaguer, Deborah Martinez, Guillermo Ruiz, Helen Dayani Caballero, Juan Antonio Flores Jimenez, Annemiek Broijl, Laurens Nieuwenhuizen, Monique Minnema, Paula Ypma, Wilfried Roeloffzen, Dominik Dytfeld, Grzegorz Charlinski, Grzegorz Helbig, Krzysztof Jamroziak, Sebastian Grosicki, Wieslaw Jedrzejczak, Albert Oriol Rocafiguera, Elham Askari, Fernando Escalante Barrigon, Isabel Krsnik Castello, Javier De la Rubia Comos, Jesus Martin Sanchez, Joaquin Martinez Lopez, Jose Angel Hernandez Rivas, Luis Felipe Casado Montero, Maria Jesus Blanchard Rodriguez, Maria Teresa Cibeira Lopez, Maria Victoria Mateos Manteca, Marta Sonia Gonzalez Perez, Mercedes Gironella Mesa, Rafael Rios Tamayo, Ramon Lecumberri Villamediana, Ricarda Garcia Sanchez, Sunil Lakhwani, Yolanda Gonzalez, Hareth Nahi, Kristina Carlsson, Markus Hansson, Ulf-Henrik Mellqvist, Ali Unal, Burhan Ferhanoglu, Hayri Ozsan, Levent Undar, Mehmet Turgut, Mehmet Yilmaz, Meral Beksac, Muhlis Cem Ar, Muzaffer Demir, Sevgi Besisik, Ashutosh Wechalekar, Jamie Cavenagh, Jim Cavet, Mark Cook, Rachel Hall, Adam Waxman, Anuj Mahindra, Cesar Rodriguez Valdes, Christine Ye, Craig Reeder, Daphne Friedman, David Siegel, Divaya Bhutani, Edward Libby, Eva Medvedova, Frank Passero, Giada Bianchi, Giampaolo Talamo, Guido Tricot, Hans Lee, Heather Landau, Jan Moreb, Jason Valent, Jeffrey Matous, Jeffrey A Zonder, Jesus Berdeja, Jonathan Kaufman, Keith Stockerl-Goldstein, Keren Osman, Ketan Doshi, Kevin Barton, Larry Anderson, Manisha Bhutani, Mehmet Kocoglu, Michael Rosenzweig, Michael Schuster, Michaela Liedtke, Morie Gertz, Naresh Bumma, Natalie Callander, Raymond Comenzo, Robert Vescio, Roger Pearse, Sandy W Wong, Stacey A Goodman, Stefano Tarantolo, Taimur Sher, Tibor Kovacsovics, Tomer Mark, Vaishali Sanchorawala, William Bensinger, Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), Université Clermont Auvergne (UCA), Kastritis E., Palladini G., Minnema M.C., Wechalekar A.D., Jaccard A., Lee H.C., Sanchorawala V., Gibbs S., Mollee P., Venner C.P., Lu J., Schonland S., Gatt M.E., Suzuki K., Kim K., Cibeira M.T., Beksac M., Libby E., Valent J., Hungria V., Wong S.W., Rosenzweig M., Bumma N., Huart A., Dimopoulos M.A., Bhutani D., Waxman A.J., Goodman S.A., Zonder J.A., Lam S., Song K., Hansen T., Manier S., Roeloffzen W., Jamroziak K., Kwok F., Shimazaki C., Kim J.-S., Crusoe E., Ahmadi T., Tran N., Qin X., Vasey S.Y., Tromp B., Schecter J.M., Weiss B.M., Zhuang S.H., Vermeulen J., Merlini G., and Comenzo R.L., Bradley Augustson, Fiona Kwok, Peter Mollee, Simon Gibbs, Chantal Doyen, Greet Bries, Isabelle Vande Broek, Ka Lung Wu, Koen Theunissen, Koen Van Eygen, Michel Delforge, Nathalie Meuleman, Philip Vlummens, Angelo Maiolino, Breno Moreno de Gusmão, Carlos Eduardo Miguel, Edvan Crusoe, Fernanda Moura, Fernanda Seguro, Jandey Bigonha, Juliane Musacchio, Karla Zanella, Laura Garcia, Marcelo Eduardo Zanella Capra, Reijane Alves de Assis, Rosane Bittencourt, Vania Hungria, Walter Braga, Wolney Barreto, Christopher Venner, Donna Reece, Emilie Lemieux-Blanchard, Kevin Song, Michael Sebag, Selay Lam, Victor Zepeda, Haitao Zhang, Jianda Hu, Jin Lu, Juan Li, Songfu Jiang, Ting Niu, Wenming Chen, Xiaonong Chen, Zhen Cai, Zhou Fude, Maja Oelholm Vase, Morten Salomo, Niels Abildgaard, Alain Fuzibet, Anne-Marie Stoppa, Arnaud Jaccard, Bertrand Arnulf, Bruno Moulin, Bruno Royer, David Ghez, Denis Caillot, Dominique Chauveau, Franck Bridoux, Lauriane Clement-Filliatre, Lionel Karlin, Lotfi Benboubker, Mamoun Dib, Margaret Macro, Mohamad Mohty, Olivier Decaux, Olivier Hermine, Olivier Tournilhac, Philippe Moreau, Salomon Manier, Sylvain Choquet, Véronique Dorvaux, Alexander Carpinteiro, Axel Nogai, Britta Besemer, Christoph Roellig, Roland Fenk, Stefan Knop, Stefan Schönland, Timon Hansen, Argiris Symeonidis, Efstathios Kastritis, Gabor Mikala, Tamás Masszi, Zsolt Nagy, Celia Suriu, Hila Magen, Iuliana Vaxman, Lev Shvidel, Meir Preis, Moshe Gatt, Noa Lavi, Osnat Jarchowsky, Tamar Tadmor, Yael Cohen, Angelo Vacca, Giovanni Palladini, Mario Boccadoro, Maurizio Martelli, Maurizio Musso, Michele Cavo, Chihiro Shimazaki, Hiroyuki Takamatsu, Kazutaka Sunami, Kenshi Suzuki, Nagaaki Katoh, Shinsuke Iida, Takayuki Ikezoe, Tomoaki Fujisaki, Yuta Katayama, Chang Ki Min, Ho-Jin Shin, Jin Seok Kim, Jung Yong Hong, Ki Hyun Kim, Sung-Soo Yoon, Aline Ramirez, Alvaro Cabrera, Christian Ramos, David Gomez Almaguer, Deborah Martinez, Guillermo Ruiz, Helen Dayani Caballero, Juan Antonio Flores Jimenez, Annemiek Broijl, Laurens Nieuwenhuizen, Monique Minnema, Paula Ypma, Wilfried Roeloffzen, Dominik Dytfeld, Grzegorz Charlinski, Grzegorz Helbig, Krzysztof Jamroziak, Sebastian Grosicki, Wieslaw Jedrzejczak, Albert Oriol Rocafiguera, Elham Askari, Fernando Escalante Barrigon, Isabel Krsnik Castello, Javier De la Rubia Comos, Jesus Martin Sanchez, Joaquin Martinez Lopez, Jose Angel Hernandez Rivas, Luis Felipe Casado Montero, Maria Jesus Blanchard Rodriguez, Maria Teresa Cibeira Lopez, Maria Victoria Mateos Manteca, Marta Sonia Gonzalez Perez, Mercedes Gironella Mesa, Rafael Rios Tamayo, Ramon Lecumberri Villamediana, Ricarda Garcia Sanchez, Sunil Lakhwani, Yolanda Gonzalez, Hareth Nahi, Kristina Carlsson, Markus Hansson, Ulf-Henrik Mellqvist, Ali Unal, Burhan Ferhanoglu, Hayri Ozsan, Levent Undar, Mehmet Turgut, Mehmet Yilmaz, Meral Beksac, Muhlis Cem Ar, Muzaffer Demir, Sevgi Besisik, Ashutosh Wechalekar, Jamie Cavenagh, Jim Cavet, Mark Cook, Rachel Hall, Adam Waxman, Anuj Mahindra, Cesar Rodriguez Valdes, Christine Ye, Craig Reeder, Daphne Friedman, David Siegel, Divaya Bhutani, Edward Libby, Eva Medvedova, Frank Passero, Giada Bianchi, Giampaolo Talamo, Guido Tricot, Hans Lee, Heather Landau, Jan Moreb, Jason Valent, Jeffrey Matous, Jeffrey A Zonder, Jesus Berdeja, Jonathan Kaufman, Keith Stockerl-Goldstein, Keren Osman, Ketan Doshi, Kevin Barton, Larry Anderson, Manisha Bhutani, Mehmet Kocoglu, Michael Rosenzweig, Michael Schuster, Michaela Liedtke, Morie Gertz, Naresh Bumma, Natalie Callander, Raymond Comenzo, Robert Vescio, Roger Pearse, Sandy W Wong, Stacey A Goodman, Stefano Tarantolo, Taimur Sher, Tibor Kovacsovics, Tomer Mark, Vaishali Sanchorawala, William Bensinger

Subjects
Male, Treatment outcome, Immunoglobulin Light-chain Amyloidosis/drug therapy, CD38, Dexamethasone, Cyclophosphamide/administration & dosage, Bortezomib, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Medicine, CRITERIA, Immunoglobulin Light-chain Amyloidosis, ComputingMilieux_MISCELLANEOUS, Aged, 80 and over, biology, Amyloidosis, Antibodies, Monoclonal, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, General Medicine, Middle Aged, 3. Good health, Treatment Outcome, 030220 oncology & carcinogenesis, Female, Antibody, Human, Adult, Dexamethasone/administration & dosage, ANTIBODY DARATUMUMAB, Immunoglobulin light chain, DIAGNOSIS, Antibodies, Monoclonal/administration & dosage, Disease-Free Survival, 03 medical and health sciences, Humans, Cyclophosphamide, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, AL AMYLOIDOSIS, Daratumumab, Amyloid fibril, medicine.disease, Molecular biology, Immunoglobulin Light-chain Amyloidosi, biology.protein, Bortezomib/administration & dosage, business, 030215 immunology
Abstract

Systemic immunoglobulin light-chain (AL) amyloidosis is characterized by deposition of amyloid fibrils of light chains produced by clonal CD38+ plasma cells. Daratumumab, a human CD38-targeting antibody, may improve outcomes for this disease.We randomly assigned patients with newly diagnosed AL amyloidosis to receive six cycles of bortezomib, cyclophosphamide, and dexamethasone either alone (control group) or with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles (daratumumab group). The primary end point was a hematologic complete response.A total of 388 patients underwent randomization. The median follow-up was 11.4 months. The percentage of patients who had a hematologic complete response was significantly higher in the daratumumab group than in the control group (53.3% vs. 18.1%) (relative risk ratio, 2.9; 95% confidence interval [CI], 2.1 to 4.1; P0.001). Survival free from major organ deterioration or hematologic progression favored the daratumumab group (hazard ratio for major organ deterioration, hematologic progression, or death, 0.58; 95% CI, 0.36 to 0.93; P = 0.02). At 6 months, more cardiac and renal responses occurred in the daratumumab group than in the control group (41.5% vs. 22.2% and 53.0% vs. 23.9%, respectively). The four most common grade 3 or 4 adverse events were lymphopenia (13.0% in the daratumumab group and 10.1% in the control group), pneumonia (7.8% and 4.3%, respectively), cardiac failure (6.2% and 4.8%), and diarrhea (5.7% and 3.7%). Systemic administration-related reactions to daratumumab occurred in 7.3% of the patients. A total of 56 patients died (27 in the daratumumab group and 29 in the control group), most due to amyloidosis-related cardiomyopathy.Among patients with newly diagnosed AL amyloidosis, the addition of daratumumab to bortezomib, cyclophosphamide, and dexamethasone was associated with higher frequencies of hematologic complete response and survival free from major organ deterioration or hematologic progression. (Funded by Janssen Research and Development; ANDROMEDA ClinicalTrials.gov number, NCT03201965.).

Published
2021
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19. Daratumumab-Based Treatment for Immunoglobulin Light-Chain Amyloidosis

Author

Kastritis, E. Palladini, G. Minnema, M. C. Wechalekar, A. D. and Jaccard, A. Lee, H. C. Sanchorawala, V Gibbs, S. and Mollee, P. Venner, C. P. Lu, J. Schonland, S. Gatt, M. E. Suzuki, K. Kim, K. Cibeira, M. T. Beksac, M. and Libby, E. Valent, J. Hungria, V Wong, S. W. Rosenzweig, M. Bumma, N. Huart, A. Dimopoulos, M. A. Bhutani, D. and Waxman, A. J. Goodman, S. A. Zonder, J. A. Lam, S. Song, K. Hansen, T. Manier, S. Roeloffzen, W. Jamroziak, K. and Kwok, F. Shimazaki, C. Kim, J-S Crusoe, E. Ahmadi, T. Tran, N. P. Qin, X. Vasey, S. Y. Tromp, B. and Schecter, J. M. Weiss, B. M. Zhuang, S. H. Vermeulen, J. and Merlini, G. Comenzo, R. L. ANDROMEDA Trial Investigators

Abstract

Background Systemic immunoglobulin light-chain (AL) amyloidosis is characterized by deposition of amyloid fibrils of light chains produced by clonal CD38+ plasma cells. Daratumumab, a human CD38-targeting antibody, may improve outcomes for this disease. Methods We randomly assigned patients with newly diagnosed AL amyloidosis to receive six cycles of bortezomib, cyclophosphamide, and dexamethasone either alone (control group) or with subcutaneous daratumumab followed by single-agent daratumumab every 4 weeks for up to 24 cycles (daratumumab group). The primary end point was a hematologic complete response. Results A total of 388 patients underwent randomization. The median follow-up was 11.4 months. The percentage of patients who had a hematologic complete response was significantly higher in the daratumumab group than in the control group (53.3% vs. 18.1%) (relative risk ratio, 2.9; 95% confidence interval [CI], 2.1 to 4.1; P

Published
2021

27. Health-related quality of life after chemotherapy with or without rituximab in primary central nervous system lymphoma patients: results from a randomised phase III study

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, van der Meulen, M, Bakunina, K, Nijland, M, Minnema, M C, Cull, G, Stevens, W B C, Baars, J W, Mason, K D, Beeker, A, Beijert, M, Taphoorn, M J B, van den Bent, M J, Issa, S, Doorduijn, J K, Bromberg, J E C, Dirven, L, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, van der Meulen, M, Bakunina, K, Nijland, M, Minnema, M C, Cull, G, Stevens, W B C, Baars, J W, Mason, K D, Beeker, A, Beijert, M, Taphoorn, M J B, van den Bent, M J, Issa, S, Doorduijn, J K, Bromberg, J E C, and Dirven, L

Published
2020

28. Hoe behandel ik IgM-M-proteïne-gerelateerde AL-amyloïdose?

Author

Hoving, V., Kersten, M. J., Minnema, M. C., de Bruin, P. C., Vos, Josephine, CCA - Treatment and quality of life, CCA - Cancer biology and immunology, AII - Cancer immunology, Clinical Haematology, General Internal Medicine, and Graduate School

Published
2019

29. Monoclonal gammopathy of renal significance (mgrs): Histopathologic classification, diagnostic workup, and therapeutic options

Author

Amaador, K., Peeters, H., Minnema, M. C., Tri Q Nguyen, Dendooven, A., Vos, J. M. I., Croockewit, A. J., Donk, N. W. C. J., Jacobs, J. F. M., Wetzels, J. F. M., Sprangers, B., Abrahams, A. C., General Internal Medicine, Clinical Haematology, Graduate School, AII - Inflammatory diseases, and Hematology

Subjects
Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], Journal Article, Human medicine, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
Abstract

Monoclonal gammopathy of renal significance (MGRS) includes all kidney disorders caused by a monoclonal protein (M-protein) secreted by a small plasma cell clone or other B-cell clones in patients who do not meet the diagnostic criteria for multiple myeloma or other B-cell malignancies. The underlying disorder in patients with MGRS is generally consistent with monoclonal gammopathy of undetermined significance (MGUS). MGRS-associated kidney disorders are various and the list is still expanding. The kidney disorders can manifest as glomerular diseases, tubulopathies, and vascular involvement with varying clinical presentations. Diagnosis is often challenging because of the wide spectrum of MGRS, and it is difficult to establish a pathogenic link between the presence of the M-protein or serum free light chains and kidney diseases; further complicating accurate diagnosis is the high incidence of MGUS and/or kidney disorders, independent of MGRS, in elderly patients. However, MGRS can significantly impair kidney function. Because treatment can stop and also reverse kidney disease, early recognition is of great importance. A combined haematologic and nephrologic approach is crucial to establish the causative role of the M-protein in the pathogenesis of kidney disease. Clone-directed therapy, which may include autologous stem cell transplantation in eligible patients, often results in improved outcomes. In this review, we discuss the histopathologic classification of MGRS lesions, provide a renal and haematologic diagnostic workup, discuss treatment options for MGRS, and introduce a Benelux MGRS Working Group.

Published
2019

30. 'Transformation' from amyloid light chain amyloidosis to symptomatic multiple myeloma

Author

Rutten, K H G, Raymakers, R A P, and Minnema, M C

Subjects
multiple myeloma, Amyloidosis, plasma cell dyscrasia
Abstract

Amyloid light chain (AL) amyloidosis and multiple myeloma (MM) are both clonal plasma cell disorders, and may be concurrently present in patients. However, symptomatic MM seldom develops in patients with AL amyloidosis, while the other way around is common. With this case report, we discuss the difficulties in the differential diagnosis between AL amyloidosis and MM, and extend on the possible mechanisms involved in the development of these overlapping disorders. In addition, we provide clinicians with tools that may help improve their management and monitoring of such patients.

Published
2018

32. Cardiac amyloidosis : the need for early diagnosis

Author

Oerlemans, M. I.F.J., Rutten, K. H.G., Minnema, M. C., Raymakers, R. A.P., Asselbergs, F. W., de Jonge, Nicolaas, Oerlemans, M. I.F.J., Rutten, K. H.G., Minnema, M. C., Raymakers, R. A.P., Asselbergs, F. W., and de Jonge, Nicolaas

Published
2019

33. Monoclonal gammopathy of renal significance (MGRS) histopathologic classification, diagnostic workup, and therapeutic options

Author

Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, Abrahams, A C, Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, and Abrahams, A C

Published
2019

34. Cardiac amyloidosis: the need for early diagnosis

Author

Team Medisch, Circulatory Health, Secretariaat Hematologie, Externen Hematologie, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Oerlemans, M. I.F.J., Rutten, K. H.G., Minnema, M. C., Raymakers, R. A.P., Asselbergs, F. W., de Jonge, Nicolaas, Team Medisch, Circulatory Health, Secretariaat Hematologie, Externen Hematologie, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Oerlemans, M. I.F.J., Rutten, K. H.G., Minnema, M. C., Raymakers, R. A.P., Asselbergs, F. W., and de Jonge, Nicolaas

Published
2019

35. Monoclonal gammopathy of renal significance (MGRS) histopathologic classification, diagnostic workup, and therapeutic options

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Pathologie Pathologen staf, Circulatory Health, Pathologie Opleiding, Externen Hematologie, MKA/BT Onderzoek, MS Nefrologie, Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, Abrahams, A C, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Pathologie Pathologen staf, Circulatory Health, Pathologie Opleiding, Externen Hematologie, MKA/BT Onderzoek, MS Nefrologie, Amaador, K, Peeters, H, Minnema, M C, Nguyen, T Q, Dendooven, A, Vos, J M I, Croockewit, A J, van de Donk, N W C J, Jacobs, J F M, Wetzels, J F M, Sprangers, B, and Abrahams, A C

Published
2019

36. A phase II study of selinexor(KPT-330) combined with bortezomib and dexamethasone (SVD) for induction and consolidation for patients with progressive or refractory multiple myeloma: The selvedex trial

Author

Broijl, A, Asselbergs, E L, Minnema, M C, Lonergan, S, van der Holt, B, van de Donk, N, Zweegman, S, Sonneveld, P, Hematology, CCA - Cancer biology and immunology, CCA - Imaging and biomarkers, CCA - Treatment and quality of life, Anatomy and neurosciences, and General practice

Abstract

Selinexor is an oral selective exportin-1 (XPO-1) inhibitor that forces nuclear retention and activation of many tumor suppressor proteins (TSPs) and IkB and is active as monotherapy and combined with dexamethasone in multiple myeloma (MM). Addition of proteasome inhibitors to selinexor increases levels and activity of TSPs/IkB leading to synergistic MM cell death.AimsA dose escalating phase I/II study was performed in patients with progressive and/or refractory MM, evaluating feasibility (phase I) and efficacy (phase II) of selinexor at 3 dose levels combined with twice weekly (BIW) bortezomib and dexamethasone (SVd).MethodsThe maximum tolerated dose (MTD) and recommended dose level (RDL) were determined using a a3+3a dose escalation scheme. Patients could be included if they had received at least one prior anti-myeloma regimen, and were not refractory to bortezomib. Selinexor on days 1,8,15,22, bortezomib 1.3mg/m2 subcutaneously on days 1,4,8,11, dexamethasone 40mg on days 1,8,15,22 in a 28-days schedule.ResultsSeven patients were treated at the first selinexor dose level of 45mg/m2. The median number of prior treatments was 3 (range 2-7). Three patients were lenalidomide refractory during their last treatment. Two patients were deemed ineligible after inclusion, one patient had a transformation to plasma cell leukemia, one was bortezomib refractory. Two out of 5 eligible patients completed treatment as planned. Only one patient completed selinexor at the preplanned dose of 45mg/m2. Reasons for discontinuation were excessive toxicity(n=1), progressive disease(1), other reasons not specified(1). Two patients experienced a DLT, one grade 4 thrombocytopenia with epistaxis, one patient had an ischemic cerebrovascular event. Adverse events (AE) CTC grade 3-4 were observed in all treated patients (table 1). The study continued with a lower dose level of selinexor of 30mg/m2 with adjustment of bortezomib frequency to once weekly on days 4 and 11. The median number of prior treatments was 3 (range 1-7). Three patients were lenalidomide refractory. Two out of 6 patients who started treatment completed treatment as planned. Reasons for discontinuation were neuropathy grade 4(1), pneumonia(1), progressive disease(3). Six patients were treated of whom 4 patients experienced a DLT: hyponatremia grade 3(2), polyneuropathy grade 3(1), syncope grade 3(1).The study was stopped prematurely due to unacceptable toxicity observed in the 2 different dosing schedules of SVd. In the 45mg/m2 group 4 out of 5 (80%) patients achieved aPR, including 2 VGPR, and 1 sCR. Median follow-up (FU) was 27 months (range 0.6-31.5). Median PFS was 17 months, OS at 1 and 2 years was 100% and 75%, respectively. Four out of 6 (67%) patients in the 30mg/m2 group achieved aPR, including 1 VGPR; no CRs were seen. Median FU was 10.1 months (range 0.6-17.9). Median PFS was 10 months, 1 year OS was 75%.ConclusionWe found that both 30 and 45mg/m2 of selinexor in combination with either twice or once weekly bortezomib resulted in unacceptable toxicity. However, in those patients in whom the regimen was feasible we observed remarkable ORR, PFS and OS in this pretreated, predominantly lenalidomide-refractory MM population. This is consistent with results recently presented for once weekly SVd regimens. This regimen, which also showed high ORR and PFS, is currently being evaluated in the international Phase 3 randomized BOSTON study of SVd vs Vd (NCT 03110562).Session topic: 14. Myeloma and other monoclonal gammopathies - ClinicalKeyword(s): bortezomib, Multiple Myeloma, Refractory, TherapyCode of conduct/disclaimer available in General Terms Conditions

Published
2018

37. FEASIBILITY AND EFFICACY OF DOSE ADJUSTED MELPHALAN - PREDNISONE - BORTEZOMIB IN PATIENTS >= 75 YEARS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA; PRELIMINARY RESULTS OF THE PHASE II HOVON 123 STUDY

Author

Zweegman, S., Levin, M. -D., Klein, S. K., de Waal, E. G., Eeltink, C. M., Ypma, P. F., Dijk, A. C., Westerman, M., Deenik, W., Tanis, B., Slee-Valentijn, M. S., Minnema, M. C., Visser-Wisselaar, H., Stege, C., van de Donk, N. W., Nasserinejad, K., Sonneveld, P., CCA - Treatment and quality of life, Hematology, and Internal medicine

Published
2017

41. Onverwachte gevolgen van monoklonale gammopathie

Author

Smit, P M, Abrahams, A C, Schutgens, R G E, Notermans, N C, and Minnema, M C

Subjects
Adult, Medicine(all), Multiple Myeloma/blood, Monoclonal Gammopathy of Undetermined Significance/blood, Case Reports, Review, Middle Aged, immune system diseases, hemic and lymphatic diseases, Immunoglobulin G, Disease Progression, Journal Article, Humans, Female, cardiovascular diseases
Abstract

Monoclonal gammopathy of undetermined significance (MGUS) is a common haematological disorder characterized by the presence of a monoclonal protein (M-protein). MGUS is considered an asymptomatic 'innocent' pre-malignant precursor condition of - mostly - multiple myeloma, without indication for treatment. We present three cases illustrating that MGUS can lead to serious problems. The first patient, a 51-year-old female, presented with polyneuropathy due to anti-MAG antibodies related to IgM MGUS. The second patient, a 37-year-old female, presented with proteinuria due to immunotactoid glomerulopathy caused by renal monoclonal IgG deposition associated with MGUS. The third patient, a 55-year-old female, presented with severe bleeding caused by an aspecific inhibitor of the coagulation cascade as part of IgG MGUS. In conclusion, in addition to the risk of progression to an overt haematological malignancy, MGUS can lead to severe symptoms and significant organ damage by auto-antibody activity or pathological accumulation in tissues of its toxic M-protein.

Published
2017

43. Efficacy of host-dendritic cell vaccinations with or without minor histocompatibility antigen loading, combined with donor lymphocyte infusion in multiple myeloma patients

Author

Oostvogels, R., Kneppers, E., Minnema, M. C., Doorn, R. C., Franssen, L. E., Aarts, T., Emmelot, M. E., Spierings, E., Slaper-Cortenbach, I., Westinga, K., Goulmy, E., Lokhorst, H. M., Mutis, T., Oostvogels, R., Kneppers, E., Minnema, M. C., Doorn, R. C., Franssen, L. E., Aarts, T., Emmelot, M. E., Spierings, E., Slaper-Cortenbach, I., Westinga, K., Goulmy, E., Lokhorst, H. M., and Mutis, T.

Published
2017

45. Onverwachte gevolgen van monoklonale gammopathie

Author

Unit Opleiding Aios, MS Nefrologie, Circulatory Health, Poli Van Creveldkliniek Medisch, ZL Neuromusculaire Ziekten Medisch, Brain, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Smit, P M, Abrahams, A C, Schutgens, R G E, Notermans, N C, Minnema, M C, Unit Opleiding Aios, MS Nefrologie, Circulatory Health, Poli Van Creveldkliniek Medisch, ZL Neuromusculaire Ziekten Medisch, Brain, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Smit, P M, Abrahams, A C, Schutgens, R G E, Notermans, N C, and Minnema, M C

Published
2017

46. In search of the optimal platform for Post-Allogeneic SCT immunotherapy in relapsed multiple myeloma: a systematic review

Author

Unit Opleiding Aios, Regenerative Medicine and Stem Cells, MS Hematologie, Cancer, Infection & Immunity, CTI Kuball, Oostvogels, R, Uniken Venema, S M, de Witte, M, Raymakers, R, Kuball, J, Kröger, N., Minnema, M C, Unit Opleiding Aios, Regenerative Medicine and Stem Cells, MS Hematologie, Cancer, Infection & Immunity, CTI Kuball, Oostvogels, R, Uniken Venema, S M, de Witte, M, Raymakers, R, Kuball, J, Kröger, N., and Minnema, M C

Published
2017

47. Efficacy of host-dendritic cell vaccinations with or without minor histocompatibility antigen loading, combined with donor lymphocyte infusion in multiple myeloma patients

Author

Unit Opleiding Aios, MS Hematologie, Regenerative Medicine and Stem Cells, Infection & Immunity, CTI Kuball, CDL Celdiagnostiek, Apotheek Celtherapie Faciliteit, Externen Hematologie, CDL Cluster Onderzoek en Onderwijs, Oostvogels, R., Kneppers, E., Minnema, M. C., Doorn, R. C., Franssen, L. E., Aarts, T., Emmelot, M. E., Spierings, E., Slaper-Cortenbach, I., Westinga, K., Goulmy, E., Lokhorst, H. M., Mutis, T., Unit Opleiding Aios, MS Hematologie, Regenerative Medicine and Stem Cells, Infection & Immunity, CTI Kuball, CDL Celdiagnostiek, Apotheek Celtherapie Faciliteit, Externen Hematologie, CDL Cluster Onderzoek en Onderwijs, Oostvogels, R., Kneppers, E., Minnema, M. C., Doorn, R. C., Franssen, L. E., Aarts, T., Emmelot, M. E., Spierings, E., Slaper-Cortenbach, I., Westinga, K., Goulmy, E., Lokhorst, H. M., and Mutis, T.

Published
2017

48. Improving early diagnosis of pulmonary infections in patients with febrile neutropenia using low-dose chest computed tomography

Author

Afdeling Hematologie, Arts-assistenten Radiologie, Circulatory Health, MS Hematologie, Cancer, Infection & Immunity, MS Radiologie, Researchgr. Systems Radiology, Regenerative Medicine and Stem Cells, Gerritsen, M G, Willemink, M J, Pompe, E, van der Bruggen, T, van Rhenen, A, Lammers, J W J, Wessels, F, Sprengers, R W, de Jong, Pim, Minnema, M C, Afdeling Hematologie, Arts-assistenten Radiologie, Circulatory Health, MS Hematologie, Cancer, Infection & Immunity, MS Radiologie, Researchgr. Systems Radiology, Regenerative Medicine and Stem Cells, Gerritsen, M G, Willemink, M J, Pompe, E, van der Bruggen, T, van Rhenen, A, Lammers, J W J, Wessels, F, Sprengers, R W, de Jong, Pim, and Minnema, M C

Published
2017

49. Richtlijn behandeling multipel myeloom 2015

Author

Zweegman, S., Lokhorst, H. M., Levin, M. D., de Waal, E., Bos, G. M. J., Kersten, M. J., Croockewit, A., Ypma, P. F., Klein, S. K., Minnema, M. C., Sonneveld, P., Hematology, CCA - Innovative therapy, Amsterdam institute for Infection and Immunity, Cancer Center Amsterdam, and Clinical Haematology

Published
2015

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