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1. Daratumumab plus lenalidomide and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma: frailty subgroup analysis of MAIA

Author

Facon, Thierry, Cook, Gordon, Usmani, Saad Z., Hulin, Cyrille, Kumar, Shaji, Plesner, Torben, Touzeau, Cyrille, Bahlis, Nizar J., Basu, Supratik, Nahi, Hareth, Goldschmidt, Hartmut, Quach, Hang, Mohty, Mohamad, Venner, Christopher P., Weisel, Katja, Raje, Noopur, Hebraud, Benjamin, Belhadj-Merzoug, Karim, Benboubker, Lotfi, Decaux, Olivier, Manier, Salomon, Caillot, Denis, Ukropec, Jon, Pei, Huiling, Van Rampelbergh, Rian, Uhlar, Clarissa M., Kobos, Rachel, and Zweegman, Sonja

Published
2022
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2. Real-world outcomes with novel therapies in relapsed/refractory diffuse large B-cell lymphoma.

Author

Crombie, Jennifer L., Jun, Monika, Wang, Tongsheng, Mutebi, Alex, Wang, Anthony, Chhibber, Anindit, Kamalakar, Rajesh, Ukropec, Jon, Blaedel, Julie, and Kalsekar, Anupama

Subjects
ELECTRONIC health records, CHIMERIC antigen receptors, NON-Hodgkin's lymphoma, OVERALL survival, DISEASE relapse
Abstract

This study used COTA de-identified data (2010–2021) of patients in the US to explore outcomes of novel therapies in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) in real-world settings. Demographics, clinical characteristics, and clinical outcomes of patients with R/R DLBCL who received novel treatments including chimeric antigen receptor T-cell (CAR T) therapy and tafasitamab- or polatuzumab-based therapies were evaluated. Overall, 175 patients with R/R DLBCL were analyzed; 73, 69, and 27 received CAR T therapy, polatuzumab-based regimens, and tafasitamab-based regimens, respectively. In patients who had ≥1 prior lines of therapy (i.e. starting second-line or later therapy; 2 L+), CAR T, polatuzumab-based regimens, and tafasitamab-based regimens achieved a median overall survival of 26.5, 7.8, and 6.3 months, respectively. Outcomes were particularly poor for patients with relapse following CAR T, indicating that polatuzumab- and tafasitamab-based regimens in 2 L + R/R DLBCL have suboptimal outcomes in the real world. Additional treatment options are needed. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA

Author

Cavo, Michele, San-Miguel, Jesus, Usmani, Saad Z., Weisel, Katja, Dimopoulos, Meletios A., Avet-Loiseau, Hervé, Paiva, Bruno, Bahlis, Nizar J., Plesner, Torben, Hungria, Vania, Moreau, Philippe, Mateos, Maria-Victoria, Perrot, Aurore, Iida, Shinsuke, Facon, Thierry, Kumar, Shaji, van de Donk, Niels W.C.J., Sonneveld, Pieter, Spencer, Andrew, Krevvata, Maria, Heuck, Christoph, Wang, Jianping, Ukropec, Jon, Kobos, Rachel, Sun, Steven, Qi, Mia, and Munshi, Nikhil

Published
2022
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4. Sustained minimal residual disease negativity in newly diagnosed multiple myeloma and the impact of daratumumab in MAIA and ALCYONE

Author

San-Miguel, Jesus, Avet-Loiseau, Hervé, Paiva, Bruno, Kumar, Shaji, Dimopoulos, Meletios A., Facon, Thierry, Mateos, María-Victoria, Touzeau, Cyrille, Jakubowiak, Andrzej, Usmani, Saad Z., Cook, Gordon, Cavo, Michele, Quach, Hang, Ukropec, Jon, Ramaswami, Priya, Pei, Huiling, Qi, Mia, Sun, Steven, Wang, Jianping, Krevvata, Maria, DeAngelis, Nikki, Heuck, Christoph, Van Rampelbergh, Rian, Kudva, Anupa, Kobos, Rachel, Qi, Ming, and Bahlis, Nizar J.

Published
2022
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5. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE

Author

Mateos, Maria-Victoria, Dimopoulos, Meletios A., Cavo, Michele, Suzuki, Kenshi, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Pour, Ludek, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna Marina, Campbell, Philip, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Iida, Shinsuke, Bladé, Joan, Ukropec, Jon, Pei, Huiling, Van Rampelbergh, Rian, Kudva, Anupa, Qi, Ming, and San-Miguel, Jesus

Published
2021
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6. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial

Author

Alegre Amor, Adrian, Baldini, Luca, Beksac, Meral, Belotti, Angelo, Benboubker, Lotfi, Besemer, Britta, Besisik, Sevgi, Bila, Jelena, Boccadoro, Mario, Cavo, Michele, De La Rubia Comos, Javier, Delimpasi, Sosana, Dimopoulos, Meletios A., Doyen, Chantal, Dytfeld, Dominik, Engelhardt, Monika, Facon, Thierry, Foà, Roberto, Goldschmidt, Hartmut, Grosicki, Sebastian, Hajek, Roman, Hayri Ozsan, Guner, Hulin, Cyrille, Iversen, Brian, Karlin, Lionel, Katodritou, Eirini, Knop, Stefan, Kyrtsonis, Marie-Christine, Lahuerta, Juan Jose, Leleu, Xavier, Martinez Chamorro, Carmen, Mateos Manteca, María-Victoria, Meuleman, Nathalie, Minnema, Monique, Moreau, Philippe, Offidani, Massino, Oriol Rocafiguera, Albert, Pehlivan, Mustafa, Pour, Ludek, Roerdink, Henk Th.J., Rosinol Dacsh, Laura, Salwender, Hans, Sonneveld, Pieter, Symeonidis, Anargyros, Toftmann Hansen, Charlotte, Tuglular, Tulin, Unal, Ali, Vlummens, Philip, Vural, Filiz, Wu, Ka Lung, Zweegman, Sonja, Dimopoulos, Meletios A, Terpos, Evangelos, Symeonidis, Argiris, Oriol, Albert, Mateos, Maria-Victoria, Einsele, Hermann, Orfanidis, Ioannis, Ahmadi, Tahamtan, Ukropec, Jon, Kampfenkel, Tobias, Schecter, Jordan M, Qiu, Yanping, Amin, Himal, Vermeulen, Jessica, and Carson, Robin

Published
2021
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10. Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial

Author

Voorhees, Peter M., Kaufman, Jonathan L., Laubach, Jacob, Sborov, Douglas W., Reeves, Brandi, Rodriguez, Cesar, Chari, Ajai, Silbermann, Rebecca, Costa, Luciano J., Anderson, Larry D., Jr, Nathwani, Nitya, Shah, Nina, Efebera, Yvonne A., Holstein, Sarah A., Costello, Caitlin, Jakubowiak, Andrzej, Wildes, Tanya M., Orlowski, Robert Z., Shain, Kenneth H., Cowan, Andrew J., Murphy, Sean, Lutska, Yana, Pei, Huiling, Ukropec, Jon, Vermeulen, Jessica, de Boer, Carla, Hoehn, Daniela, Lin, Thomas S., and Richardson, Paul G.

Published
2020
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11. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR

Author

Mateos, Maria-Victoria, Sonneveld, Pieter, Hungria, Vania, Nooka, Ajay K., Estell, Jane A., Barreto, Wolney, Corradini, Paolo, Min, Chang-Ki, Medvedova, Eva, Weisel, Katja, Chiu, Christopher, Schecter, Jordan M., Amin, Himal, Qin, Xiang, Ukropec, Jon, Kobos, Rachel, and Spencer, Andrew

Published
2020
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12. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial

Author

Mateos, Maria-Victoria, Cavo, Michele, Blade, Joan, Dimopoulos, Meletios A, Suzuki, Kenshi, Jakubowiak, Andrzej, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna Marina, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Krevvata, Maria, Chen, Ying, Wang, Jianping, Kudva, Anupa, Ukropec, Jon, Wroblewski, Susan, Qi, Ming, Kobos, Rachel, and San-Miguel, Jesus

Published
2020
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13. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study

Author

Bahlis, Nizar J., Dimopoulos, Meletios A., White, Darrell J., Benboubker, Lotfi, Cook, Gordon, Leiba, Merav, Ho, P. Joy, Kim, Kihyun, Takezako, Naoki, Moreau, Philippe, Kaufman, Jonathan L., Krevvata, Maria, Chiu, Christopher, Qin, Xiang, Okonkwo, Linda, Trivedi, Sonali, Ukropec, Jon, Qi, Ming, and San-Miguel, Jesus

Published
2020
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18. International Myeloma Working Group risk stratification model for smoldering multiple myeloma (SMM)

Author

Mateos, María-Victoria, Kumar, Shaji, Dimopoulos, Meletios A., González-Calle, Verónica, Kastritis, Efstathios, Hajek, Roman, De Larrea, Carlos Fernández, Morgan, Gareth J., Merlini, Giampaolo, Goldschmidt, Hartmut, Geraldes, Catarina, Gozzetti, Alessandro, Kyriakou, Charalampia, Garderet, Laurent, Hansson, Markus, Zamagni, Elena, Fantl, Dorotea, Leleu, Xavier, Kim, Byung-Su, Esteves, Graça, Ludwig, Heinz, Usmani, Saad, Min, Chang-Ki, Qi, Ming, Ukropec, Jon, Weiss, Brendan M., Rajkumar, S. Vincent, Durie, Brian G. M., and San-Miguel, Jesús

Published
2020
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19. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk

Author

Weisel, Katja, Spencer, Andrew, Lentzsch, Suzanne, Avet-Loiseau, Hervé, Mark, Tomer M., Spicka, Ivan, Masszi, Tamas, Lauri, Birgitta, Levin, Mark-David, Bosi, Alberto, Hungria, Vania, Cavo, Michele, Lee, Je-Jung, Nooka, Ajay, Quach, Hang, Munder, Markus, Lee, Cindy, Barreto, Wolney, Corradini, Paolo, Min, Chang-Ki, Chanan-Khan, Asher A., Horvath, Noemi, Capra, Marcelo, Beksac, Meral, Ovilla, Roberto, Jo, Jae-Cheol, Shin, Ho-Jin, Sonneveld, Pieter, Casneuf, Tineke, DeAngelis, Nikki, Amin, Himal, Ukropec, Jon, Kobos, Rachel, and Mateos, Maria-Victoria

Published
2020
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22. Sustained Minimal Residual Disease (MRD) Negativity and Clinical Efficacy in Transplant-Ineligible (TIE) Newly Diagnosed Multiple Myeloma (NDMM) Patients (Pts) Treated with Daratumumab-Based Regimens: Analysis of Maia and Alcyone

Author

San-Miguel, Jesus F., Avet-Loiseau, Herve, Paiva, Bruno, Kumar, Shaji K., Dimopoulos, Meletios A., Facon, Thierry, Mateos, Maria-Victoria, Touzeau, Cyrille, Jakubowiak, Andrzej, Usmani, Saad Z., Cook, Gordon, Cavo, Michele, Quach, Hang, Ukropec, Jon, Ramaswami, Priya, Pei, Huiling, Sun, Steven, Wang, Jianping, Krevvata, Maria, DeAngelis, Nikki, Heuck, Christoph, Van Rampelbergh, Rian, Kudva, Anupa, Kobos, Rachel, Qi, Ming, and Bahlis, Nizar J.

Published
2020
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23. Updated Analysis of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma (NDMM): The Phase 3 Maia Study

Author

Kumar, Shaji K., Facon, Thierry, Usmani, Saad Z., Plesner, Torben, Orlowski, Robert Z., Touzeau, Cyrille, Basu, Supratik, Bahlis, Nizar J., Goldschmidt, Hartmut, O'Dwyer, Michael E., Venner, Christopher P., Weisel, Katja, Hulin, Cyrille, Karlin, Lionel, Preis, Meir, Broyl, Annemiek, Renwick, William, Hansson, Markus, Krevvata, Maria, Wang, Jianping, Van Rampelbergh, Rian, Ukropec, Jon, Uhlar, Clarissa M., Kobos, Rachel, and Perrot, Aurore

Published
2020
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24. Effect of Lenalidomide (R) +/- Dexamethasone (d) Discontinuation on Daratumumab Efficacy in Multiple Myeloma (MM): Subgroup Analysis of the Phase 3 MAIA and POLLUX Studies

Author

Moreau, Philippe, Facon, Thierry, Saad Usmani, Dimopoulos, Meletios, Kumar, Shaji, Plesner, Torben, Goldschmidt, Hartmut, Reece, Donna, Orlowski, Robert Z., Perrot, Aurore, Leiba, Merav, Chari, Ajai, San-Miguel, Jesus, Cook, Gordon, Iida, Shinsuke, Pei, Huiling, Rampelbergh, Rian, Uhlar, Clarissa M., Renaud, Thomas, Ukropec, Jon, Kobos, Rachel, and Bahlis, Nizar

Subjects
multiple myeloma, newly diagnosed multiple myeloma, MM, daratumumab, lenalidomide discontinuation
Published
2020
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25. Daratumumab-based regimens are highly effective and well tolerated in relapsed or refractory multiple myeloma regardless of patient age: subgroup analysis of the phase 3 CASTOR and POLLUX studies

Author

Mateos, Maria-Victoria Spencer, Andrew Nooka, Ajay K. Pour, Ludek Weisel, Katja Cavo, Michele Laubach, Jacob P. and Cook, Gordon Iida, Shinsuke Benboubker, Lotfi Usmani, Saad Z. Yoon, Sung-Soo Bahlis, Nizar J. Chiu, Christopher and Ukropec, Jon Schecter, Jordan M. Qin, Xiang O'Rourke, Lisa and Dimopoulos, Meletios A.

Subjects
Health Sciences, Επιστήμες Υγείας
Abstract

The phase 3 POLLUX and CASTOR studies demonstrated superior benefit of daratumumab plus lenalidomide/dexamethasone or bortezomib/dexamethasone in relapsed/refractory multiple myeloma. Efficacy and safety of daratumumab was analyzed according to age groups of 65 to 74 years and >= 75 years. Patients received >= 1 prior line of therapy. In POLLUX, patients received lenalidomide/dexamethasone +/- daratumumab (16 mg/kg weekly, cycles 1-2; every two weeks, cycles 3-6; monthly until progression). In CASTOR, patients received eight cycles of bortezomib/dexamethasone +/- daratumumab (16 mg/kg weekly, cycles 1-3; every three weeks, cycles 4-8; monthly until progression). Patients aged >75 years received dexamethasone 20 mg weekly. For patients aged >= 75 years in POLLUX (median follow-up: 25.4 months), daratumumab/lenalidomide/dexamethasone prolonged progression-free survival versus lenalidomide/dexamethasone (median: 28.9 versus 11.4 months; hazard ratio, 0.27; 95% confidence interval, 0.10-0.69; P=0.0042) and increased overall response rate (93.1% versus 76.5%; P=0.0740). Neutropenia was the most common grade 3/4 treatment-emergent adverse event (daratumumab: 44.8%; control: 31.4%). Infusion-related reactions occurred in 12 (41.4%) patients. For patients aged >= 75 years in CASTOR (median follow-up: 19.4 months), daratumumab/bortezomib/dexamethasone prolonged progression-free survival versus bortezomib/dexamethasone (median: 17.9 versus 8.1 months; hazard ratio, 0.26; 95% confidence interval, 0.10-0.65; P=0.0022) and increased overall response rate (95.0% versus 78.8%; P=0.1134). Thrombocytopenia was the most common grade 3/4 treatment-emergent adverse event (daratumumab: 45.0%; control: 37.1%). Infusion-related reactions occurred in 13 (65.0%) patients. Similar findings were reported for patients aged 65 to 74 years in both studies. Taken together, this subgroup analysis of efficacy and safety of daratumumab was largely consistent with the overall populations.

Published
2020

27. Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma

Author

Chari, Ajai, Lonial, Sagar, Mark, Tomer M., Krishnan, Amrita Y., Stockerl‐Goldstein, Keith E., Usmani, Saad Z., Londhe, Anil, Etheredge, Delores, Fleming, Sarah, Liu, Baolian, Ukropec, Jon, Lin, Thomas S., Jagannath, Sundar, and Nooka, Ajay K.

Subjects
Adult, Cyclopropanes, Male, Acetates, Sulfides, Drug Administration Schedule, Discipline, Antineoplastic Agents, Immunological, Humans, Clinical Trials, Infusions, Intravenous, Drug Approval, Aged, Aged, 80 and over, Antibodies, Monoclonal, Original Articles, Middle Aged, daratumumab, Survival Analysis, United States, Injection Site Reaction, multiple myeloma, Treatment Outcome, montelukast, Quinolines, Original Article, Female, monoclonal antibodies, Neoplasm Recurrence, Local, CD38
Abstract

Background Daratumumab is a human CD38‐directed monoclonal antibody indicated for the treatment of relapsed and refractory multiple myeloma (MM). Methods A multicenter, open‐label treatment protocol provided early access to daratumumab for patients who had progressive MM after they received ≥3 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent or if they were refractory to both a proteasome inhibitor and an immunomodulatory agent. Patients received daratumumab 16 mg/kg weekly for 8 weeks, every other week for 16 weeks, and monthly until they developed disease progression, unacceptable toxicity, or 60 days after the drug gained US approval. Treatment‐emergent grade ≥3 adverse events (AEs), serious AEs, and AEs of special interest were collected. Results Three hundred forty‐eight patients were enrolled at 39 US sites between June and December 2015. Patients received study therapy for a median of 1.9 months (range, 0.03‐6.0 months). Fifty‐two percent of patients transitioned to commercially‐available daratumumab and 37% discontinued because of progressive disease. Grade ≥3 AEs occurred in 50% of patients, including thrombocytopenia (15%) and anemia (14%). Serious AEs occurred in 35% of patients (12% were drug‐related), including infections (11%). Infusion reactions occurred in 56%, 2%, and 2% of patients during the first, second, and all subsequent infusions, respectively; respiratory symptoms (cough, dyspnea, throat irritation, nasal congestion) were common. The infusion reaction rate for the first infusion was 38% in 50 patients at 2 sites who received montelukast as premedication for their first infusion and 59% in patients who did not receive montelukast. Conclusions The current findings are consistent with previously reported trials and confirm the safety profile of daratumumab in heavily pretreated US patients who have relapsed or refractory MM. Cancer 2018;124:000‐000., An early access treatment protocol confirms the safety profile of daratumumab in patients with relapsed or refractory myeloma. Findings from 2 study sites (60 patients) that used montelukast premedication indicate reduced infusion reactions and infusion time associated with the first dose of daratumumab.

Published
2018

28. Four-Year Follow-up of the Phase 3 Pollux Study of Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) Alone in Relapsed or Refractory Multiple Myeloma (RRMM)

Author

Kaufman, Jonathan L. Usmani, Saad Z. San-Miguel, Jesus and Bahlis, Nizar White, Darrell J. Benboubker, Lotfi Cook, Gordon Leiba, Merav Ho, P. Joy Kim, Kihyun Takezako, Naoki Moreau, Philippe Krevvata, Maria Pei, Huiling and Ukropec, Jon Renaud, Thomas Trivedi, Sonali Kobos, Rachel and Dimopoulos, Meletios A.

Published
2019

30. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in Alcyone

Author

Mateos, Maria-Victoria Cavo, Michele Blade, Joan Dimopoulos, Meletios A. Suzuki, Kenshi Jakubowiak, Andrzej Knop, Stefan and Doyen, Chantal Lucio, Paulo Nagy, Zsolt Pour, Ludek and Cook, Mark Grosicki, Sebastian Crepaldi, Andre H. Liberati, Anna Marina Campbell, Philip Shelekhova, Tatiana Yoon, Sung-Soo Iosava, Genadi Fujisaki, Tomoaki Garg, Mamta and Krevvata, Maria Wang, Jianping Kudva, Anupa Ukropec, Jon and Wroblewski, Susan Kobos, Rachel San-Miguel, Jesus

Published
2019

33. Evaluation of Sustained Minimal Residual Disease Negativity With Daratumumab-Combination Regimens in Relapsed and/or Refractory Multiple Myeloma: Analysis of POLLUX and CASTOR.

Author

Avet-Loiseau, Hervé, San-Miguel, Jesus, Casneuf, Tineke, Iida, Shinsuke, Lonial, Sagar, Usmani, Saad Z, Spencer, Andrew, Moreau, Philippe, Plesner, Torben, Weisel, Katja, Ukropec, Jon, Chiu, Christopher, Trivedi, Sonali, Amin, Himal, Krevvata, Maria, Ramaswami, Priya, Qin, Xiang, Qi, Mia, Sun, Steven, and Qi, Ming

Published
2021
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35. Early M‐Protein Dynamics Predicts Progression‐Free Survival in Patients With Relapsed/Refractory Multiple Myeloma.

Author

Yan, Xiaoyu, Xu, Xu Steven, Weisel, Katja C., Mateos, Maria‐Victoria, Sonneveld, Pieter, Dimopoulos, Meletios A., Usmani, Saad Zafar, Bahlis, Nizar J., Puchalski, Thomas, Ukropec, Jon, Bellew, Kevin, Ming, Qi, Sun, Steven, and Zhou, Honghui

Subjects
PROGRESSION-free survival, MULTIPLE myeloma, RECEIVER operating characteristic curves, FORECASTING, TREATMENT effectiveness, MULTIVARIABLE testing, PROPORTIONAL hazards models
Abstract

This study aimed to predict long‐term progression‐free survival (PFS) using early M‐protein dynamic measurements in patients with relapsed/refractory multiple myeloma (MM). The PFS was modeled based on dynamic M‐protein data from two phase III studies, POLLUX and CASTOR, which included 569 and 498 patients with relapsed/refractory MM, respectively. Both studies compared active controls (lenalidomide and dexamethasone, and bortezomib and dexamethasone, respectively) alone vs. in combination with daratumumab. Three M‐protein dynamic features from the longitudinal M‐protein data were evaluated up to different time cutoffs (1, 2, 3, and 6 months). The abilities of early M‐protein dynamic measurements to predict the PFS were evaluated using Cox proportional hazards survival models. Both univariate and multivariable analyses suggest that maximum reduction of M‐protein (i.e., depth of response) was the most predictive of PFS. Despite the statistical significance, the baseline covariates provided very limited predictive value regarding the treatment effect of daratumumab. However, M‐protein dynamic features obtained within the first 2 months reasonably predicted PFS and the associated treatment effect of daratumumab. Specifically, the areas under the time‐varying receiver operating characteristic curves for the model with the first 2 months of M‐protein dynamic data were ~ 0.8 and 0.85 for POLLUX and CASTOR, respectively. Early M‐protein data within the first 2 months can provide a prospective and reasonable prediction of future long‐term clinical benefit for patients with MM. [ABSTRACT FROM AUTHOR]

Published
2020
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37. Long-Term Outcomes and Health-Related Quality of Life (HRQoL) By Response Status for Bortezomib, Melphalan, and Prednisone (VMP) ± Daratumumab (DARA) in Alcyone

Author

Rodriguez-Otero, Paula, Boccadoro, Mario, Hajek, Roman, Fujisaki, Tomoaki, Lee, Jae Hoon, Martinez-Lopez, Joaquin, Lucio, Paulo, Nagy, Zsolt, Usenko, Ganna, Liberati, Anna Marina, Lazaroiu, Mihaela, Woszczyk, Dariusz, Takamatsu, Hiroyuki, Romejko-Jarosinska, Joanna, Knop, Stefan Tobias, Pavlovsky, Astrid, Forsyth, Cecily, Ishikawa, Takayuki, Gries, Katharine S., Pei, Huiling, Kudva, Anupa, Ukropec, Jon, Wroblewski, Susan, Carson, Robin, and Dimopoulos, Meletios A

Published
2020
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39. Daratumumab (DARA) Plus Lenalidomide, Bortezomib, and Dexamethasone (RVd) in Patients with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Updated Analysis of Griffin after 12 Months of Maintenance Therapy

Author

Kaufman, Jonathan L., Laubach, Jacob P., Sborov, Douglas, Reeves, Brandi, Rodriguez, Cesar, Chari, Ajai, Silbermann, Rebecca W., Costa, Luciano J., Anderson, Larry D., Jr., Nathwani, Nitya, Shah, Nina, Efebera, Yvonne A., Holstein, Sara A., Costello, Caitlin, Jakubowiak, Andrzej, Wildes, Tanya M., Orlowski, Robert Z., Shain, Kenneth H., Cowan, Andrew J., Lutska, Yana, Bobba, Padma, Pei, Huiling, Ukropec, Jon, Vermeulen, Jessica, Lin, Thomas S., Richardson, Paul G., and Voorhees, Peter M.

Published
2020
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40. Apollo: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Dimopoulos, Meletios A., Terpos, Evangelos, Boccadoro, Mario, Delimpasi, Sosana, Beksac, Meral, Katodritou, Eirini, Moreau, Philippe, Baldini, Luca, Symeonidis, Argiris, Bila, Jelena, Oriol, Albert, Mateos, Maria-Victoria, Einsele, Hermann, Orfanidis, Ioannis, Ahmadi, Tahamtan, Ukropec, Jon, Kampfenkel, Tobias, Schecter, Jordan, Qiu, Yanping, Amin, Himal, Vermeulen, Jessica, Carson, Robin, and Sonneveld, Pieter

Published
2020
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41. MM-339: Effect of Lenalidomide (R) ± Dexamethasone (d) Discontinuation on Daratumumab Efficacy in Multiple Myeloma (MM): Subgroup Analysis of the Phase 3 MAIA and POLLUX Studies

Author

Moreau, Philippe, Facon, Thierry, Usmani, Saad Z., Dimopoulos, Meletios, Kumar, Shaji, Plesner, Torben, Goldschmidt, Hartmut, Reece, Donna, Orlowski, Robert Z., Perrot, Aurore, Leiba, Merav, Chari, Ajai, San-Miguel, Jesus, Cook, Gordon, Iida, Shinsuke, Pei, Huiling, Rampelbergh, Rian Van, Uhlar, Clarissa M., Renaud, Thomas, Ukropec, Jon, Kobos, Rachel, and Bahlis, Nizar

Published
2020
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42. MM-350: Daratumumab (DARA) + Lenalidomide/Bortezomib/Dexamethasone (RVd) in African American/Black Patients (Pts) with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Subgroup Analysis of GRIFFIN

Author

Nooka, Ajay K., Kaufman, Jonathan L., Rodriguez, Cesar, Jakubowiak, Andrzej, Shune, Leyla, Badros, Ashraf, Chari, Ajai, Richardson, Paul G., Pei, Huiling, Ukropec, Jon, Vermeulen, Jessica, Hoehn, Daniela, Lin, Thomas S., and Voorhees, Peter M.

Published
2020
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43. Daratumumab, bortezomib, cyclophosphamide and dexamethasone in newly diagnosed and relapsed multiple myeloma: LYRA study.

Author

Yimer, Habte, Ukropec, Jon, Qi, Ming, Rifkin, Robert M., Melear, Jason, Faber, Edward, Bensinger, William I., Burke, John M., Narang, Mohit, Stevens, Don, Gunawardena, Sriya, Lutska, Yana, Lin, Thomas S., and Qi, Keqin

Subjects
*MULTIPLE myeloma, *BORTEZOMIB, *STEM cell transplantation, *DEXAMETHASONE, *PROGRESSION-free survival
Abstract

Summary: This United States community study evaluated the combination of daratumumab, bortezomib, cyclophosphamide and dexamethasone (D‐VCd) in newly diagnosed multiple myeloma (NDMM) and relapsed multiple myeloma (RMM). Patients received 4–8 induction cycles of bortezomib 1·5 mg/m2, cyclophosphamide 300 mg/m2 and dexamethasone 40 mg weekly. Intravenous daratumumab 16 mg/kg was administered as approved except for a split‐first dose in Cycle 1. Eligible patients underwent autologous stem cell transplantation. All patients received ≤12 daratumumab maintenance doses monthly. Eighty‐six NDMM and 14 RMM patients received ≥1 treatment dose. In NDMM patients, very good partial response or better (≥VGPR) and overall response rates after 4 induction cycles were 44% (primary endpoint) and 79%, respectively, and 56% and 81% at end of induction. The 12‐month progression‐free survival (PFS) rate was 87%. Efficacy was also observed in RMM patients. Fatigue (59%) and neutropenia (13%) were the most frequent treatment‐emergent adverse event (TEAE) and grade 3/4 TEAE, respectively. Infusion reactions occurred in 54% of patients, primarily during the first dose, and were mild (2% grade 3). The first 2 daratumumab infusions were 4·5 and 3·8 h (median). Overall, D‐VCd was well tolerated, split‐first daratumumab dosing was feasible, the ≥VGPR rate after 4 cycles was 44% and the 1‐year PFS rate was 87%. [ABSTRACT FROM AUTHOR]

Published
2019
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45. Daratumumab (DARA) Maintenance Therapy Improves Depth of Response and Results in Durable Progression-Free Survival (PFS) Following Dara Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) Induction Therapy in Multiple Myeloma (MM): Update of the Lyra Study

Author

Rifkin, Robert M., Melear, Jason M., Faber, Edward, Bensinger, William I., Burke, John M, Narang, Mohit, Stevens, Don, Gunawardena, Sriya, Lutska, Yana, Qi, Keqin, Ukropec, Jon, Qi, Ming, Lin, Thomas S., and Yimer, Habte A

Published
2019
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46. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in Alcyone

Author

Mateos, Maria-Victoria, Cavo, Michele, Bladé, Joan, Dimopoulos, Meletios A., Suzuki, Kenshi, Jakubowiak, Andrzej, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre H, Liberati, Anna Marina, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Krevvata, Maria, Wang, Jianping, Kudva, Anupa, Ukropec, Jon, Wroblewski, Susan, Kobos, Rachel, and San-Miguel, Jesús

Published
2019
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47. Depth of Response to Daratumumab (DARA), Lenalidomide, Bortezomib, and Dexamethasone (RVd) Improves over Time in Patients (pts) with Transplant-Eligible Newly Diagnosed Multiple Myeloma (NDMM): Griffin Study Update

Author

Voorhees, Peter M., Kaufman, Jonathan L., Laubach, Jacob P., Sborov, Douglas W., Reeves, Brandi, Rodriguez, Cesar, Chari, Ajai, Silbermann, Rebecca W., Costa, Luciano J., Anderson, Larry D., Nathwani, Nitya, Shah, Nina D., Efebera, Yvonne A., Costello, Caitlin L., Jakubowiak, Andrzej, Wildes, Tanya M., Orlowski, Robert Z., Shain, Kenneth H., Cowan, Andrew J., Murphy, Sean, Lutska, Yana, Pei, Huiling, Ukropec, Jon, Vermeulen, Jessica, de Boer, Carla, Hoehn, Daniela, Lin, Thomas S., and Richardson, Paul G.

Published
2019
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48. 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., Sonneveld, Pieter, Mateos, Maria-Victoria, Hungria, Vania T.M., Spencer, Andrew, Estell, Jane, Barreto, Wolney G, Corradini, Paolo, Min, Chang-Ki, Medvedova, Eva, Krevvata, Maria, Trivedi, Sonali, Qin, Xiang, Pei, Huiling, Ukropec, Jon, Kobos, Rachel, Qi, Ming, and Nooka, Ajay K

Published
2019
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50. Daratumumab Plus Lenalidomide and Dexamethasone (D-Rd) Versus Lenalidomide and Dexamethasone (Rd) in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Ineligible for Transplant: Updated Analysis of Maia

Author

Bahlis, Nizar, Facon, Thierry, Usmani, Saad Z., Kumar, Shaji K., Plesner, Torben, Orlowski, Robert Z., Touzeau, Cyrille, Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O'Dwyer, Michael E, Venner, Christopher P, Weisel, Katja C., Krevvata, Maria, Pei, Huiling, Wang, Jianping, Van Rampelbergh, Rian, Ukropec, Jon, Uhlar, Clarissa M., Kobos, Rachel, and Perrot, Aurore

Published
2019
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