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151. Ixazomib Plus Lenalidomide-Dexamethasone (IRd) in Relapsed/Refractory Multiple Myeloma (MM) Patients (Pts) - Effectiveness in Routine Clinical Practice Is Similar to the Efficacy in the Phase 3 Tourmaline-MM1 Trial: A Pooled Analysis from the Insight MM Observational Study and the Czech Registry of Monoclonal Gammopathies (RMG)

Author

Hajek, Roman Terpos, Evangelos Lee, Hans C. Chari, Ajai and Costello, Caitlin L. Puig, Noemi Leleu, Xavier Berdeja, Jesus G. Davies, Faith E. Weisel, Katja Usmani, Saad Z. and Hungria, Vania T. M. Boccadoro, Mario Rifkin, Robert M. and Zonder, Jeffrey A. Cook, Gordon Brozova, Lucie Barinova, Magda Ren, Kaili Cacioppo, Roxanne Skacel, Tomas Stull, Dawn Marie Maisnar, Vladimir

Published
2018

153. A Global Treatment Standard in Multiple Myeloma (MM) Remains Elusive Despite Advances in Care over 15 years: First Results from INSIGHT MM, the Largest Global Prospective, Observational MM Study

Author

Costello, Caitlin Boccadoro, Mario Usmani, Saad Z. Chari, Ajai Rifkin, Robert M. Abonour, Rafat Berdeja, Jesus and Cook, Gordon Goldschmidt, Hartmut Hajek, Roman Hungria, Vania Lee, Hans C. Leleu, Xavier Omel, Jim Spencer, Andrew Thompson, Michael A. Vela-Ojeda, Jorge Zonder, Jeffrey A. Puig, Noemi Aguaron, Alfonso Davies, Faith E. and Demers, Brittany Ren, Kaili Yu, Shawn Skacel, Tomas and Stull, Dawn Marie Terpos, Evangelos

Published
2018

155. Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients (Pts) with Relapsed or Refractory Multiple Myeloma (RRMM): Body Weight Subgroup Analysis of Columba

Author

Mateos, Maria-Victoria, primary, Usmani, Saad Z., additional, Grosicki, Sebastian, additional, Vorobyev, Vladimir I., additional, Spicka, Ivan, additional, Hungria, Vania T.M., additional, Korenkova, Sibirina, additional, Bahlis, Nizar, additional, Flogegard, Max, additional, Bladé, Joan, additional, Moreau, Philippe, additional, Kaiser, Martin F., additional, Iida, Shinsuke, additional, Laubach, Jacob P., additional, Masterson, Tara, additional, Lantz, Kristen Anne, additional, O'Rourke, Lisa, additional, Qin, Xiang, additional, Parasrampuria, Dolly A., additional, Heuck, Christoph, additional, Qi, Ming, additional, and Nahi, Hareth, additional

Published
2019
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156. Real-World (RW) Multiple Myeloma (MM) Patients (Pts) Remain Under-Represented in Clinical Trials Based on Standard Laboratory Parameters and Baseline Characteristics: Analysis of over 3,000 Pts from the Insight MM Global, Prospective, Observational Study

Author

Hungria, Vania T.M., primary, Lee, Hans C., additional, Abonour, Rafat, additional, Rifkin, Robert M., additional, Terpos, Evangelos, additional, Leleu, Xavier, additional, Costello, Caitlin L., additional, van Rhee, Frits, additional, Weisel, Katja C., additional, Puig, Noemi, additional, Berdeja, Jesus G., additional, Cook, Gordon, additional, Usmani, Saad Z., additional, Thompson, Michael A., additional, Boccadoro, Mario, additional, Zonder, Jeffrey A., additional, Spencer, Andrew, additional, Hajek, Roman, additional, Fanning, Suzanne R., additional, Boyd, Kevin, additional, Omel, Jim, additional, Armour, Mira, additional, Morgan, Kathryn E., additional, Patel, Ronak S., additional, Carlson, Gary L., additional, Ferrari, Renda H., additional, Stull, Dawn Marie, additional, Ren, Kaili, additional, Cherepanov, Dasha, additional, Pottala, James V., additional, and Chari, Ajai, additional

Published
2019
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157. T(11;14) and High BCL2 Expression Are Predictive Biomarkers of Response to Venetoclax in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma: Biomarker Analyses from the Phase 3 Bellini Study

Author

Harrison, Simon, primary, Cavo, Michele, primary, De La Rubia, Javier, primary, Popat, Rakesh, primary, Gasparetto, Cristina, primary, Hungria, Vania T.M., primary, Salwender, Hans, primary, Suzuki, Kenshi, primary, Kim, Inho, primary, Moreau, Philippe, primary, Spencer, Andrew, primary, O'Dwyer, Michael E, primary, Garg, Mamta, primary, Punnoose, Elizabeth A, primary, Jalaluddin, Muhammad, primary, Jia, Jia, primary, Yang, Xiaoqing, primary, Sun, Yan, primary, Ward, James E., primary, Maciag, Paulo C., primary, Ross, Jeremy A., primary, and Kumar, Shaji K., primary

Published
2019
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158. Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients with Relapsed or Refractory Multiple Myeloma: Columba Update

Author

Usmani, Saad Z., primary, Mateos, Maria-Victoria, additional, Nahi, Hareth, additional, Grosicki, Sebastian, additional, Vorobyev, Vladimir I., additional, Spicka, Ivan, additional, Hungria, Vania T.M., additional, Korenkova, Sibirina, additional, Flogegard, Max, additional, Bladé, Joan, additional, Moreau, Philippe, additional, Kaiser, Martin F., additional, Iida, Shinsuke, additional, Laubach, Jacob P., additional, Masterson, Tara, additional, Lantz, Kristen Anne, additional, O'Rourke, Lisa, additional, Heuck, Christoph, additional, Qin, Xiang, additional, Parasrampuria, Dolly A., additional, Qi, Ming, additional, and Bahlis, Nizar, additional

Published
2019
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159. Closing the Efficacy and Effectiveness Gap: Outcomes in Relapsed/Refractory Multiple Myeloma (RRMM) Patients (Pts) Treated with Ixazomib-Lenalidomide-Dexamethasone (IRd) in Routine Clinical Practice Remain Comparable to the Outcomes Reported in the Phase 3 Tourmaline-MM1 Study

Author

Hajek, Roman, primary, Minarik, Jiri, additional, Straub, Jan, additional, Pour, Ludek, additional, Jungova, Alexandra, additional, Berdeja, Jesus G., additional, Boccadoro, Mario, additional, Brožová, Lucie, additional, Spencer, Andrew, additional, van Rhee, Frits, additional, Vela-Ojeda, Jorge, additional, Thompson, Michael A., additional, Abonour, Rafat, additional, Chari, Ajai, additional, Cook, Gordon, additional, Costello, Caitlin L., additional, Davies, Faith E., additional, Hungria, Vania T.M., additional, Lee, Hans C., additional, Leleu, Xavier, additional, Puig, Noemi, additional, Rifkin, Robert M., additional, Terpos, Evangelos, additional, Usmani, Saad Z., additional, Weisel, Katja C., additional, Zonder, Jeffrey A., additional, Bařinová, Magda, additional, Kuhn, Matyáš, additional, Silar, Jiri, additional, Capkova, Lenka, additional, Galvez, Kenny, additional, Lu, Jin, additional, Skacel, Tomas, additional, Elliott, Jennifer, additional, Demers, Brittany, additional, Stull, Dawn Marie, additional, Ren, Kaili, additional, and Maisnar, Vladimir, additional

Published
2019
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160. Updated Analysis of Bellini, a Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author

Moreau, Philippe, primary, Harrison, Simon, additional, Cavo, Michele, additional, De La Rubia, Javier, additional, Popat, Rakesh, additional, Gasparetto, Cristina, additional, Hungria, Vania T.M., additional, Salwender, Hans, additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Gay, Francesca, additional, Mikala, Gábor, additional, Punnoose, Elizabeth A, additional, Hong, Wan-Jen, additional, Sood, Anjla, additional, Jalaluddin, Muhammad, additional, Ross, Jeremy A., additional, Ward, James E., additional, Maciag, Paulo C., additional, and Kumar, Shaji K., additional

Published
2019
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161. Subcutaneous Daratumumab Plus Standard Treatment Regimens in Patients with Multiple Myeloma across Lines of Therapy: Pleiades Study Update

Author

Chari, Ajai, primary, San-Miguel, Jesús, additional, McCarthy, Helen, additional, Suzuki, Kenshi, additional, Hungria, Vania T.M., additional, Sureda, Anna, additional, Perrot, Aurore, additional, Hulin, Cyrille, additional, Magen, Hila, additional, Iida, Shinsuke, additional, Maisnar, Vladimir, additional, Karlin, Lionel, additional, Pour, Ludek, additional, Parasrampuria, Dolly A., additional, Masterson, Tara, additional, Kosh, Michele, additional, Yang, Shiyi, additional, Delioukina, Maria L., additional, Qi, Ming, additional, Carson, Robin, additional, and Touzeau, Cyrille, additional

Published
2019
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162. Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) in First Relapse Patients (pts) with Multiple Myeloma (MM): Four-Year Update of Castor

Author

Weisel, Katja C., primary, Sonneveld, Pieter, additional, Mateos, Maria-Victoria, additional, Hungria, Vania T.M., additional, Spencer, Andrew, additional, Estell, Jane, additional, Barreto, Wolney G, additional, Corradini, Paolo, additional, Min, Chang-Ki, additional, Medvedova, Eva, additional, Krevvata, Maria, additional, Trivedi, Sonali, additional, Qin, Xiang, additional, Pei, Huiling, additional, Ukropec, Jon, additional, Kobos, Rachel, additional, Qi, Ming, additional, and Nooka, Ajay K, additional

Published
2019
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163. Comparison of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) with Standard of Care for Patients from Latin America with Newly Diagnosed Multiple Myeloma (NDMM) Who Were Transplant Ineligible: A Propensity Score Matching Analysis

Author

Hungria, Vania T.M., primary, Martinez-Banos, Deborah M., additional, Mateos, Maria-Victoria, additional, Dimopoulos, Meletios A., additional, Cavo, Michele, additional, Heeg, Bart, additional, Lam, Annette, additional, Machnicki, Gerardo, additional, He, Jianming, additional, and Fernandez, Mariana, additional

Published
2019
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164. Physical Function, Pain Severity, and Fatigue in Patients with Relapsed/Refractory Multiple Myeloma: Health-Related Quality of Life Results in Patients Receiving Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone

Author

Gasparetto, Cristina, primary, Popat, Rakesh, additional, Kumar, Shaji K., additional, Cavo, Michele, additional, de la Rubia, Javier, additional, Hungria, Vania T.M., additional, Salwender, Hans, additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Maciel, James, additional, Hsiao, Liang-Tsai, additional, Moreau, Philippe, additional, Harrison, Simon, additional, Jia, Jia, additional, Karve, Sudeep, additional, Ma, Esprit, additional, Devine, Jacob, additional, and Benjamin, Katy, additional

Published
2019
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165. A tale of two paradigms: fixed duration vs continuous therapy in routine clinical practice: An INSIGHT MM study analysis of duration of therapy

Author

Weisel, Katja, primary, Hungria, Vania, additional, Leleu, Xavier, additional, Lee, Hans, additional, Rifkin, Robert, additional, Costello, Caitlin, additional, Abonour, Rafat, additional, Chari, Ajai, additional, Puig, Noemi, additional, Berdeja, Jesus, additional, Cook, Gordon, additional, Thompson, Michael A., additional, Boccadoro, Mario, additional, Terpos, Evangelos, additional, Zonder, Jeffrey A., additional, Vela-Ojeda, Jorge, additional, Davies, Faith, additional, van Rhee, Frits, additional, Hajek, Roman, additional, Spencer, Andrew, additional, Omel, Jim, additional, Armour, Mira, additional, Stull, Dawn Marie, additional, Carlson, Gary, additional, Elliott, Jennifer, additional, Cherepanov, Dasha, additional, Ferrari, Renda, additional, Skacel, Tomas, additional, Ren, Kaili, additional, and Usmani, Saad, additional

Published
2019
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166. Subcutaneous (SC) Daratumumab (DARA) in Combination With Standard Multiple Myeloma (MM) Treatment Regimens: An Open-label, Multicenter Phase 2 Study (PLEIADES)

Author

Chari, Ajai, primary, Goldschmidt, Hartmut, additional, San-Miguel, Jesus, additional, McCarthy, Helen, additional, Suzuki, Kenshi, additional, Hungria, Vania, additional, Balari, Anna Sureda, additional, Perrot, Aurore, additional, Hulin, Cyrille, additional, Magen, Hila, additional, Iida, Shinsuke, additional, Maisnar, Vladimir, additional, Karlin, Lionel, additional, Pour, Ludek, additional, Parasrampuria, Dolly, additional, Masterson, Tara, additional, Kosh, Michele, additional, yang, shiyi, additional, Qi, Ming, additional, Carson, Robin, additional, and Moreau, Philippe, additional

Published
2019
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167. Greater Treatment Satisfaction in Patients Receiving Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) for Relapsed or Refractory Multiple Myeloma (RRMM): COLUMBA

Author

Usmani, Saad, primary, Mateos, Maria-Victoria, additional, Hungria, Vania, additional, Iida, Shinsuke, additional, Bahlis, Nizar J., additional, Nahi, Hareth, additional, Magen, Hila, additional, Cavo, Michele, additional, HULIN, Cyrille, additional, White, Darrell, additional, De Stefano, Valerio, additional, Slavcev, Mary, additional, Heuck, Christoph, additional, Qin, Xiang, additional, Masterson, Tara, additional, Lantz, Kristen, additional, and Gries, Katharine, additional

Published
2019
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168. Preliminary results of Daratumumab, cyclophosphamide, thalidomide and dexamethasone- A quadruplet intensified treatment to newly diagnosed multiple myeloma transplant eligible patients

Author

de Queiroz Crusoé, Edvan, primary, Santos, Juliana, additional, Santos, Allan, additional, Santos, Mariane Melo, additional, Salvino, Marco Aurelio, additional, Adorno, Elisangela, additional, Moura, Alessandro, additional, Fonseca, Cleverson Alves, additional, Queiroz, Sarah, additional, da Gloria Bomfim, Maria, additional, Nicanor, Jamile, additional, Santos, Herbert Henrique, additional, and Hungria, Vania, additional

Published
2019
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170. A Phase 3 Study of Venetoclax or Placebo in Combination with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author

Kumar, Shaji, primary, Harrison, Simon J., additional, Cavo, Michele, additional, Rubia, Javier DE.LA., additional, Popat, Rakesh, additional, Gasparetto, Cristina J., additional, Hungria, Vania, additional, Salwender, Hans J., additional, Suzuki, Kenshi, additional, Kim, Inho, additional, Punnoose, Elizabeth, additional, Hong, Wan-Jen, additional, Freise, Kevin J., additional, Sood, Anjla, additional, Jalaluddin, Muhammad, additional, Ross, Jeremy, additional, Ward, James E., additional, Maciag, Paulo, additional, and Moreau, Philippe, additional

Published
2019
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171. Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato‐Oncology (HOLA) Observational Study, 2008–2016

Author

Hungria, Vania Tietsche, primary, Martínez‐Baños, Deborah M., additional, Peñafiel, Christian R., additional, Miguel, Carlos E., additional, Vela‐Ojeda, Jorge, additional, Remaggi, Guillermina, additional, Duarte, Fernando B., additional, Cao, Carmen, additional, Cugliari, Maria S., additional, Santos, Telma, additional, Machnicki, Gerardo, additional, Fernandez, Mariana, additional, Grings, Mariana, additional, Ammann, Eric M., additional, Lin, Jennifer H., additional, Chen, Yen‐Wen, additional, Wong, Yu‐Ning, additional, and Barreyro, Paula, additional

Published
2019
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172. Efficacy and safety of daratumumab, bortezomib, and dexamethasone (D-Vd) in relapsed or refractory multiple myeloma (RRMM) based on cytogenetic risk: Updated subgroup analysis of CASTOR.

Author

Weisel, Katja, primary, Spencer, Andrew, additional, Lentzsch, Suzanne, additional, Avet-Loiseau, Herve, additional, Mark, Tomer M., additional, Spicka, Ivan, additional, Bosi, Alberto, additional, Hungria, Vania TM, additional, Cavo, Michele, additional, Lee, Je-Jung, additional, Nooka, Ajay K., additional, Quach, Hang, additional, Munder, Markus, additional, Beksac, Meral, additional, Sonneveld, Pieter, additional, Soong, David, additional, Ukropec, Jon, additional, Qi, Ming, additional, and Mateos, Maria-Victoria, additional

Published
2019
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173. Efficacy and safety of the randomized, open-label, non-inferiority, phase 3 study of subcutaneous (SC) versus intravenous (IV) daratumumab (DARA) administration in patients (pts) with relapsed or refractory multiple myeloma (RRMM): COLUMBA.

Author

Mateos, Maria-Victoria, primary, Nahi, Hareth, additional, Legiec, Wojciech, additional, Grosicki, Sebastian, additional, Vorobyev, Vladimir, additional, Spicka, Ivan, additional, Hungria, Vania TM, additional, Korenkova, Sibirina, additional, Bahlis, Nizar J., additional, Flogegard, Max, additional, Blade, Joan, additional, Moreau, Philippe, additional, Kaiser, Martin, additional, Iida, Shinsuke, additional, Laubach, Jacob, additional, Ahmadi, Tahamtan, additional, Parasrampuria, Dolly A., additional, Peng, Lixian, additional, Qi, Ming, additional, and Usmani, Saad Zafar, additional

Published
2019
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174. Bortezomib retreatment for relapsed and refractory multiple myeloma in real‐world clinical practice

Author

Hulin, Cyrille, primary, de la Rubia, Javier, additional, Dimopoulos, Meletios A., additional, Terpos, Evangelos, additional, Katodritou, Eirini, additional, Hungria, Vania, additional, De Samblanx, Hadewijch, additional, Stoppa, Anne‐Marie, additional, Aagesen, Jesper, additional, Sargin, Deniz, additional, Sioni, Anastasia, additional, Belch, Andrew, additional, Diels, Joris, additional, Olie, Robert A., additional, Robinson, Don, additional, Potamianou, Anna, additional, van de Velde, Helgi, additional, and Delforge, Michel, additional

Published
2018
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175. Subcutaneous daratumumab plus standard treatment regimens in patients with multiple myeloma across lines of therapy (PLEIADES): an open‐label Phase II study.

Author

Chari, Ajai, Rodriguez‐Otero, Paula, McCarthy, Helen, Suzuki, Kenshi, Hungria, Vania, Sureda Balari, Anna, Perrot, Aurore, Hulin, Cyrille, Magen, Hila, Iida, Shinsuke, Maisnar, Vladimir, Karlin, Lionel, Pour, Ludek, Parasrampuria, Dolly A., Masterson, Tara, Kosh, Michele, Yang, Shiyi, Delioukina, Maria, Qi, Ming, and Carson, Robin

Subjects
MULTIPLE myeloma, PLEIADES, BORTEZOMIB, CONFIDENCE intervals, DARATUMUMAB
Abstract

Summary: Daratumumab is a CD38‐targeting monoclonal antibody approved for intravenous (IV) infusion for multiple myeloma (MM). We describe the Phase II PLEIADES study of a subcutaneous formulation of daratumumab (DARA SC) in combination with standard‐of‐care regimens: DARA SC plus bortezomib/lenalidomide/dexamethasone (D‐VRd) for transplant‐eligible newly diagnosed MM (NDMM); DARA SC plus bortezomib/melphalan/prednisone (D‐VMP) for transplant‐ineligible NDMM; and DARA SC plus lenalidomide/dexamethasone (D‐Rd) for relapsed/refractory MM. In total, 199 patients were treated (D‐VRd, n = 67; D‐VMP, n = 67; D‐Rd, n = 65). The primary endpoints were met for all cohorts: the ≥very good partial response (VGPR) rate after four 21‐day induction cycles for D‐VRd was 71·6% [90% confidence interval (CI) 61·2–80·6%], and the overall response rates (ORRs) for D‐VMP and D‐Rd were 88·1% (90% CI 79·5–93·9%) and 90·8% (90% CI 82·6–95·9%). With longer median follow‐up for D‐VMP and D‐Rd (14·3 and 14·7 months respectively), responses deepened (ORR: 89·6%, 93·8%; ≥VGPR: 77·6%, 78·5%), and minimal residual disease–negativity (10‒5) rates were 16·4% and 15·4%. Infusion‐related reactions across all cohorts were infrequent (≤9·0%) and mild. The median DARA SC administration time was 5 min. DARA SC with standard‐of‐care regimens demonstrated comparable clinical activity to DARA IV–containing regimens, with low infusion‐related reaction rates and reduced administration time. [ABSTRACT FROM AUTHOR]

Published
2021
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176. Daratumumab, Bortezomib, and Dexamethasone for Multiple Myeloma

Author

Palumbo, Antonio, Chanan Khan, Asher, Weisel, Katja, Nooka, Ajay K., Masszi, Tamas, Beksac, Meral, Spicka, Ivan, Hungria, Vania, Munder, Markus, Mateos, Maria V., Mark, Tomer M., Ming, Qi, Schecter, Jordan, Amin, Himal, Qin, Xiang, Deraedt, William, Ahmadi, Tahamtan, Spencer, Andrew, Sonneveld, Pieter, Foa, Roberto, Castor, Investigators, Hematology, Palumbo, Antonio, Chanan Khan, Asher, Weisel, Katja, Nooka, Ajay K., Masszi, Tama, Beksac, Meral, Spicka, Ivan, Hungria, Vania, Munder, Marku, Mateos, Maria V., Mark, Tomer M., Ming, Qi, Schecter, Jordan, Amin, Himal, Qin, Xiang, Deraedt, William, Ahmadi, Tahamtan, Spencer, Andrew, Sonneveld, Pieter, and Cavo, Michele

Subjects
0301 basic medicine, Oncology, Male, Antigens, CD38, Drug Resistance, Dexamethasone, Ixazomib, Bortezomib, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, Medicine, Infusions, Intravenou, Elotuzumab, Infusions, Intravenous, Multiple myeloma, Isatuximab, Medicine (all), SLAMF7, Antibodies, Monoclonal, General Medicine, Middle Aged, 030220 oncology & carcinogenesis, Female, Intravenous, Multiple Myeloma, Human, medicine.drug, Adult, Aged, Disease-Free Survival, Drug Resistance, Neoplasm, Humans, Infusions, medicine.medical_specialty, Antibodies, 03 medical and health sciences, Internal medicine, Antigens, Antineoplastic Combined Chemotherapy Protocol, business.industry, Daratumumab, Interim analysis, medicine.disease, ADP-ribosyl Cyclase 1, Surgery, 030104 developmental biology, chemistry, Neoplasm, business, CD38
Abstract

Daratumumab, a human IgGκ monoclonal antibody that targets CD38, induces direct and indirect antimyeloma activity and has shown substantial efficacy as monotherapy in heavily pretreated patients with multiple myeloma, as well as in combination with bortezomib in patients with newly diagnosed multiple myeloma.In this phase 3 trial, we randomly assigned 498 patients with relapsed or relapsed and refractory multiple myeloma to receive bortezomib (1.3 mg per square meter of body-surface area) and dexamethasone (20 mg) alone (control group) or in combination with daratumumab (16 mg per kilogram of body weight) (daratumumab group). The primary end point was progression-free survival.A prespecified interim analysis showed that the rate of progression-free survival was significantly higher in the daratumumab group than in the control group; the 12-month rate of progression-free survival was 60.7% in the daratumumab group versus 26.9% in the control group. After a median follow-up period of 7.4 months, the median progression-free survival was not reached in the daratumumab group and was 7.2 months in the control group (hazard ratio for progression or death with daratumumab vs. control, 0.39; 95% confidence interval, 0.28 to 0.53; P0.001). The rate of overall response was higher in the daratumumab group than in the control group (82.9% vs. 63.2%, P0.001), as were the rates of very good partial response or better (59.2% vs. 29.1%, P0.001) and complete response or better (19.2% vs. 9.0%, P=0.001). Three of the most common grade 3 or 4 adverse events reported in the daratumumab group and the control group were thrombocytopenia (45.3% and 32.9%, respectively), anemia (14.4% and 16.0%, respectively), and neutropenia (12.8% and 4.2%, respectively). Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients in the daratumumab group; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of the patients), and in 98.2% of these patients, they occurred during the first infusion.Among patients with relapsed or relapsed and refractory multiple myeloma, daratumumab in combination with bortezomib and dexamethasone resulted in significantly longer progression-free survival than bortezomib and dexamethasone alone and was associated with infusion-related reactions and higher rates of thrombocytopenia and neutropenia than bortezomib and dexamethasone alone. (Funded by Janssen Research and Development; ClinicalTrials.gov number, NCT02136134.).

Published
2016

177. Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice

Author

Terpos, Evangelos, Katodritou, Eirini, de la Rubia, Javier, Hungria, Vania, Hulin, Cyrille, Roussou, Maria, Delforge, Michel, Bries, Greet, Stoppa, Anne-Marie, Aagesen, Jesper, Sargin, Deniz, Belch, Andrew, Ahlberg, Lucia, Diels, Joris, Olie, Robert A., Robinson, Don Jr., Spencer, Mike, Potamianou, Anna, van de Velde, Helgi, Dimopoulos, Meletios A., Terpos, Evangelos, Katodritou, Eirini, de la Rubia, Javier, Hungria, Vania, Hulin, Cyrille, Roussou, Maria, Delforge, Michel, Bries, Greet, Stoppa, Anne-Marie, Aagesen, Jesper, Sargin, Deniz, Belch, Andrew, Ahlberg, Lucia, Diels, Joris, Olie, Robert A., Robinson, Don Jr., Spencer, Mike, Potamianou, Anna, van de Velde, Helgi, and Dimopoulos, Meletios A.

Abstract

Objective: The efficacy and safety of bortezomib-based therapy for relapsed/refractory multiple myeloma (RRMM) in clinical trials may differ from the oncology practice experience. The electronic VELCADE (R) OBservational Study was designed to prospectively evaluate bortezomib for multiple myeloma (MM) in real-world medical practice. Method: Patients scheduled to receive intravenous bortezomib for MM were eligible. The primary objective was to evaluate clinical outcomes, including response, time to response, time to next therapy, treatment-free interval, progression-free survival (PFS), and overall survival (OS). Secondary objectives included safety and healthcare resource utilization. Results: In total, 873 patients with a median of two therapy lines prior to initiating bortezomib were included. The overall response rate (amp;gt;= partial response) was 69%, including 37% complete response/near-complete response. Median time to response was 1.8 months, median time to next therapy was 9.7 months, and median treatment-free interval was 7.9 months. After 22.6 months median follow-up, median PFS was 12.0 months and median OS was 36.1 months. The most common adverse events (AEs) were neuropathy not otherwise specified (19%), diarrhea NOS, and thrombocytopenia (each 17%); 230 (26%) patients discontinued bortezomib due to AEs. Of 689 (79%) patients without baseline peripheral neuropathy (PN), the rate of new-onset any-grade PN increased to 51% (12% grade 3/4) by cycle 8. Overall, 244 (28%) patients were hospitalized, 372 (43%) attended an outpatient visit, and 341 (39%) underwent a diagnostic/therapeutic procedure during bortezomib treatment. Conclusion: These prospective real-world data demonstrate the effectiveness and safety of bortezomib-based therapy for RRMM and confirm high response rates and long OS for this population., Funding Agencies|Janssen Global Services; Millennium Pharmaceuticals, Inc.

Published
2018
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178. IgM myeloma: A multicenter retrospective study of 134 patients

Author

Castillo, Jorge J., Jurczyszyn, Artur, Brozova, Lucie, Crusoe, Edvan, Czepiel, Jacek, Davila, Julio, Dispenzieri, Angela, Eveillard, Marion, Fiala, Mark A., Ghobrial, Irene M., Gozzetti, Alessandro, Gustine, Joshua N., Hajek, Roman, Hungria, Vania, Jarkovsky, Jiri, Jayabalan, David, Laubach, Jacob P., Lewicka, Barbara, Maisnar, Vladimir, Manasanch, Elisabet E., Moreau, Philippe, Morgan, Elizabeth A., Nahi, Hareth, Niesvizky, Ruben, Paba-Prada, Claudia, Pika, Tomas, Pour, Ludek, Reagan, John L., Richardson, Paul G., Shah, Jatin, Spicka, Ivan, Vij, Ravi, Waszczuk-Gajda, Anna, and Gertz, Morie A.

Subjects
Aged, 80 and over, Adult, Male, Aged, Biomarkers, Bone Marrow, Bone and Bones, Combined Modality Therapy, Female, Humans, Immunoglobulin M, Middle Aged, Multiple Myeloma, Plasma Cells, Retrospective Studies, Survival Analysis, Treatment Outcome, Hematology, 80 and over
Abstract

IgM myeloma is a rare hematologic malignancy for which the clinicopathological features and patient outcomes have not been extensively studied. We carried out a multicenter retrospective study in patients with diagnosis of IgM myeloma defined by10% marrow involvement by monoclonal plasma cells, presence of an IgM monoclonal paraproteinemia of any size, and anemia, renal dysfunction, hypercalcemia, lytic lesions and/or t(11;14) identified by FISH. A total of 134 patients from 20 centers were included in this analysis. The median age at diagnosis was 65.5 years with a male predominance (68%). Anemia, renal dysfunction, elevated calcium and skeletal lytic lesions were found in 37, 43, 19, and 70%, respectively. The median serum IgM level was 2,895 mg dL

Published
2017

179. Global, Prospective, Non-interventional, Observational Study of Disease Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma (MM) Patients (pts): The INSIGHT MM Study (NCT02761187)

Author

Rifkin, Robert Davies, Faith Palumbo, Antonio Zonder, Jeffrey A. Girnius, Saulius Costello, Caitlin Usmani, Saad and Berdeja, Jesus Omel, Jim Thompson, Michael Schwartz, J. Sanford Hajek, Roman Terpos, Evangelos Hungria, Vania and Mateos, Maria-Victoria Cook, Gordon Leleu, Xavier Spencer, Andrew Goldschmidt, Hartmut Seal, Brian

Published
2017

181. Multiple myeloma treatment patterns and clinical outcomes in the Latin America Haemato‐Oncology (HOLA) Observational Study, 2008–2016.

Author

Hungria, Vania Tietsche, Martínez‐Baños, Deborah M., Peñafiel, Christian R., Miguel, Carlos E., Vela‐Ojeda, Jorge, Remaggi, Guillermina, Duarte, Fernando B., Cao, Carmen, Cugliari, Maria S., Santos, Telma, Machnicki, Gerardo, Fernandez, Mariana, Grings, Mariana, Ammann, Eric M., Lin, Jennifer H., Chen, Yen‐Wen, Wong, Yu‐Ning, and Barreyro, Paula

Subjects
*MULTIPLE myeloma, *STEM cell transplantation, *SCIENTIFIC observation, *PROGRESSION-free survival, *MEDICAL records
Abstract

Summary: Limited data are available regarding contemporary multiple myeloma (MM) treatment practices in Latin America. In this retrospective cohort study, medical records were reviewed for a multinational cohort of 1103 Latin American MM patients (median age, 61 years) diagnosed in 2008–2015 who initiated first‐line therapy (LOT1). Of these patients, 33·9% underwent autologous stem cell transplantation (ASCT). During follow‐up, 501 (45·4%) and 129 (11·7%) patients initiated second‐ (LOT2) and third‐line therapy (LOT3), respectively. In the LOT1 setting, from 2008 to 2015, there was a decrease in the use of thalidomide‐based therapy, from 66·7% to 42·6%, and chemotherapy from, 20·2% to 5·9%, whereas use of bortezomib‐based therapy or bortezomib + thalidomide increased from 10·7% to 45·5%. Bortezomib‐based therapy and bortezomib + thalidomide were more commonly used in ASCT patients and in private clinics. In non‐ASCT and ASCT patients, median progression‐free survival (PFS) was 15·0 and 31·1 months following LOT1 and 10·9 and 9·5 months following LOT2, respectively. PFS was generally longer in patients treated with bortezomib‐based or thalidomide‐based therapy versus chemotherapy. These data shed light on recent trends in the management of MM in Latin America. Slower uptake of newer therapies in public clinics and poor PFS among patients with relapsed MM point to areas of unmet therapeutic need in Latin America. [ABSTRACT FROM AUTHOR]

Published
2020
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182. Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) in First Relapse Patients: Two-Year Update of Castor

Author

Mateos, Maria-Victoria, primary, Sonneveld, Pieter, additional, Hungria, Vania T. M., additional, Nooka, Ajay K, additional, Estell, Jane, additional, Barreto, Wolney G, additional, Corradini, Paolo, additional, Min, Chang-Ki, additional, Medvedova, Eva, additional, Weisel, Katja, additional, Chiu, Christopher, additional, Schecter, Jordan M., additional, Amin, Himal, additional, Qin, Xiang, additional, Qi, Ming, additional, and Spencer, Andrew, additional

Published
2018
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183. Results from a Phase II Study of Isatuximab As a Single Agent and in Combination with Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma

Author

Dimopoulos, Meletios A, primary, Bringhen, Sara, additional, Anttila, Pekka, additional, Capra, Marcelo, additional, Cavo, Michele, additional, Cole, Craig E., additional, Gasparetto, Cristina J, additional, Hungria, Vania T. M., additional, Jenner, Matthew, additional, Vorobyev, Vladimir, additional, Yanez Ruiz, Eduardo, additional, Yin, Jianyun, additional, Hamlett, Anthony, additional, and Vij, Ravi, additional

Published
2018
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184. Ixazomib Plus Lenalidomide-Dexamethasone (IRd) in Relapsed/Refractory Multiple Myeloma (MM) Patients (Pts) - Effectiveness in Routine Clinical Practice Is Similar to the Efficacy in the Phase 3 Tourmaline-MM1 Trial: A Pooled Analysis from the Insight MM Observational Study and the Czech Registry of Monoclonal Gammopathies (RMG)

Author

Hajek, Roman, primary, Terpos, Evangelos, additional, Lee, Hans C., additional, Chari, Ajai, additional, Costello, Caitlin L., additional, Puig, Noemi, additional, Leleu, Xavier, additional, Berdeja, Jesus G., additional, Davies, Faith E., additional, Weisel, Katja, additional, Usmani, Saad Z., additional, Hungria, Vania T. M., additional, Boccadoro, Mario, additional, Rifkin, Robert M, additional, Zonder, Jeffrey A, additional, Cook, Gordon, additional, Brožová, Lucie, additional, Bařinová, Magda, additional, Ren, Kaili, additional, Cacioppo, Roxanne, additional, Skacel, Tomas, additional, Stull, Dawn Marie, additional, and Maisnar, Vladimir, additional

Published
2018
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185. Transplant Status Does Not Impact the Selection of Induction Regimens for Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) in the Insight MM Prospective, Observational Study

Author

Usmani, Saad Z., primary, Hungria, Vania T. M., additional, Leleu, Xavier, additional, Lee, Hans C., additional, Davies, Faith E., additional, Costello, Caitlin L., additional, Rifkin, Robert M, additional, Weisel, Katja, additional, Chari, Ajai, additional, Puig, Noemi, additional, Boccadoro, Mario, additional, Cook, Gordon, additional, Berdeja, Jesus G., additional, Zonder, Jeffrey A, additional, Thompson, Michael A., additional, Abonour, Rafat, additional, Vela-Ojeda, Jorge, additional, Hajek, Roman, additional, Spencer, Andrew, additional, Omel, Jim, additional, Demers, Brittany, additional, Romanus, Dorothy, additional, Ren, Kaili, additional, Skacel, Tomas, additional, Stull, Dawn Marie, additional, and Terpos, Evangelos, additional

Published
2018
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186. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR

Author

Spencer, Andrew, primary, Lentzsch, Suzanne, additional, Weisel, Katja, additional, Avet-Loiseau, Hervé, additional, Mark, Tomer M., additional, Spicka, Ivan, additional, Masszi, Tamas, additional, Lauri, Birgitta, additional, Levin, Mark-David, additional, Bosi, Alberto, additional, Hungria, Vania, additional, Cavo, Michele, additional, Lee, Je-Jung, additional, Nooka, Ajay K., additional, Quach, Hang, additional, Lee, Cindy, additional, Barreto, Wolney, additional, Corradini, Paolo, additional, Min, Chang-Ki, additional, Scott, Emma C., additional, Chanan-Khan, Asher A., additional, Horvath, Noemi, additional, Capra, Marcelo, additional, Beksac, Meral, additional, Ovilla, Roberto, additional, Jo, Jae-Cheol, additional, Shin, Ho-Jin, additional, Sonneveld, Pieter, additional, Soong, David, additional, Casneuf, Tineke, additional, Chiu, Christopher, additional, Amin, Himal, additional, Qi, Ming, additional, Thiyagarajah, Piruntha, additional, Sasser, A. Kate, additional, Schecter, Jordan M., additional, and Mateos, Maria-Victoria, additional

Published
2018
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187. Bortezomib-based therapy for relapsed/refractory multiple myeloma in real-world medical practice

Author

Terpos, Evangelos, primary, Katodritou, Eirini, additional, de la Rubia, Javier, additional, Hungria, Vania, additional, Hulin, Cyrille, additional, Roussou, Maria, additional, Delforge, Michel, additional, Bries, Greet, additional, Stoppa, Anne-Marie, additional, Aagesen, Jesper, additional, Sargin, Deniz, additional, Belch, Andrew, additional, Ahlberg, Lucia, additional, Diels, Joris, additional, Olie, Robert A., additional, Robinson, Don, additional, Spencer, Mike, additional, Potamianou, Anna, additional, van de Velde, Helgi, additional, and Dimopoulos, Meletios A., additional

Published
2018
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188. A Global Treatment Standard in Multiple Myeloma (MM) Remains Elusive Despite Advances in Care over 15 years: First Results from INSIGHT MM, the Largest Global Prospective, Observational MM Study

Author

Costello, Caitlin, primary, Boccadoro, Mario, additional, Usmani, Saad Z., additional, Chari, Ajai, additional, Rifkin, Robert M., additional, Abonour, Rafat, additional, Berdeja, Jesus, additional, Cook, Gordon, additional, Goldschmidt, Hartmut, additional, Hajek, Roman, additional, Hungria, Vania, additional, Lee, Hans C., additional, Leleu, Xavier, additional, Omel, Jim, additional, Spencer, Andrew, additional, Thompson, Michael A., additional, Vela-Ojeda, Jorge, additional, Zonder, Jeffrey A., additional, Puig, Noemi, additional, Aguarón, Alfonso, additional, Davies, Faith E., additional, Demers, Brittany, additional, Ren, Kaili, additional, Yu, Shawn, additional, Skacel, Tomas, additional, Stull, Dawn Marie, additional, and Terpos, Evangelos, additional

Published
2018
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189. Secondary plasma cell leukemia: a multicenter retrospective study of 101 patients

Author

Jurczyszyn, Artur, primary, Castillo, Jorge J., additional, Avivi, Irit, additional, Czepiel, Jacek, additional, Davila, Julio, additional, Vij, Ravi, additional, Fiala, Mark A., additional, Gozzetti, Alessandro, additional, Grząśko, Norbert, additional, Milunovic, Vibor, additional, Hus, Iwona, additional, Mądry, Krzysztof, additional, Waszczuk-Gajda, Anna, additional, Usnarska-Zubkiewicz, Lidia, additional, Dębski, Jakub, additional, Atilla, Erden, additional, Beksac, Meral, additional, Mele, Giuseppe, additional, Sawicki, Waldemar, additional, Jayabalan, David, additional, Charliński, Grzegorz, additional, Gyula Szabo, Agoston, additional, Hajek, Roman, additional, Delforge, Michel, additional, Kopacz, Agnieszka, additional, Fantl, Dorotea, additional, Waage, Anders, additional, Crusoe, Edvan, additional, Hungria, Vania, additional, Richardson, Paul, additional, Laubach, Jacob, additional, Guerrero-Garcia, Thomas, additional, Liu, Jieqi, additional, and Vesole, David H., additional

Published
2018
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190. Daratumumab plus bortezomib-melphalan-prednisone (VMP) in elderly (≥75 y) patients (Pts) with newly diagnosed multiple myeloma (NDMM) ineligible for transplantation (ALCYONE).

Author

Cavo, Michele, primary, Iida, Shinsuke, additional, Blade, Joan, additional, Mateos, Maria-Victoria, additional, Lee, Je-Jung, additional, Garg, Mamta, additional, Hungria, Vania, additional, Beksac, Meral, additional, Spicka, Ivan, additional, Knop, Stefan, additional, Pour, Ludek, additional, Campbell, Philip, additional, Jakubowiak, Andrzej J., additional, Wang, Jianping, additional, Wroblewski, Susan, additional, Kobos, Rachel, additional, Qi, Ming, additional, and San-Miguel, Jesus, additional

Published
2018
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193. Global, Prospective, Non-Interventional, Observational Study of Presentation, Treatment Patterns, and Outcomes in Multiple Myeloma Patients: The Insight-MM Study

Author

Rifkin, Robert M. Davies, Faith E. Palumbo, Antonio Zonder, Jeffrey Girnius, Saulius K. Costello, Caitlin L. Usmani, Saad Z. Berdeja, Jesus G. Omel, Jim Thompson, Michael A. and Shah, Jatin Schwartz, J. Sanford Hajek, Roman Terpos, Evangelos Hungria, Vania Mateos, Maria-Victoria Cook, Gordon and Leleu, Xavier Spencer, Andrew Goldschmidt, Hartmut Seal, Brian Pashos, Chris L. Stull, Dawn Marie Romanus, Dorothy and Cacioppo, Roxanne Bell, Jill A. Yu, Shawn Luptakova, Katarina Niculescu, Liviu Noga, Stephen J. Skacel, Tomas and Chari, Ajai

Published
2016

196. Carfilzomib or bortezomib in relapsed or refractory multiple myeloma (ENDEAVOR): an interim overall survival analysis of an open-label, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, primary, Goldschmidt, Hartmut, additional, Niesvizky, Ruben, additional, Joshua, Douglas, additional, Chng, Wee-Joo, additional, Oriol, Albert, additional, Orlowski, Robert Z, additional, Ludwig, Heinz, additional, Facon, Thierry, additional, Hajek, Roman, additional, Weisel, Katja, additional, Hungria, Vania, additional, Minuk, Leonard, additional, Feng, Shibao, additional, Zahlten-Kumeli, Anita, additional, Kimball, Amy S, additional, and Moreau, Philippe, additional

Published
2017
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197. Similar survival outcomes in patients with biclonal versus monoclonal myeloma: a multi-institutional matched case-control study

Author

Jurczyszyn, Artur, primary, Gozzetti, Alessandro, additional, Gdula-Argasińska, Joanna, additional, Czepiel, Jacek, additional, Vij, Ravi, additional, Fiala, Mark, additional, Valls, Davila Julio, additional, Mądry, Krzysztof, additional, Waszczuk-Gajda, Anna, additional, Grosicki, Sebastian, additional, Barchnicka, Agnieszka, additional, Crusoe, Edvan, additional, Hungria, Vania, additional, Gentile, Massimo, additional, Mele, Giuseppe, additional, Ksieniewicz, Marcin, additional, Vesole, David H., additional, and Castillo, Jorge J., additional

Published
2017
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198. Panobinostat plus bortezomib and dexamethasone: impact of dose intensity and administration frequency on safety in the PANORAMA 1 trial

Author

San-Miguel, Jesús F., primary, Hungria, Vania T. M., additional, Yoon, Sung-Soo, additional, Beksac, Meral, additional, Dimopoulos, Meletios A., additional, Elghandour, Ashraf, additional, Jedrzejczak, Wieslaw W., additional, Guenther, Andreas, additional, Na Nakorn, Thanyaphong, additional, Siritanaratkul, Noppadol, additional, Schlossman, Robert L., additional, Hou, Jian, additional, Moreau, Philippe, additional, Lonial, Sagar, additional, Lee, Jae-Hoon, additional, Einsele, Hermann, additional, Salwender, Hans, additional, Sopala, Monika, additional, Redhu, Suman, additional, Paul, Sofia, additional, Corrado, Claudia, additional, and Richardson, Paul G., additional

Published
2017
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199. IgM myeloma: A multicenter retrospective study of 134 patients

Author

Castillo, Jorge J., primary, Jurczyszyn, Artur, additional, Brozova, Lucie, additional, Crusoe, Edvan, additional, Czepiel, Jacek, additional, Davila, Julio, additional, Dispenzieri, Angela, additional, Eveillard, Marion, additional, Fiala, Mark A., additional, Ghobrial, Irene M., additional, Gozzetti, Alessandro, additional, Gustine, Joshua N., additional, Hajek, Roman, additional, Hungria, Vania, additional, Jarkovsky, Jiri, additional, Jayabalan, David, additional, Laubach, Jacob P., additional, Lewicka, Barbara, additional, Maisnar, Vladimir, additional, Manasanch, Elisabet E., additional, Moreau, Philippe, additional, Morgan, Elizabeth A., additional, Nahi, Hareth, additional, Niesvizky, Ruben, additional, Paba‐Prada, Claudia, additional, Pika, Tomas, additional, Pour, Ludek, additional, Reagan, John L., additional, Richardson, Paul G., additional, Shah, Jatin, additional, Spicka, Ivan, additional, Vij, Ravi, additional, Waszczuk‐Gajda, Anna, additional, and Gertz, Morie A., additional

Published
2017
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