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1. P56 SURVIVAL BENEFIT OF BIRTAMIMAB IN MAYO STAGE IV AL AMYLOIDOSIS IN THE PHASE 3 VITAL STUDY WAS CONSISTENT ACROSS ALL KEY BASELINE VARIABLES

Author

Gertz, M., primary, Cohen, A., additional, Comenzo, R., additional, Kastritis, E., additional, Landau, H., additional, Libby, E., additional, Liedtke, M., additional, Sanchorawala, V., additional, Schönland, S., additional, Wechalekar, A., additional, Ando, Y., additional, Koh, Y., additional, Zonder, J., additional, Palladini, G., additional, Nie, C., additional, Karp, C., additional, Jin, Y., additional, Conrad, A., additional, Kinney, G., additional, and Merlini, G., additional

Published
2023
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2. Second primary malignancies in multiple myeloma: an overview and IMWG consensus

Author

Musto, P., Anderson, K.C., Attal, M., Richardson, P.G., Badros, A., Hou, J., Comenzo, R., Du, J., Durie, B.G.M., San Miguel, J., Einsele, H., Chen, W.M., Garderet, L., Pietrantuono, G., Hillengass, J., Kyle, R.A., Moreau, P., Lahuerta, J.J., Landgren, O., Ludwig, H., Larocca, A., Mahindra, A., Cavo, M., Mazumder, A., McCarthy, P.L., Nouel, A., Rajkumar, S.V., Reiman, A., Riva, E., Sezer, O., Terpos, E., Turesson, I., Usmani, S., Weiss, B.M., and Palumbo, A.

Published
2017
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6. 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

7. New drugs and novel mechanisms of action in multiple myeloma in 2013: a report from the International Myeloma Working Group (IMWG)

Author

Ocio, E M, Richardson, P G, Rajkumar, S V, Palumbo, A, Mateos, M V, Orlowski, R, Kumar, S, Usmani, S, Roodman, D, Niesvizky, R, Einsele, H, Anderson, K C, Dimopoulos, M A, Avet-Loiseau, H, Mellqvist, U-H, Turesson, I, Merlini, G, Schots, R, McCarthy, P, Bergsagel, L, Chim, C S, Lahuerta, J J, Shah, J, Reiman, A, Mikhael, J, Zweegman, S, Lonial, S, Comenzo, R, Chng, W J, Moreau, P, Sonneveld, P, Ludwig, H, Durie, B G M, and Miguel, J F S

Published
2014
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10. 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

12. Plasma cell leukemia: consensus statement on diagnostic requirements, response criteria and treatment recommendations by the International Myeloma Working Group

Author

Fernández de Larrea, C, Kyle, R A, Durie, B G M, Ludwig, H, Usmani, S, Vesole, D H, Hajek, R, San Miguel, J F, Sezer, O, Sonneveld, P, Kumar, S K, Mahindra, A, Comenzo, R, Palumbo, A, Mazumber, A, Anderson, K C, Richardson, P G, Badros, A Z, Caers, J, Cavo, M, LeLeu, X, Dimopoulos, M A, Chim, C S, Schots, R, Noeul, A, Fantl, D, Mellqvist, U-H, Landgren, O, Chanan-Khan, A, Moreau, P, Fonseca, R, Merlini, G, Lahuerta, J J, Bladé, J, Orlowski, R Z, and Shah, J J

Published
2013
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15. Management of treatment-emergent peripheral neuropathy in multiple myeloma

Author

Richardson, P G, Delforge, M, Beksac, M, Wen, P, Jongen, J L, Sezer, O, Terpos, E, Munshi, N, Palumbo, A, Rajkumar, S V, Harousseau, J L, Moreau, P, Avet-Loiseau, H, Lee, J H, Cavo, M, Merlini, G, Voorhees, P, Chng, W J, Mazumder, A, Usmani, S, Einsele, H, Comenzo, R, Orlowski, R, Vesole, D, Lahuerta, J J, Niesvizky, R, Siegel, D, Mateos, M-V, Dimopoulos, M, Lonial, S, Jagannath, S, Bladé, J, Miguel, J San, Morgan, G, Anderson, K C, Durie, B G M, and Sonneveld, P

Published
2012
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17. International myeloma working group (IMWG) consensus statement and guidelines regarding the current status of stem cell collection and high-dose therapy for multiple myeloma and the role of plerixafor (AMD 3100)

Author

Giralt, S, Stadtmauer, E A, Harousseau, J L, Palumbo, A, Bensinger, W, Comenzo, R L, Kumar, S, Munshi, N C, Dispenzieri, A, Kyle, R, Merlini, G, San Miguel, J, Ludwig, H, Hajek, R, Jagannath, S, Blade, J, Lonial, S, Dimopoulos, M A, Einsele, H, Barlogie, B, Anderson, K C, Gertz, M, Attal, M, Tosi, P, Sonneveld, P, Boccadoro, M, Morgan, G, Sezer, O, Mateos, M V, Cavo, M, Joshua, D, Turesson, I, Chen, W, Shimizu, K, Powles, R, Richardson, P G, Niesvizky, R, Rajkumar, S V, and Durie, B G M

Published
2009
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18. International Myeloma Working Group guidelines for the management of multiple myeloma patients ineligible for standard high-dose chemotherapy with autologous stem cell transplantation

Author

Palumbo, A, Sezer, O, Kyle, R, Miguel, J S, Orlowski, R Z, Moreau, P, Niesvizky, R, Morgan, G, Comenzo, R, Sonneveld, P, Kumar, S, Hajek, R, Giralt, S, Bringhen, S, Anderson, K C, Richardson, P G, Cavo, M, Davies, F, Bladé, J, Einsele, H, Dimopoulos, M A, Spencer, A, Dispenzieri, A, Reiman, T, Shimizu, K, Lee, J H, Attal, M, Boccadoro, M, Mateos, M, Chen, W, Ludwig, H, Joshua, D, Chim, J, Hungria, V, Turesson, I, Durie, B G M, and Lonial, S

Published
2009
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20. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders

Author

Dispenzieri, A, Kyle, R, Merlini, G, Miguel, J S, Ludwig, H, Hajek, R, Palumbo, A, Jagannath, S, Blade, J, Lonial, S, Dimopoulos, M, Comenzo, R, Einsele, H, Barlogie, B, Anderson, K, Gertz, M, Harousseau, J L, Attal, M, Tosi, P, Sonneveld, P, Boccadoro, M, Morgan, G, Richardson, P, Sezer, O, Mateos, M V, Cavo, M, Joshua, D, Turesson, I, Chen, W, Shimizu, K, Powles, R, Rajkumar, S V, and Durie, B G M

Published
2009
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25. Plasma cell leukemia: consensus statement on diagnostic requirements, response criteria and treatment recommendations by the International Myeloma Working Group

Author

de Larrea, Fernandez C, Kyle, R A, Durie, B GM, Ludwig, H, Usmani, S, Vesole, D H, Hajek, R, San Miguel, J F, Sezer, O, Sonneveld, P, Kumar, S K, Mahindra, A, Comenzo, R, Palumbo, A, Mazumber, A, Anderson, K C, Richardson, P G, Badros, A Z, Caers, J, Cavo, M, LeLeu, X, Dimopoulos, M A, Chim, C S, Schots, R, Noeul, A, Fantl, D, Mellqvist, U-H, Landgren, O, Chanan-Khan, A, Moreau, P, Fonseca, R, Merlini, G, Lahuerta, J J, Blade, J, Orlowski, R Z, and Shah, J J

Published
2013
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28. Risk-Adapted Melphalan with Stem Cell Transplant (Sct) and Adjuvant Dexamethasone (Dex) +/- Thalidomide (Thal) Achieves Low Treatmentrelated Mortality and High Hematologic Response Rates

Author

Clark, B, primary, Cohen, A, additional, Stubblefield, M, additional, Hassoun, H, additional, Zhou, P, additional, Comenzo, R, additional, Nimer, S, additional, Filippa, D, additional, Reich, L, additional, Teruya-Feldstein, J, additional, and Fleisher, M, additional

Published
2007
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32. Corrigendum: Second primary malignancies in multiple myeloma: an overview and IMWG consensus

Author

Musto, P, Anderson, K. C, Attal, M, Richardson, P. G, Badros, A, Hou, J, Comenzo, R, Du, J, Durie, B. G. M, San Miguel, J, Einsele, H, Chen, W. M, Garderet, L, Pietrantuono, G, Hillengass, J, Kyle, R. A, Moreau, P, Lahuerta, J. J, Landgren, O, Ludwig, H, Larocca, A, Mahindra, A, Cavo, M, Mazumder, A, McCarthy, P. L, Nouel, A, Rajkumar, S. V, Reiman, A, Riva, E, Sezer, O, Terpos, E, Turesson, I, Usmani, S, Weiss, B. M, Palumbo, A., Musto, P, Anderson, K. C, Attal, M, Richardson, P. G, Badros, A, Hou, J, Comenzo, R, Du, J, Durie, B. G. M, San Miguel, J, Einsele, H, Chen, W. M, Garderet, L, Pietrantuono, G, Hillengass, J, Kyle, R. A, Moreau, P, Lahuerta, J. J, Landgren, O, Ludwig, H, Larocca, A, Mahindra, A, Cavo, M, Mazumder, A, Mccarthy, P. L, Nouel, A, Rajkumar, S. V, Reiman, A, E, Riva, Sezer, O, Terpos, E, Turesson, I, Usmani, S, Weiss, B. M, and Palumbo, A.

Subjects
NA
Abstract

Erratum to: Annals of Oncology, Volume 28, Issue 2, 1 February 2017, Pages 228–245, https://doi.org/10.1093/annonc/mdw606

Published
2018

34. Prospective Evaluation of the Utility of the Serum Free Light Chain Assay (FLC), Clonal Ig Vl Gene Identification and Troponin I Levels in a Phase II Trial of Risk-Adapted Intravenous Melphalan with Adjuvant Thalidomide and Dexamethasone for Newly Diagnosed Untreated Patients with Systemic Al Amyloidosis

Author

Zhou, P, primary, Fleisher, M, additional, Hedvat, C, additional, Filippa, D, additional, Reich, L, additional, Teruya-Feldstein, J, additional, Drake, J, additional, Comenzo, R, additional, Costello, S, additional, Fircanis, S, additional, and Quinn, A, additional

Published
2004
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39. Second primary malignancies in multiple myeloma: An overview and IMWG consensus

Author

Musto, P. Anderson, K.C. Attal, M. Richardson, P.G. Badros, A. Hou, J. Comenzo, R. Du, J. Durie, B.G.M. San Miguel, J. Einsele, H. Chen, W.M. Garderet, L. Pietrantuono, G. Hillengass, J. Kyle, R.A. Moreau, P. Lahuerta, J.J. Landgren, O. Ludwig, H. Larocca, A. Mahindra, A. Cavo, M. Mazumder, A. McCarthy, P.L. Nouel, A. Rajkumar, S.V. Reiman, A. Riva, E. Sezer, O. Terpos, E. Turesson, I. Usmani, S. Weiss, B.M. Palumbo, A. on behalf of the International Myeloma Working Group

Abstract

Background: Therapeutic advancements following the introduction of autologous stem cell transplantation and 'novel' agents have significantly improved clinical outcomes for patients with multiple myeloma (MM). Increased life expectancy, however, has led to renewed concerns about the long-term risk of second primary malignancies (SPMs). This review outlines the most up-to-date knowledge of possible host-, disease-, and treatment-related risk factors for the development of SPMs in patients with MM, and provides practical recommendations to assist physicians. Design: A Panel of International Myeloma Working Group members reviewed the most relevant data published in the literature as full papers, or presented at meetings of the American Society of Clinical Oncology, American Society of Hematology, European Hematology Association, or International Myeloma Workshops, up to June 2016. Here, we present the recommendations of the Panel, based on this literature review. Results: Overall, the risk of SPMs in MM is low, multifactorial, and partially related to the length of patients' survival and MM intrinsic susceptibility. Studies suggest a significantly increased incidence of SPMs when lenalidomide is administered either following, or concurrently with, oral melphalan. Increased SPM incidence has also been reported with lenalidomide maintenance following high-dose melphalan, albeit to a lesser degree. In both cases, the risk of death from MM was significantly higher than the risk of death from SPMs, with lenalidomide possibly providing a survival benefit. No increase in SPM incidence was reported with lenalidomide plus dexamethasone (without melphalan), or with bortezomib plus oral melphalan, dexamethasone, or thalidomide.Conclusion: In general, the risk of SPMs should not alter the current therapeutic decision-making process in MM. However, regimens such as lenalidomide plus dexamethasone should be preferred to prolonged exposure to lenalidomide plus oral melphalan. SPM risk should be carefully discussed with the patient in the context of benefits and risks of different treatment options. © The Author 2016.

Published
2017

40. Second primary malignancies in multiple myeloma: an overview and IMWG consensus

Author

Musto, P., primary, Anderson, K.C., additional, Attal, M., additional, Richardson, P.G., additional, Badros, A., additional, Hou, J., additional, Comenzo, R., additional, Du, J., additional, Durie, B.G.M., additional, San Miguel, J., additional, Einsele, H., additional, Chen, W.M., additional, Garderet, L., additional, Pietrantuono, G., additional, Hillengass, J., additional, Kyle, R.A., additional, Moreau, P., additional, Lahuerta, J.J., additional, Landgren, O., additional, Ludwig, H., additional, Larocca, A., additional, Mahindra, A., additional, Cavo, M., additional, Mazumder, A., additional, McCarthy, P.L., additional, Nouel, A., additional, Rajkumar, S.V., additional, Reiman, A., additional, Riva, E., additional, Sezer, O., additional, Terpos, E., additional, Turesson, I., additional, Usmani, S., additional, Weiss, B.M., additional, and Palumbo, A., additional

Published
2018
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42. International myeloma working group recommendations for the diagnosis and management of myeloma-related renal impairment

Author

Dimopoulos, M.A. Sonneveld, P. Leung, N. Merlini, G. Ludwig, H. Kastritis, E. Goldschmidt, H. Joshua, D. Orlowski, R.Z. Powles, R. Vesole, D.H. Garderet, L. Einsele, H. Palumbo, A. Cavo, M. Richardson, P.G. Moreau, P. Miguel, J.S. Vincent Rajkumar, S. Durie, B.G.M. Terpos, E. Abildgaard, N. Abonour, R. Alsina, M. Anderson, K.C. Attal, M. Avet-Loiseau, H. Badros, A. Bahlis, N.J. Barlogie, B. Bataille, R. Beksaç, M. Belch, A. Ben-Yehuda, D. Bensinger, B. Leif Bergsagel, P. Bhutani, M. Bird, J. Bladé, J. Broijl, A. Boccadoro, M. Caers, J. Chanan-Khan, A. Chari, A. Chen, W.M. Chesi, M. Anthony Child, J. Chim, C.S. Chng, W.-J. Comenzo, R. Cook, G. Crowley, J. Crusoe, E. Dalton, W. Lee Moffitt, H. Davies, F. de la Rubia, J. de Souza, C. Delforge, M. Dhodapkar, M. Dispenzieri, A. Drach, J. Drake, M. Du, J. Dytfeld, D. Facon, T. Fantl, D. Fermand, J.-P. Fernández de Larrea, C. Fonseca, R. Gahrton, G. Garćia-Sanz, R. Gasparetto, C. Gertz, M. Ghobrial, I. Gibson, J. Gimsing, P. Giralt, S. Gu, J. Hajek, R. Hardan, I. Hari, P. Hata, H. Hattori, Y. Heffner, T. Hillengass, J. Ho, J. Hoering, A. Hoffman, J.E. Hou, J. Huang, J. Hungria, V. Ida, S. Jagannath, S. Jakubowiak, A.J. Johnsen, H.E. Jurczyszyn, A. Kaiser, M. Kaufman, J. Kawano, M. Korde, N. Kovacs, E. Krishnan, A. Kristinsson, S. Kröger, N. Kumar, S. Kyle, R.A. Kyriacou, C. Lacy, M. Lahuerta, J.J. Landgren, O. Larocca, A. Laubach, J. da Costa, F.L. Lee, J.-H. Leiba, M. Leleu, X. Lentzsch, S. Lokhorst, H. Lonial, S. Lu, J. Mahindra, A. Maiolino, A. Manasanch, E.E. Mark, T. Mateos, M.-V. Mazumder, A. McCarthy, P. Mehta, J. Mellqvist, U.-H. Mikhael, J. Morgan, G. Munshi, N. Nahi, H. Nawarawong, W. Niesvizky, R. Nouel, A. Novis, Y. Ocio, E. O'Dwyer, M. O'Gorman, P. Orfao, A. Otero, P.R. Paiva, B. Pavlovsky, S. Pilarski, L. Pratt, G. Qui, L. Raje, N. Reece, D. Reiman, A. Remaggi, G. Richter, J. Serra, E.R. Morales, A.R. Romeril, K.R. Roodman, D. Rosiñol, L. Rossi, A. Roussel, M. Russell, S. Schjesvold, F. Schots, R. Sevcikova, S. Sezer, O. Shah, J.J. Shimizu, K. Shustik, C. Siegel, D. Singhal, S. Spencer, A. Stadtmauer, E. Stewart, K. Tan, D. Terragna, C. Tosi, P. Tricot, G. Turesson, I. Usmani, S. Van Camp, B. Van de Donk, N. Van Ness, B. Van Riet, I. Broek, I.V. Vanderkerken, K. Vescio, R. Vij, R. Voorhees, P. Waage, A. Wang, M. Weber, D. Weiss, B.M. Westin, J. Wheatley, K. Zamagni, E. Zonder, J. Zweegman, S.

Abstract

Purpose: The aim of the International Myeloma Working Group was to develop practical recommendations for the diagnosis and management of multiple myeloma–related renal impairment (RI). Methods: Recommendations were based on published data through December 2015, and were developed using the system developed by the Grading of Recommendation, Assessment, Development, and Evaluation Working Group. Recommendations: All patients with myeloma at diagnosis and at disease assessment should have serum creatinine, estimated glomerular filtration rate, and electrolytes measurements as well as free light chain, if available, and urine electrophoresis of a sample from a 24-hour urine collection (grade A). The Chronic Kidney Disease Epidemiology Collaboration, preferably, or the Modification of Diet in Renal Disease formula should be used for the evaluation of estimated glomerular filtration rate in patients with stabilized serum creatinine (grade A). International Myeloma Working Group criteria for renal reversibility should be used (grade B). For the management of RI in patients with multiple myeloma, high fluid intake is indicated along with antimyeloma therapy (grade B). The use of high-cutoff hemodialysis membranes in combination with antimyeloma therapy can be considered (grade B). Bortezomib-based regimens remain the cornerstone of the management of myeloma-related RI (grade A). High-dose dexamethasone should be administered at least for the first month of therapy (grade B). Thalidomide is effective in patients with myeloma with RI, and no dose modifications are needed (grade B). Lenalidomide is effective and safe, mainly in patients with mild to moderate RI (grade B); for patients with severe RI or on dialysis, lena-lidomide should be given with close monitoring for hematologic toxicity (grade B) with dose reduction as needed. High-dose therapy with autologous stem cell transplantation (with melphalan 100 mg/m2 to 140 mg/m2) is feasible in patients with RI (grade C). Carfilzomib can be safely administered to patients with creatinine clearance > 15 mL/min, whereas ixazomib in combination with lenalidomide and dex-amethasone can be safely administered to patients with creatinine clearance > 30 mL/min (grade A). © 2016 by American Society of Clinical Oncology.

Published
2016

44. American Society of Blood and Marrow Transplantation, European Society of Blood and Marrow Transplantation, Blood and Marrow Transplant Clinical Trials Network, and International Myeloma Working Group Consensus Conference on Salvage Hematopoietic Cell Transplantation in Patients with Relapsed Multiple Myeloma

Author

Giralt, S. Garderet, L. Durie, B. Cook, G. Gahrton, G. Bruno, B. Hari, P. Lokhorst, H. McCarthy, P. Krishnan, A. Sonneveld, P. Goldschmidt, H. Jagannath, S. Barlogie, B. Mateos, M. Gimsing, P. Sezer, O. Mikhael, J. Lu, J. Dimopoulos, M. Mazumder, A. Palumbo, A. Abonour, R. Anderson, K. Attal, M. Blade, J. Bird, J. Cavo, M. Comenzo, R. de la Rubia, J. Einsele, H. Garcia-Sanz, R. Hillengass, J. Holstein, S. Johnsen, H.E. Joshua, D. Koehne, G. Kumar, S. Kyle, R. Leleu, X. Lonial, S. Ludwig, H. Nahi, H. Nooka, A. Orlowski, R. Rajkumar, V. Reiman, A. Richardson, P. Riva, E. San Miguel, J. Turreson, I. Usmani, S. Vesole, D. Bensinger, W. Qazilbash, M. Efebera, Y. Mohty, M. Gasparreto, C. Gajewski, J. LeMaistre, C.F. Bredeson, C. Moreau, P. Pasquini, M. Kroeger, N. Stadtmauer, E.

Subjects
surgical procedures, operative, immune system diseases, hemic and lymphatic diseases
Abstract

In contrast to the upfront setting in which the role of high-dose therapy with autologous hematopoietic cell transplantation (HCT) as consolidation of a first remission in patients with multiple myeloma (MM) is well established, the role of high-dose therapy with autologous or allogeneic HCT has not been extensively studied in MM patients relapsing after primary therapy. The International Myeloma Working Group together with the Blood and Marrow Transplant Clinical Trials Network, the American Society of Blood and Marrow Transplantation, and the European Society of Blood and Marrow Transplantation convened a meeting of MM experts to: (1) summarize current knowledge regarding the role of autologous or allogeneic HCT in MM patients progressing after primary therapy, (2) propose guidelines for the use of salvage HCT in MM, (3) identify knowledge gaps, (4) propose a research agenda, and (5) develop a collaborative initiative to move the research agenda forward. After reviewing the available data, the expert committee came to the following consensus statement for salvage autologous HCT: (1) In transplantation-eligible patients relapsing after primary therapy that did NOT include an autologous HCT, high-dose therapy with HCT as part of salvage therapy should be considered standard; (2) High-dose therapy and autologous HCT should be considered appropriate therapy for any patients relapsing after primary therapy that includes an autologous HCT with initial remission duration of more than 18 months; (3) High-dose therapy and autologous HCT can be used as a bridging strategy to allogeneic HCT; (4) The role of postsalvage HCT maintenance needs to be explored in the context of well-designed prospective trials that should include new agents, such as monoclonal antibodies, immune-modulating agents, and oral proteasome inhibitors; (5) Autologous HCT consolidation should be explored as a strategy to develop novel conditioning regimens or post-HCT strategies in patients with short (less than 18 months remissions) after primary therapy; and (6) Prospective randomized trials need to be performed to define the role of salvage autologous HCT in patients with MM relapsing after primary therapy comparing it to "best non-HCT" therapy. The expert committee also underscored the importance of collecting enough hematopoietic stem cells to perform 2 transplantations early in the course of the disease. Regarding allogeneic HCT, the expert committee agreed on the following consensus statements: (1) Allogeneic HCT should be considered appropriate therapy for any eligible patient with early relapse (less than 24 months) after primary therapy that included an autologous HCT and/or high-risk features (ie, cytogenetics, extramedullary disease, plasma cell leukemia, or high lactate dehydrogenase); (2) Allogeneic HCT should be performed in the context of a clinical trial if possible; (3) The role of postallogeneic HCT maintenance therapy needs to be explored in the context of well-designed prospective trials; and (4) Prospective randomized trials need to be performed to define the role salvage allogeneic HCT in patients with MM relapsing after primary therapy. © 2015 American Society for Blood and Marrow Transplantation.

Published
2015

45. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib:A multicenter international myeloma working group study

Author

Kumar S. K., Lee J. H., Lahuerta J. J., Morgan G., Richardson P. G., Crowley J., Haessler J., Feather J., Hoering A., Moreau P., LeLeu X., Hulin C., Klein S. K., Sonneveld P., Siegel D., Bladé J., Goldschmidt H., Jagannath S., Miguel J. S., Orlowski R., Palumbo A., Sezer O., Rajkumar S. V., Durie B. G. International Myeloma Working Group Abildgaard N, Abonour R, Alexanian R, Alsina M, Anderson KC, Attal M, Avet Loiseau H, Badros A, Baris D, Barlogie B, Bataille R, Beksaç M, Belch A, Ben Yehuda D, Bensinger B, Bergsagel PL, Bird J, Bladé J, Boccadoro M, Chanan Khan A, Chen WM, Child T, Chim J, Chng WJ, Comenzo R, Crowley J, Dalton W, Davies F, de Souza C, Delforge M, Dimopoulos M, Dispenzieri A, Drach J, Drake M, Durie BG, Einsele H, Facon T, Fantl D, Fermand JP, Fonseca R, Gahrton G, García Sanz R, Gasparetto C, Gertz M, Gibson J, Giralt S, Goldschmidt H, Greipp P, Hajek R, Hardan I, Hari P, Harousseau JL, Hata H, Hattori Y, Heffner T, Ho J, Hungria V, Ida S, Jacobs P, Jagannath S, Johnsen HE, Jian H, Joshua D, Jurczyszyn A, Kawano M, Kröger N, Kumar S, Kyle RA, Lacy M, Lahuerta JJ, Landgren O, Laubach J, Lee JH, LeLeu X, Lentzsch S, Lokhorst H, Lonial S, Ludwig H, Maiolino A, Mateos M, Mehta J, Mellqvist UH, Merlini G, Mikhael J, Morales AR, Moreau P, Morgan G, Nahi H, Munshi N, Niesvizky R, Nouel A, Novis Y, Orlowski R, Palumbo A, Pavlovsky S, Pilarski L, Powles R, Raje N, Rajkumar SV, Reece D, Reiman T, Richardson PG, Roodman D, Rosiñol L, San Miguel J, Sezer O, Shah JJ, Shaughnessy J, Shimizu K, Shustik C, Siegel D, Singhal S, Sonneveld P, Spencer A, Stadtmauer E, Stewart K, Terpos E, Tosi P, Tricot G, Turesson I, Van Camp B, Van Ness B, Van Riet I, Vande Broek I, Vanderkerken K, Vescio R, Vesole D, Waage A, Wang M, Weber D, Westin J, Wheatley K, Zonder J., CAVO, MICHELE, Kumar S.K., Lee J.H., Lahuerta J.J., Morgan G., Richardson P.G., Crowley J., Haessler J., Feather J., Hoering A., Moreau P., LeLeu X., Hulin C., Klein S.K., Sonneveld P., Siegel D., Bladé J., Goldschmidt H., Jagannath S., Miguel J.S., Orlowski R., Palumbo A., Sezer O., Rajkumar S.V., Durie B.G. International Myeloma Working Group Abildgaard N, Abonour R, Alexanian R, Alsina M, Anderson KC, Attal M, Avet-Loiseau H, Badros A, Baris D, Barlogie B, Bataille R, Beksaç M, Belch A, Ben-Yehuda D, Bensinger B, Bergsagel PL, Bird J, Bladé J, Boccadoro M, Cavo M, Chanan-Khan A, Chen WM, Child T, Chim J, Chng WJ, Comenzo R, Crowley J, Dalton W, Davies F, de Souza C, Delforge M, Dimopoulos M, Dispenzieri A, Drach J, Drake M, Durie BG, Einsele H, Facon T, Fantl D, Fermand JP, Fonseca R, Gahrton G, García-Sanz R, Gasparetto C, Gertz M, Gibson J, Giralt S, Goldschmidt H, Greipp P, Hajek R, Hardan I, Hari P, Harousseau JL, Hata H, Hattori Y, Heffner T, Ho J, Hungria V, Ida S, Jacobs P, Jagannath S, Johnsen HE, Jian H, Joshua D, Jurczyszyn A, Kawano M, Kröger N, Kumar S, Kyle RA, Lacy M, Lahuerta JJ, Landgren O, Laubach J, Lee JH, LeLeu X, Lentzsch S, Lokhorst H, Lonial S, Ludwig H, Maiolino A, Mateos M, Mehta J, Mellqvist UH, Merlini G, Mikhael J, Morales AR, Moreau P, Morgan G, Nahi H, Munshi N, Niesvizky R, Nouel A, Novis Y, Orlowski R, Palumbo A, Pavlovsky S, Pilarski L, Powles R, Raje N, Rajkumar SV, Reece D, Reiman T, Richardson PG, Roodman D, Rosiñol L, San Miguel J, Sezer O, Shah JJ, Shaughnessy J, Shimizu K, Shustik C, Siegel D, Singhal S, Sonneveld P, Spencer A, Stadtmauer E, Stewart K, Terpos E, Tosi P, Tricot G, Turesson I, Van Camp B, Van Ness B, Van Riet I, Vande Broek I, Vanderkerken K, Vescio R, Vesole D, Waage A, Wang M, Weber D, Westin J, Wheatley K, Zonder J., and Hematology

Subjects
Adult, Male, Oncology, Cancer Research, medicine.medical_specialty, NATURAL HISTORY, Antineoplastic Agents, Context (language use), RELAPSE, Article, Recurrence, Internal medicine, medicine, Humans, Immunologic Factors, Elotuzumab, Survival analysis, Multiple myeloma, Aged, Aged, 80 and over, Isatuximab, Bortezomib, business.industry, Hematology, Middle Aged, Pomalidomide, medicine.disease, Survival Analysis, Surgery, Regimen, SURVIVAL, Disease Progression, Female, Multiple Myeloma, business, medicine.drug
Abstract

Promising new drugs are being evaluated for treatment of multiple myeloma (MM), but their impact should be measured against the expected outcome in patients failing current therapies. However, the natural history of relapsed disease in the current era remains unclear. We studied 286 patients with relapsed MM, who were refractory to bortezomib and were relapsed following, refractory to or ineligible to receive, an IMiD (immunomodulatory drug), had measurable disease, and ECOG PS of 0, 1 or 2. The date patients satisfied the entry criteria was defined as time zero (T-0). The median age at diagnosis was 58 years, and time from diagnosis to T-0 was 3.3 years. Following T-0, 213 (74%) patients had a treatment recorded with one or more regimens (median = 1; range 0-8). The first regimen contained bortezomib in 55 (26%) patients and an IMiD in 70 (33%). A minor response or better was seen to at least one therapy after T0 in 94 patients (44%) including >= partial response in 69 (32%). The median overall survival and event-free survival from T-0 were 9 and 5 months, respectively. This study confirms the poor outcome, once patients become refractory to current treatments. The results provide context for interpreting ongoing trials of new drugs. Leukemia (2012) 26, 149-157; doi:10.1038/leu.2011.196; published online 29 July 2011

Published
2012

46. New drugs and novel mechanisms of action in multiple myeloma in 2013: A report from the International Myeloma Working Group (IMWG)

Author

Ocio, E.M. Richardson, P.G. Rajkumar, S.V. Palumbo, A. Mateos, M.V. Orlowski, R. Kumar, S. Usmani, S. Roodman, D. Niesvizky, R. Einsele, H. Anderson, K.C. Dimopoulos, M.A. Avet-Loiseau, H. Mellqvist, U.-H. Turesson, I. Merlini, G. Schots, R. Mccarthy, P. Bergsagel, L. Chim, C.S. Lahuerta, J.J. Shah, J. Reiman, A. Mikhael, J. Zweegman, S. Lonial, S. Comenzo, R. Chng, W.J. Moreau, P. Sonneveld, P. Ludwig, H. Durie, B.G.M. Miguel, J.F.S.

Abstract

Treatment in medical oncology is gradually shifting from the use of nonspecific chemotherapeutic agents toward an era of novel targeted therapy in which drugs and their combinations target specific aspects of the biology of tumor cells. Multiple myeloma (MM) has become one of the best examples in this regard, reflected in the identification of new pathogenic mechanisms, together with the development of novel drugs that are being explored from the preclinical setting to the early phases of clinical development. We review the biological rationale for the use of the most important new agents for treating MM and summarize their clinical activity in an increasingly busy field. First, we discuss data from already approved and active agents (including second- and third-generation proteasome inhibitors (PIs), immunomodulatory agents and alkylators). Next, we focus on agents with novel mechanisms of action, such as monoclonal antibodies (MoAbs), cell cycle-specific drugs, deacetylase inhibitors, agents acting on the unfolded protein response, signaling transduction pathway inhibitors and kinase inhibitors. Among this plethora of new agents or mechanisms, some are specially promising: anti-CD38 MoAb, such as daratumumab, are the first antibodies with clinical activity as single agents in MM. Moreover, the kinesin spindle protein inhibitor Arry-520 is effective in monotherapy as well as in combination with dexamethasone in heavily pretreated patients. Immunotherapy against MM is also being explored, and probably the most attractive example of this approach is the combination of the anti-CS1 MoAb elotuzumab with lenalidomide and dexamethasone, which has produced exciting results in the relapsed/refractory setting. © 2014 Macmillan Publishers Limited.

Published
2014

48. Safety and efficacy of carfilzomib (CFZ) in previously-treated systemic light-chain (AL) amyloidosis

Author

Cohen, A.D., primary, Liedtke, M., additional, Scott, E.C., additional, Kaufman, J.L., additional, Landau, H., additional, Vesole, D.H., additional, Gasparetto, C., additional, Lentzsch, S., additional, Gomes, C.L., additional, Rosenzweig, M., additional, Sanchorawala, V., additional, Smith, D.D., additional, Comenzo, R., additional, and Durie, B., additional

Published
2015
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49. Plasma cell leukemia: Consensus statement on diagnostic requirements, response criteria and treatment recommendations by the International Myeloma Working Group

Author

Fernández De Larrea, C. Kyle, R.A. Durie, B.G.M. Ludwig, H. Usmani, S. Vesole, D.H. Hajek, R. San Miguel, J.F. Sezer, O. Sonneveld, P. Kumar, S.K. Mahindra, A. Comenzo, R. Palumbo, A. Mazumber, A. Anderson, K.C. Richardson, P.G. Badros, A.Z. Caers, J. Cavo, M. Leleu, X. Dimopoulos, M.A. Chim, C.S. Schots, R. Noeul, A. Fantl, D. Mellqvist, U.-H. Landgren, O. Chanan-Khan, A. Moreau, P. Fonseca, R. Merlini, G. Lahuerta, J.J. Bladé, J. Orlowski, R.Z. Shah, J.J.

Abstract

Plasma cell leukemia (PCL) is a rare and aggressive variant of myeloma characterized by the presence of circulating plasma cells. It is classified as either primary PCL occurring at diagnosis or as secondary PCL in patients with relapsed/refractory myeloma. Primary PCL is a distinct clinic-pathological entity with different cytogenetic and molecular findings. The clinical course is aggressive with short remissions and survival duration. The diagnosis is based upon the percentage (≥20%) and absolute number (≥2 × 10 9/l) of plasma cells in the peripheral blood. It is proposed that the thresholds for diagnosis be re-examined and consensus recommendations are made for diagnosis, as well as, response and progression criteria. Induction therapy needs to begin promptly and have high clinical activity leading to rapid disease control in an effort to minimize the risk of early death. Intensive chemotherapy regimens and bortezomib-based regimens are recommended followed by high-dose therapy with autologous stem cell transplantation if feasible. Allogeneic transplantation can be considered in younger patients. Prospective multicenter studies are required to provide revised definitions and better understanding of the pathogenesis of PCL. © 2013 Macmillan Publishers Limited All rights reserved.

Published
2013

50. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib

Author

Kumar, Sk, Lee, Jh, Lahuerta, Jj, Morgan, G, Richardson, Pg, Crowley, J, Haessler, J, Feather, J, Hoering, A, Moreau, P, Leleu, X, Hulin, C, Klein, Sk, Sonneveld, P, Siegel, D, Bladé, J, Goldschmidt, H, Jagannath, S, Miguel, Js, Orlowski, R, Palumbo, Antonio, Sezer, O, Rajkumar, Sv, Durie, Bg, on behalf of the International Myeloma Working Group, International Myeloma Working Group, Abildgaard, N, Abonour, R, Alexanian, R, Alsina, M, Anderson, Kc, Attal, M, Avet Loiseau, H, Badros, A, Baris, D, Barlogie, B, Bataille, R, Beksaç, M, Belch, A, Ben Yehuda, D, Bensinger, B, Leif Bergsagel, P, Bird, J, Boccadoro, M, Cavo, M, Chanan Khan, A, Ming Chen, W, Child, T, Chim, J, Chng, Wj, Comenzo, R, Dalton, W, Davies, F, de Souza, C, Delforge, M, Dimopoulos, M, Dispenzieri, A, Drach, J, Drake, M, Einsele, H, Facon, T, Fantl, D, Fermand, Jp, Fonseca, R, Gahrton, G, García Sanz, R, Gasparetto, C, Gertz, M, Gibson, J, Giralt, S, Greipp, P, Hajek, R, Hardan, I, Hari, P, Harousseau, Jl, Hata, H, Hattori, Y, Heffner, T, Ho, J, Hungria, V, Ida, S, Jacobs, P, Johnsen, H, Jian, H, Joshua, D, Jurczyszyn, A, Kawano, M, Kröger, N, Kumar, S, Kyle, Ra, Lacy, M, Landgren, O, Laubach, J, Lentzsch, S, Lokhorst, H, Lonial, S, Ludwig, H, Maiolino, A, Mateos, M, Mehta, J, Mellqvist, Uh, Merlini, G, Mikhael, J, Morales, Ar, Nari, H, Munshi, N, Niesvizky, R, Nouel, A, Novis, Y, Palumbo, A, Pavlovsky, S, Pilarski, L, Powles, R, Raje, N, Vincent Rajkumar, S, Reece, D, Reiman, T, Roodman, D, Rosiñol, L, Shah, Jj, Shaughnessy, J, Shimizu, K, Shustik, C, Singhal, S, Spencer, A, Stadtmauer, E, Stewart, K, Terpos, E, Tosi, P, Tricot, G, Turesson, I, Van Camp, B, Van Ness, B, Van Riet, I, Broek, Iv, Vanderkerken, K, Vescio, R, Vesole, D, Waage, A, Wang, M, Weber, D, Westin, J, Wheatley, K, and Zonder, J.

Published
2012

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