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1. 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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2. 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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3. 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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4. Population pharmacokinetics and exposure–response analyses of daratumumab plus pomalidomide/dexamethasone in relapsed or refractory multiple myeloma

Author

Dosne, Anne Gaelle, Li, Xia, Luo, Man Melody, Nnane, Ivo, Dimopoulos, Meletios A., Terpos, Evangelos, Sonneveld, Pieter, Kampfenkel, Tobias, Carson, Robin, Amin, Himal, Perez Ruixo, Juan, Zhou, Honghui, Sun, Yu Nien, Xu, Yan, Dosne, Anne Gaelle, Li, Xia, Luo, Man Melody, Nnane, Ivo, Dimopoulos, Meletios A., Terpos, Evangelos, Sonneveld, Pieter, Kampfenkel, Tobias, Carson, Robin, Amin, Himal, Perez Ruixo, Juan, Zhou, Honghui, Sun, Yu Nien, and Xu, Yan

Abstract

Aim: A population pharmacokinetic (PPK) model was developed to characterize pharmacokinetics (PK) of subcutaneous or intravenous daratumumab administration in a new indication (i.e., combination with pomalidomide and dexamethasone [D-Pd] in patients with relapsed or refractory multiple myeloma [RRMM]). Analyses were conducted to explore exposure–response (E-R) relationships for efficacy and select treatment-emergent adverse events (TEAEs). Methods: The PPK analysis included pooled data from the D-Pd cohorts of the phase 3 APOLLO and phase 1b EQUULEUS studies. Covariates were evaluated in the PPK model. Model-predicted exposures to daratumumab were compared between covariate subgroups of interest and used to investigate relationships between daratumumab exposure and efficacy and safety in APOLLO. Results: The PPK analysis included 1146 daratumumab PK samples from 239 patients (APOLLO, n = 140; EQUULEUS, n = 99). Observed concentration–time data of daratumumab were well described by a two-compartment PPK model with first-order absorption and parallel linear and nonlinear elimination pathways. Treatment with D-Pd provided similar daratumumab PK characteristics versus historical daratumumab monotherapy. The E-R dataset contained data from 290 APOLLO patients (D-Pd, n = 140; Pd, n = 150). The PK–efficacy relationship of daratumumab supported improved progression-free survival for patients in the D-Pd group vs. the Pd group. Additionally, TEAEs did not increase with increasing PK exposure in the D-Pd group. Conclusions: The PPK and E-R analyses support the daratumumab subcutaneous 1800 mg dosing regimen in combination with Pd for treatment of patients with RRMM. No dose adjustment is recommended in this indication for any of the investigated factors, none of which had clinically relevant effects on daratumumab PK.

Published
2023

5. Population pharmacokinetics and exposure–response analyses of daratumumab plus pomalidomide/dexamethasone in relapsed or refractory multiple myeloma

Author

Dosne, Anne‐Gaelle, primary, Li, Xia, additional, Luo, Man Melody, additional, Nnane, Ivo, additional, Dimopoulos, Meletios A., additional, Terpos, Evangelos, additional, Sonneveld, Pieter, additional, Kampfenkel, Tobias, additional, Carson, Robin, additional, Amin, Himal, additional, Perez Ruixo, Juan, additional, Zhou, Honghui, additional, Sun, Yu‐Nien, additional, and Xu, Yan, additional

Published
2022
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6. MajesTEC-4 (EMN30): A Phase 3 Trial of Teclistamab + Lenalidomide Versus Lenalidomide Alone As Maintenance Therapy Following Autologous Stem Cell Transplantation in Patients with Newly Diagnosed Multiple Myeloma

Author

Zamagni, Elena, primary, Boccadoro, Mario, additional, Spencer, Andrew, additional, Delforge, Michel, additional, Reece, Donna E., additional, Gyula Szabo, Agoston, additional, Einsele, Hermann, additional, Terpos, Evangelos, additional, Schjesvold, Fredrik, additional, Bila, Jelena, additional, Driessen, Christoph, additional, Beksac, Meral, additional, Cook, Gordon, additional, Rodriguez, Cesar, additional, Pei, Lixia, additional, Shi, Yingqi, additional, Sakabedoyan, Caline, additional, Jasielec, Jagaoda, additional, Amin, Himal, additional, Kobos, Rachel, additional, Sonneveld, Pieter, additional, and Van De Donk, Niels WCJ, additional

Published
2022
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7. Health-related quality of life in patients with relapsed/refractory multiple myeloma treated with pomalidomide and dexamethasone ± subcutaneous daratumumab: Patient-reported outcomes from the APOLLO trial

Author

Janssen Research and Development, Terpos, Evangelos, Dimopoulos, Meletios A., Boccadoro, Mario, Delimpasi, Sosana, Beksac, Meral, Katodritou, Eirini, Moreau, Philippe, Pompa, Alessandra, Symeonidis, Argiris, Bila, Jelena, Oriol, Albert, Mateos, Maria Victoria, Einsele, Hermann, Orfanidis, Ioannis, Gries, Katharine S., Fastenau, John, Liu, Kevin, He, Jianming, Kampfenkel, Tobias, Qiu, Yanping, Amin, Himal, Carson, Robin, Sonneveld, Pieter, Janssen Research and Development, Terpos, Evangelos, Dimopoulos, Meletios A., Boccadoro, Mario, Delimpasi, Sosana, Beksac, Meral, Katodritou, Eirini, Moreau, Philippe, Pompa, Alessandra, Symeonidis, Argiris, Bila, Jelena, Oriol, Albert, Mateos, Maria Victoria, Einsele, Hermann, Orfanidis, Ioannis, Gries, Katharine S., Fastenau, John, Liu, Kevin, He, Jianming, Kampfenkel, Tobias, Qiu, Yanping, Amin, Himal, Carson, Robin, and Sonneveld, Pieter

Abstract

In the phase 3 APOLLO trial, daratumumab in combination with pomalidomide and dexamethasone (D-Pd) significantly reduced the rate of disease progression or death by 37% relative to Pd alone in patients with relapsed/refractory multiple myeloma (RRMM) who had received ≥1 prior line of therapy including lenalidomide and a proteasome inhibitor. Here, we present patient-reported outcomes (PROs) from APOLLO. Median treatment duration was 11.5 months with D-Pd and 6.6 months with Pd. PRO compliance rates were high and similar in both groups. No changes from baseline were observed for EORTC QLQ-C30 global health status scores in either group, while physical and emotional functioning, disease symptoms, and adverse effects of treatment remained at baseline levels with D-Pd but worsened with Pd. Reductions (p < 0.05) in pain and fatigue were seen at several time points with D-Pd versus Pd. Overall, these results suggest patients' health-related quality of life remained stable when daratumumab was added to Pd, with several results favoring D-Pd versus Pd. These findings complement the significant clinical improvements observed with D-Pd and support its use in patients with RRMM.

Published
2022

8. Supplementary files of the article Health-related quality of life in patients with relapsed/refractory multiple myeloma treated with pomalidomide and dexamethasone ± subcutaneous daratumumab: Patient-reported outcomes from the APOLLO trial [Dataset]

Author

Terpos, Evangelos, Dimopoulos, Meletios A., Boccadoro, Mario, Delimpasi, Sosana, Beksac, Meral, Katodritou, Eirini, Moreau, Philippe, Pompa, Alessandra, Symeonidis, Argiris, Bila, Jelena, Oriol, Albert, Mateos, Maria Victoria, Einsele, Hermann, Orfanidis, Ioannis, Gries, Katharine S., Fastenau, John, Liu, Kevin, He, Jianming, Kampfenkel, Tobias, Qiu, Yanping, Amin, Himal, Carson, Robin, Sonneveld, Pieter, Terpos, Evangelos, Dimopoulos, Meletios A., Boccadoro, Mario, Delimpasi, Sosana, Beksac, Meral, Katodritou, Eirini, Moreau, Philippe, Pompa, Alessandra, Symeonidis, Argiris, Bila, Jelena, Oriol, Albert, Mateos, Maria Victoria, Einsele, Hermann, Orfanidis, Ioannis, Gries, Katharine S., Fastenau, John, Liu, Kevin, He, Jianming, Kampfenkel, Tobias, Qiu, Yanping, Amin, Himal, Carson, Robin, and Sonneveld, Pieter

Published
2022

9. Population pharmacokinetics and exposure–response analyses of daratumumab plus pomalidomide/dexamethasone in relapsed or refractory multiple myeloma.

Author

Dosne, Anne‐Gaelle, Li, Xia, Luo, Man Melody, Nnane, Ivo, Dimopoulos, Meletios A., Terpos, Evangelos, Sonneveld, Pieter, Kampfenkel, Tobias, Carson, Robin, Amin, Himal, Perez Ruixo, Juan, Zhou, Honghui, Sun, Yu‐Nien, and Xu, Yan

Subjects
DARATUMUMAB, PHARMACOKINETICS, MULTIPLE myeloma, OVERALL survival, DEXAMETHASONE, INTRAVENOUS therapy
Abstract

Aim: A population pharmacokinetic (PPK) model was developed to characterize pharmacokinetics (PK) of subcutaneous or intravenous daratumumab administration in a new indication (i.e., combination with pomalidomide and dexamethasone [D‐Pd] in patients with relapsed or refractory multiple myeloma [RRMM]). Analyses were conducted to explore exposure–response (E‐R) relationships for efficacy and select treatment‐emergent adverse events (TEAEs). Methods: The PPK analysis included pooled data from the D‐Pd cohorts of the phase 3 APOLLO and phase 1b EQUULEUS studies. Covariates were evaluated in the PPK model. Model‐predicted exposures to daratumumab were compared between covariate subgroups of interest and used to investigate relationships between daratumumab exposure and efficacy and safety in APOLLO. Results: The PPK analysis included 1146 daratumumab PK samples from 239 patients (APOLLO, n = 140; EQUULEUS, n = 99). Observed concentration–time data of daratumumab were well described by a two‐compartment PPK model with first‐order absorption and parallel linear and nonlinear elimination pathways. Treatment with D‐Pd provided similar daratumumab PK characteristics versus historical daratumumab monotherapy. The E‐R dataset contained data from 290 APOLLO patients (D‐Pd, n = 140; Pd, n = 150). The PK–efficacy relationship of daratumumab supported improved progression‐free survival for patients in the D‐Pd group vs. the Pd group. Additionally, TEAEs did not increase with increasing PK exposure in the D‐Pd group. Conclusions: The PPK and E‐R analyses support the daratumumab subcutaneous 1800 mg dosing regimen in combination with Pd for treatment of patients with RRMM. No dose adjustment is recommended in this indication for any of the investigated factors, none of which had clinically relevant effects on daratumumab PK. [ABSTRACT FROM AUTHOR]

Published
2023
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10. Health‐related quality of life in patients with relapsed/refractory multiple myeloma treated with pomalidomide and dexamethasone ± subcutaneous daratumumab: Patient‐reported outcomes from the APOLLO trial

Author

Terpos, Evangelos, primary, Dimopoulos, Meletios A., additional, Boccadoro, Mario, additional, Delimpasi, Sosana, additional, Beksac, Meral, additional, Katodritou, Eirini, additional, Moreau, Philippe, additional, Pompa, Alessandra, additional, Symeonidis, Argiris, additional, Bila, Jelena, additional, Oriol, Albert, additional, Mateos, Maria‐Victoria, additional, Einsele, Hermann, additional, Orfanidis, Ioannis, additional, Gries, Katharine S., additional, Fastenau, John, additional, Liu, Kevin, additional, He, Jianming, additional, Kampfenkel, Tobias, additional, Qiu, Yanping, additional, Amin, Himal, additional, Carson, Robin, additional, and Sonneveld, Pieter, additional

Published
2022
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11. Pomalidomide and Dexamethasone with or without Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Updated Analysis of the Phase 3 Apollo Study

Author

Sonneveld, Pieter, primary, Terpos, Evangelos, additional, Boccadoro, Mario, additional, Delimpasi, Sosana, additional, Beksac, Meral, additional, Katodritou, Eirini, additional, Moreau, Philippe, additional, Baldini, Luca, additional, Symeonidis, Argiris, additional, Bila, Jelena, additional, Oriol, Albert, additional, Mateos, Maria-Victoria, additional, Einsele, Hermann, additional, Orfanidis, Ioannis, additional, Kampfenkel, Tobias, additional, Qiu, Yanping, additional, Amin, Himal, additional, Kosh, Michele, additional, Tran, NamPhuong, additional, Carson, Robin, additional, and Dimopoulos, Meletios A., additional

Published
2021
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12. Health-related quality of life (HRQoL) in patients with relapsed/refractory multiple myeloma (RRMM) treated with pomalidamide and dexamethasone +/- subcutaneous daratumumab: Patient-reported outcomes (PROs) in APOLLO

Author

Terpos, Evangelos Dimopoulos, Meletios A. Boccadoro, Mario and Delimpasi, Sosana Beksac, Meral Katodritou, Eirini Moreau, Philippe Baldini, Luca Symeonidis, Argiris Bila, Jelena and Oriol, Albert Mateos, Maria-Victoria Einsele, Hermann and Orfanidis, Ioannis Gries, Katharine S. Fastenau, John and Kampfenkel, Tobias Qiu, Yanping Amin, Himal Sonneveld, Pieter

Published
2021

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

Author

Multiple Myeloma Research Foundation, Janssen Research and Development, 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 M., Qiu, Yanping, Amin, Himal, Vermeulen, Jessica, Carson, Robin, Sonneveld, Pieter, Multiple Myeloma Research Foundation, Janssen Research and Development, 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 M., Qiu, Yanping, Amin, Himal, Vermeulen, Jessica, Carson, Robin, and Sonneveld, Pieter

Abstract

Background: In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response or better rate of 42% and was well tolerated in patients with heavily pretreated multiple myeloma. We aimed to evaluate whether daratumumab plus pomalidomide and dexamethasone would improve progression-free survival versus pomalidomide and dexamethasone alone in patients with previously treated multiple myeloma. Methods: In this ongoing, open-label, randomised, phase 3 trial (APOLLO) done at 48 academic centres and hospitals across 12 European countries, eligible patients were aged 18 years or older, had relapsed or refractory multiple myeloma with measurable disease, had an Eastern Cooperative Oncology Group performance status of 0–2, had at least one previous line of therapy, including lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of antimyeloma therapy, and were refractory to lenalidomide if only one previous line of therapy was received. Patients were randomly assigned (1:1) by an interactive web-response system in a random block size of two or four to receive pomalidomide and dexamethasone alone or daratumumab plus pomalidomide and dexamethasone. Randomisation was stratified by number of previous lines of therapy and International Staging System disease stage. All patients received oral pomalidomide (4 mg, once daily on days 1–21) and oral dexamethasone (40 mg once daily on days 1, 8, 15, and 22; 20 mg for those aged 75 years or older) at each 28-day cycle. The daratumumab plus pomalidomide and dexamethasone group received daratumumab (1800 mg subcutaneously or 16 mg/kg intravenously) weekly during cycles 1 and 2, every 2 weeks during cycles 3–6, and every 4 weeks thereafter until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival in the intention-to-treat population. Safety was analysed in all patients who received at least one do

Published
2021

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

Author

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

Published
2021
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15. Health-related quality of life (HRQoL) in patients with relapsed/refractory multiple myeloma (RRMM) treated with pomalidamide and dexamethasone ± subcutaneous daratumumab: Patient-reported outcomes (PROs) in APOLLO.

Author

Terpos, Evangelos, primary, Dimopoulos, Meletios A., additional, Boccadoro, Mario, additional, Delimpasi, Sosana, additional, Beksac, Meral, additional, Katodritou, Eirini, additional, Moreau, Philippe, additional, Baldini, Luca, additional, Symeonidis, Argiris, additional, Bila, Jelena, additional, Oriol, Albert, additional, Mateos, Maria-Victoria, additional, Einsele, Hermann, additional, Orfanidis, Ioannis, additional, Gries, Katharine S., additional, Fastenau, John, additional, Kampfenkel, Tobias, additional, Qiu, Yanping, additional, Amin, Himal, additional, and Sonneveld, Pieter, additional

Published
2021
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16. 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, primary, San-Miguel, Jesus, additional, Casneuf, Tineke, additional, Iida, Shinsuke, additional, Lonial, Sagar, additional, Usmani, Saad Z., additional, Spencer, Andrew, additional, Moreau, Philippe, additional, Plesner, Torben, additional, Weisel, Katja, additional, Ukropec, Jon, additional, Chiu, Christopher, additional, Trivedi, Sonali, additional, Amin, Himal, additional, Krevvata, Maria, additional, Ramaswami, Priya, additional, Qin, Xiang, additional, Qi, Mia, additional, Sun, Steven, additional, Qi, Ming, additional, Kobos, Rachel, additional, and Bahlis, Nizar J., additional

Published
2021
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17. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: Subgroup analysis of CASTOR based on cytogenetic risk

Author

Janssen Research and Development, Weisel, Katja C., Spencer, Andrew, Lentzsch, Suzanne, Avet-Loiseau, Hervé, Mark, Tomer M., Špička, 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, Mateos, Maria Victoria, Janssen Research and Development, Weisel, Katja C., Spencer, Andrew, Lentzsch, Suzanne, Avet-Loiseau, Hervé, Mark, Tomer M., Špička, 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

Abstract

Background: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). [Methods]: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. [Results]: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. [Conclusion]: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. Trial registration: ClinicalTrials.gov, NCT02136134. Registered 12 May 2014

Published
2020

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

Published
2020
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19. 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

20. 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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21. Efficacy of Daratumumab in Combination with Standard of Care Regimens in Lenalidomide-Exposed or -Refractory Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Analysis of the Castor, Pollux, and MMY1001 Studies

Author

Usmani, Saad Z., primary, Mateos, Maria-Victoria, additional, Lentzsch, Suzanne, additional, Quach, Hang, additional, Capra, Marcelo, additional, Ovilla, Roberto, additional, Jo, Jae-Cheol, additional, Shin, Ho-Jin, additional, Sonneveld, Pieter, additional, Qi, Ming, additional, Amin, Himal, additional, Wang, Jianping, additional, Qin, Xiang, additional, Okonkwo, Linda, additional, Ukropec, Jon, additional, Trivedi, Sonali, additional, Suzuki, Kenshi, additional, Dimopoulos, Meletios A, additional, Cavo, Michele, additional, Nooka, Ajay K, additional, Chari, Ajai, additional, and Facon, Thierry, additional

Published
2018
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22. 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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23. Daratumumab, bortezomib and dexamethasone (DVd) vs bortezomib and dexamethasone (Vd) in relapsed or refractory multiple myeloma (RRMM): Efficacy and safety update (CASTOR).

Author

Lentzsch, Suzanne, primary, Weisel, Katja C., additional, Mateos, Maria-Victoria, additional, Hungria, Vania, additional, Munder, Markus, additional, Nooka, Ajay K., additional, Mark, Tomer, additional, Quach, Hang, additional, Scott, Emma Catherine, additional, Lee, Je-Jung, additional, Sonneveld, Pieter, additional, Casneuf, Tineke, additional, Chiu, Christopher, additional, Qin, Xiang, additional, Amin, Himal, additional, Thiyagarajah, Piruntha, additional, Schecter, Jordan Mark, additional, Qi, Ming, additional, and Spencer, Andrew, additional

Published
2017
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24. Daratumumab, Bortezomib and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in RRMM Based on Prior Lines and Treatment Exposure: CASTOR

Author

Lentzsch, Suzanne, primary, Nooka, Ajay, additional, Quach, Hang, additional, Lee, Cindy, additional, Barreto, Wolney, additional, Corradini, Paolo, additional, Min, Chang Ki, additional, Scott, Emma, additional, Chanan-Khan, Asher, additional, Horvath, Noemi, additional, Capra, Marcelo, additional, Beksac, Meral, additional, Ovilla, Roberto, additional, Jo, Jae-Cheol, additional, Shin, Ho-Jin, additional, Soong, David, additional, Casneuf, Tineke, additional, Chiu, Christopher, additional, Qin, Xiang, additional, Amin, Himal, additional, Sonneveld, Pieter, additional, Schecter, Jordan, additional, Sasser, Kate, additional, Qi, Ming, additional, and Mateos, Maria-Victoria, additional

Published
2017
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25. Daratumumab, Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Based on Prior Treatment Exposure: Updated Efficacy Analysis of Castor

Author

Chanan-Khan, Asher A., primary, Lentzsch, Suzanne, additional, Quach, Hang, additional, Horvath, Noemi, additional, Capra, Marcelo, additional, Ovilla, Roberto, additional, Jo, Jae-Cheol, additional, Shin, Ho-Jin, additional, Qi, Ming, additional, Deraedt, William, additional, Schecter, Jordan, additional, Amin, Himal, additional, Qin, Xiang, additional, Casneuf, Tineke, additional, Chiu, Christopher, additional, Sasser, A. Kate, additional, and Sonneveld, Pieter, additional

Published
2016
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26. Efficacy of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Myeloma Based on Prior Lines of Therapy: Updated Analysis of Castor

Author

Mateos, Maria-Victoria, primary, Estell, Jane, additional, Barreto, Wolney, additional, Corradini, Paolo, additional, Min, Chang-Ki, additional, Medvedova, Eva, additional, Qi, Ming, additional, Schecter, Jordan, additional, Amin, Himal, additional, Qin, Xiang, additional, Deraedt, William, additional, Casneuf, Tineke, additional, Chiu, Christopher, additional, Sasser, A. Kate, additional, and Nooka, Ajay, additional

Published
2016
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27. Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study.

Author

Palumbo, Antonio, primary, Chanan-Khan, Asher Alban Akmal, additional, Weisel, Katja, additional, Nooka, Ajay K., additional, Masszi, Tamas, additional, Beksac, Meral, additional, Spicka, Ivan, additional, Hungria, Vania T.M., additional, Mateos, María-Victoria, additional, Mark, Tomer Martin, additional, Qi, Ming, additional, Schecter, Jordan Mark, additional, Amin, Himal, additional, Qin, Xiang, additional, Deraedt, William, additional, Ahmadi, Tahamtan, additional, Spencer, Andrew, additional, and Sonneveld, Pieter, additional

Published
2016
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28. Twin randomized studies of daratumumab (DARA; D) plus standard of care (lenalidomide/dexamethasone or bortezomib/dexamethasone [DRd or DVd]) versus Rd or Vd alone in relapsed or refractory multiple myeloma (MM): 54767414MMY3003 (Pollux) and 54767414MMY3004 (Castor).

Author

Palumbo, Antonio, primary, Dimopoulos, Meletios A., additional, Reece, Donna Ellen, additional, Sonneveld, Pieter, additional, Spencer, Andrew, additional, Chanan-Khan, Asher Alban Akmal, additional, Goldschmidt, Hartmut, additional, Yeh, Howard, additional, Schecter, Jordan Mark, additional, Qin, Xiang, additional, Amin, Himal, additional, Guckert, Mary E., additional, Ahmadi, Tahamtan, additional, and Orlowski, Robert Z., additional

Published
2015
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30. Daratumumab plus bortezomib and dexamethasone versus bortezomib and dexamethasone in relapsed or refractory multiple myeloma: updated analysis of CASTOR

Author

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

Subjects
Oncology, medicine.medical_specialty, Phases of clinical research, Cytogenetics and Molecular Genetic, 03 medical and health sciences, 0302 clinical medicine, Median follow-up, Internal medicine, hemic and lymphatic diseases, Medicine, Multiple myeloma, Dexamethasone, Minimal Residual Disease, business.industry, Bortezomib, Hazard ratio, Daratumumab, Hematology, prior therapy, medicine.disease, Minimal residual disease, 030220 oncology & carcinogenesis, Quality of Life, business, Multiple Myeloma, 030215 immunology, medicine.drug
Abstract

Daratumumab, a CD38 human monoclonal antibody, demonstrated significant clinical activity in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in the primary analysis of CASTOR, a phase 3 study in relapsed and/or refractory multiple myeloma. A post hoc analysis based on treatment history and longer follow-up is presented. After 19.4 (range: 0 to 27.7) months of median follow-up, daratumumab plus bortezomib and dexamethasone prolonged progression-free survival (median: 16.7 versus 7.1 months; hazard ratio, 0.31; 95% confidence interval, 0.24-0.39; P 12, ≤6, or >6 months), or cytogenetic risk. Minimal residual disease-negative rates were >2.5-fold higher with daratumumab across subgroups. The safety profile of daratumumab plus bortezomib and dexamethasone remained consistent with longer follow-up. Daratumumab plus bortezomib and dexamethasone demonstrated significant clinical activity across clinically relevant subgroups and provided the greatest benefit to patients treated at first relapse.

Published
2018

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