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1. P1282: MOCRAVIMOD IMPROVES OVERALL SURVIVAL IN AML PATIENTS UNDERGOING ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION

Author

Medinger, Michael, primary, Passweg, Jakob, additional, Bucher, Christoph, additional, Finke, Juergen, additional, Schanz, Urs, additional, Stylianou, Christos, additional, Dertschnig, Simone, additional, Souquières, Malika, additional, Oehen, Stephan, additional, Kueenburg, Elisabeth, additional, and Heim, Dominik, additional

Published
2023
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2. MO-TRANS: A Phase 2b Placebo-Controlled Study of Mocravimod As Adjunctive and Maintenance Treatment in AML Patients Undergoing Allogeneic Hematopoietic Cell Transplant

Author

de Lima, Marcos, primary, Malard, Florent, additional, Olavarria, Eduardo, additional, Pérez López, Estefanía, additional, Medinger, Michael, additional, Kueenburg, Elisabeth, additional, Souquieres, Malika, additional, Cachat, Julien, additional, Stylianou, Christos, additional, and Chevallier, Patrice, additional

Published
2022
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3. Iberdomide (IBER) in Combination with Dexamethasone (DEX) in Patients (pts) with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Dose-Expansion Phase of the CC-220-MM-001 Trial

Author

Lonial, Sagar, primary, Popat, Rakesh, additional, Hulin, Cyrille, additional, Jagannath, Sundar, additional, Oriol, Albert, additional, Richardson, Paul G., additional, Facon, Thierry, additional, Weisel, Katja, additional, Larsen, Jeremy T., additional, Minnema, Monique C., additional, Abdallah, Al-Ola, additional, Badros, Ashraf Z., additional, Knop, Stefan, additional, Stadtmauer, Edward A., additional, Chen, Min, additional, Nguyen, Tuong Vi, additional, Amin, Alpesh, additional, Kueenburg, Elisabeth, additional, Peluso, Teresa, additional, and van de Donk, Niels W.C.J., additional

Published
2021
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4. OAB-013: Iberdomide (IBER) in combination with dexamethasone (DEX) and daratumumab (DARA), bortezomib (BORT), or carfilzomib (CFZ) in patients (pts) with relapsed/refractory multiple myeloma (RRMM)

Author

Lonial, Sagar, primary, Richardson, Paul G., additional, Popat, Rakesh, additional, Stadtmauer, Edward A., additional, Larsen, Jeremy T., additional, Oriol, A., additional, Knop, Stefan, additional, Jagannath, Sundar, additional, Cook, Gordon, additional, Badros, Ashraf Z., additional, Rodríguez-Otero, Paula, additional, Siegel, David S., additional, Nguyen, Tuong Vi, additional, Micco, Antonia Di, additional, Amin, Alpesh, additional, Chen, Min, additional, Kueenburg, Elisabeth, additional, and van de Donk, Niels W.C.J., additional

Published
2021
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5. P-203: EXCALIBER: a phase 3 study comparing iberdomide, daratumumab, and dexamethasone (IberDd) with daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma

Author

Lonial, Sagar, primary, Berdeja, Jesus G., additional, Dimopoulos, Meletios-Athanasios, additional, Jagannath, Sundar, additional, Knop, Stefan, additional, Quach, Hang, additional, Rodríguez-Otero, Paula, additional, Richardson, Paul G., additional, Sorrell, April, additional, Chen, Min, additional, Kueenburg, Elisabeth, additional, Nguyen, Tuong Vi, additional, Hong, Kevin, additional, Peluso, Teresa, additional, and van de Donk, Niels W.C.J., additional

Published
2021
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7. A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Gamberi, Barbara, Berthou, Christian, Hernandez, Miguel, Semenzato, Gianpietro, Tholouli, Eleni, Hájek, Roman, Caers, Jo, Dimopoulos, Meletios, Minnema, Monique C, Andreasson, Bjorn, Parreira, Joana, Crotty, Gerard, Remes, Kari, Kueenburg, Elisabeth, Rosettani, Barbara, Di Micco, Antonia, Peters, Sarah, Bacon, Pamela, Blau, Igor Wolfgang, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Gamberi, Barbara, Berthou, Christian, Hernandez, Miguel, Semenzato, Gianpietro, Tholouli, Eleni, Hájek, Roman, Caers, Jo, Dimopoulos, Meletios, Minnema, Monique C, Andreasson, Bjorn, Parreira, Joana, Crotty, Gerard, Remes, Kari, Kueenburg, Elisabeth, Rosettani, Barbara, Di Micco, Antonia, Peters, Sarah, Bacon, Pamela, and Blau, Igor Wolfgang

Published
2020

8. First Results of Iberdomide (IBER; CC-220) in Combination with Dexamethasone (DEX) and Daratumumab (DARA) or Bortezomib (BORT) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

van de Donk, Niels W.C.J., primary, Popat, Rakesh, additional, Larsen, Jeremy, additional, Minnema, Monique C., additional, Jagannath, Sundar, additional, Oriol, Albert, additional, Zonder, Jeffrey, additional, Richardson, Paul G., additional, Rodriguez-Otero, Paula, additional, Badros, Ashraf Z., additional, Stadtmauer, Edward, additional, Bringhen, Sara, additional, Campagnaro, Erica, additional, Siegel, David S., additional, Gamberi, Barbara, additional, Gironella Mesa, Mercedes, additional, Sonneveld, Pieter, additional, Nguyen, Tuong Vi, additional, Di Micco, Antonia, additional, Sorrell, April, additional, Chen, Min, additional, Amatangelo, Michael, additional, Kueenburg, Elisabeth, additional, and Lonial, Sagar, additional

Published
2020
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9. A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

Author

Gamberi, Barbara, primary, Berthou, Christian, additional, Hernandez, Miguel, additional, Semenzato, Gianpietro, additional, Tholouli, Eleni, additional, Hájek, Roman, additional, Caers, Jo, additional, Dimopoulos, Meletios, additional, Minnema, Monique C., additional, Andreasson, Bjorn, additional, Parreira, Joana, additional, Crotty, Gerard, additional, Remes, Kari, additional, Kueenburg, Elisabeth, additional, Rosettani, Barbara, additional, Di Micco, Antonia, additional, Peters, Sarah, additional, Bacon, Pamela, additional, and Blau, Igor Wolfgang, additional

Published
2020
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10. Safety Profile for Lenalidomide-Based and Non-Lenalidomide-Based First-Line Therapy for Multiple Myeloma in Transplant Ineligible Patients: Real-World Evidence from a European Post-Authorization Safety Study

Author

Cavo, Michele, primary, De Stefano, Valerio, additional, Ramirez Payer, Angel, additional, Wiesholzer, Martin, additional, Tromp, Yvonne, additional, Vanstraelen, Gaëtan, additional, Schaedlich, Baerbel, additional, Valentine, Richez, additional, Dhanasiri, Sujith, additional, Kueenburg, Elisabeth, additional, Rosettani, Barbara, additional, Martin, Claire, additional, Pozzi, Stefano, additional, Bacon, Pamela, additional, and Gamberi, Barbara, additional

Published
2019
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12. Pomalidomide-based treatment in relapsed refractory mulitiple myeloma: Analysis of baseline characteristics and safety profile of patients who died in the European post approval safety study: PS1418

Author

Kueenburg Elisabeth, Barbara Rosettani, Torben Plesner, Pamela Bacon, Charalampia Kyriakou, Barbara Gamberi, Francesco Di Raimondo, Angel Ramirez Payer, Martin Schmidt Hieber, Niels Abildgaard, Margaret Atiba-Davies, and Antonia Di Micco

Subjects
Oncology, Safety profile, medicine.medical_specialty, business.industry, Internal medicine, Baseline characteristics, Relapsed refractory, medicine, Hematology, Pomalidomide, business, medicine.drug
Published
2019

16. Post-Authorization Safety Study of Lenalidomide-Based vs Non–Lenalidomide-Based Treatment in Transplant-Ineligible Newly Diagnosed Multiple Myeloma

Author

Cavo, Michele, primary, De Stefano, Valerio, additional, Payer, Angel Ramirez, additional, Bilgin, Yavuz, additional, Pichler, Petra, additional, Ziske, Carsten, additional, Kueenburg, Elisabeth, additional, Di Micco, Antonia, additional, Rosettani, Barbara, additional, Pozzi, Stefano, additional, Bacon, Pamela, additional, and Gamberi, Barbara, additional

Published
2019
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17. European Post-Authorization Safety Study of Patients With Relapsed or Refractory Multiple Myeloma Treated With Pomalidomide in a Real-World Setting

Author

Gamberi, Barbara, primary, Albildgaard, Niels, additional, Vekemans, Marie-Christiane, additional, Payer, Angel Ramirez, additional, Kyriakou, Charalampia, additional, Di Raimondo, Francesco, additional, Kueenburg, Elisabeth, additional, Di Micco, Antonia, additional, Rosettani, Barbara, additional, Atiba-Davies, Margaret, additional, Bacon, Pamela, additional, and Plesner, Torben, additional

Published
2019
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18. Pomalidomide and Dexamethasone Treatment for ≥ 1 Year in Renally Impaired Patients With Relapsed or Refractory Multiple Myeloma

Author

Weisel, Katja, primary, Dimopoulos, Meletios A., additional, Cook, Mark, additional, Ramasamy, Karthik, additional, Rubia, Javier De La, additional, Ardizzoia, Antonio, additional, Krauth, Maria Theresa, additional, JACCARD, Arnaud, additional, Van de Donk, Niels, additional, Kueenburg, Elisabeth, additional, Di Micco, Antonia, additional, Rosettani, Barbara, additional, Atiba-Davies, Margaret, additional, Bacon, Pamela, additional, and Sonneveld, Pieter, additional

Published
2019
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19. Safety in Patients with Multiple Myeloma Treated with Pomalidomide in a Real-World Setting According to Last Prior Treatment: A European Post-Authorization Safety Study

Author

Abildgaard, Niels, primary, Vekemans, Marie-Christiane, additional, Gamberi, Barbara, additional, Di Raimondo, Francesco, additional, Ramirez Payer, Angel, additional, Kyriakou, Charalampia, additional, Kentos, Alain, additional, Kueenburg, Elisabeth, additional, Di Micco, Antonia, additional, Rosettani, Barbara, additional, Bacon, Pamela, additional, Atiba-Davies, Margaret, additional, and Plesner, Torben, additional

Published
2018
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22. Pomalidomide Plus Low-Dose Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma and Renal Impairment: Results From a Phase II Trial

Author

Dimopoulos, Meletios, primary, Weisel, Katja, additional, van de Donk, Niels W.C.J., additional, Ramasamy, Karthik, additional, Gamberi, Barbara, additional, Streetly, Matthew, additional, Offidani, Massimo, additional, Bridoux, Frank, additional, de la Rubia, Javier, additional, Mateos, Maria-Victoria, additional, Ardizzoia, Antonio, additional, Kueenburg, Elisabeth, additional, Collins, Shona, additional, Di Micco, Antonia, additional, Rosettani, Barbara, additional, Li, Yan, additional, Bacon, Pamela, additional, and Sonneveld, Pieter, additional

Published
2018
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23. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function

Author

Li, Yan, primary, Wang, Xiaomin, additional, O’Mara, Edward, additional, Dimopoulos, Meletios, additional, Sonneveld, Pieter, additional, Weisel, Katja, additional, Matous, Jeffrey, additional, Siegel, David, additional, Shah, Jatin, additional, Kueenburg, Elisabeth, additional, Sternas, Lars, additional, Cavanaugh, Chloe, additional, Zaki, Mohamed, additional, Palmisano, Maria, additional, and Zhou, Simon, additional

Published
2017
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24. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function

Author

Li,Yan, Wang,Xiaomin, O’Mara,Edward, Dimopoulos,Meletios, Sonneveld,Pieter, Weisel,Katja, Matous,Jeffrey, Siegel,David, Shah,Jatin, Kueenburg,Elisabeth, Sternas,Lars, Cavanaugh,Chloe, Zaki,Mohamed, Palmisano,Maria, Zhou,Simon, Li,Yan, Wang,Xiaomin, O’Mara,Edward, Dimopoulos,Meletios, Sonneveld,Pieter, Weisel,Katja, Matous,Jeffrey, Siegel,David, Shah,Jatin, Kueenburg,Elisabeth, Sternas,Lars, Cavanaugh,Chloe, Zaki,Mohamed, Palmisano,Maria, and Zhou,Simon

Abstract

Yan Li,1 Xiaomin Wang,2 Edward O’Mara,1 Meletios A Dimopoulos,3 Pieter Sonneveld,4 Katja C Weisel,5 Jeffrey Matous,6 David S Siegel,7 Jatin J Shah,8 Elisabeth Kueenburg,9 Lars Sternas,9 Chloe Cavanaugh,9 Mohamed Zaki,9 Maria Palmisano,1 Simon Zhou1 1Translational Development and Clinical Pharmacology, Celgene Corporation, Summit, NJ, USA; 2Non-Clinical Development and Drug Metabolism and Pharmacokinetics, Celgene Corporation, Summit, NJ, USA; 3Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Athens, Greece; 4Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands; 5Department of Hematology, University Hospital Tübingen, Tübingen, Germany; 6Department of Hematology/Oncology, Colorado Blood Cancer Institute, Denver, CO, USA; 7Myeloma Division, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA; 8Department of Lymphoma/Myeloma, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, USA; 9Global Clinical R&D, Celgene Corporation, Summit, NJ, USA Abstract: Pomalidomide is an immunomodulatory drug for treatment of relapsed or refractory multiple myeloma (rrMM) in patients who often have comorbid renal conditions. To assess the impact of renal impairment on pomalidomide exposure, a population pharmacokinetics (PPK) model of pomalidomide in rrMM patients with various degrees of impaired renal function was developed. Intensive and sparse pomalidomide concentration data collected from two clinical studies in rrMM patients with normal renal function, moderately impaired renal function, severely impaired renal function not requiring dialysis, and with severely impaired renal function requiring dialysis were pooled over the dose range of 2 to 4 mg, to assess specifically the influence of the impaired renal function as a categorical variable and a continuous variable on pomalidomide clearance and plasma exposure. In addition

Published
2017

26. European Post-Approval Safety Study (EU Pass) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety In Patients (Pts) Treated With Pomalidomide (POM)

Author

Di Raimondo, Francesco, primary, Kyriakou, Charalampia, additional, Schmidt-Hieber, Martin, additional, Vekemans, Marie-Christiane, additional, Payer, Angel Ramirez, additional, Bentsen, Pal Tore, additional, Lauri, Birgitta, additional, Kueenburg, Elisabeth, additional, Atiba-Davies, Margaret, additional, Lersch, Frederik, additional, Rosettani, Barbara, additional, Bacon, Pamela, additional, and Plesner, Torben, additional

Published
2017
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27. Phase 2 Multicenter Study of Pomalidomide (POM) Plus Low-Dose Dexamethasone (LoDEX) in Patients (Pts) With Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment (RI): An Updated Safety Analysis

Author

Weisel, Katja, primary, Dimopoulos, Meletios Athanasios, additional, Van de Donk, Niels, additional, Ramasamy, Karthik, additional, Gamberi, Barbara, additional, Streetly, Matthew, additional, Offidani, Massimo, additional, Bridoux, Frank, additional, Rubia, Javier de la, additional, Kueenburg, Elisabeth, additional, Collins, Shona, additional, Lersch, Frederik, additional, Rosettani, Barbara, additional, Bacon, Pamela, additional, and Sonneveld, Pieter, additional

Published
2017
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28. European Post-Approval Safety Study (EU Pass) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety, Including Second Primary Malignancies, in a Large Cohort of Patients (Pts) Treated With Lenalidomide (LEN), Thalidomide (THAL), and Bortezomib (BORT)

Author

Gamberi, Barbara, primary, Hernandez, Miguel T., additional, Berthou, Christian, additional, Tholouli, Eleni, additional, Zamagni, Elena, additional, Hajek, Roman, additional, Minnema, Monique, additional, Dimopoulos, Meletios Athanasios, additional, Caers, Jo, additional, Andersen, Niels Frost, additional, Andreasson, Bjorn, additional, Waage, Anders, additional, Crotty, Gerard, additional, Kueenburg, Elisabeth, additional, Rosettani, Barbara, additional, Di Micco, Antonio, additional, Bacon, Pamela, additional, and Blau, Igor Wolfgang, additional

Published
2017
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29. European Post-Approval Safety Study (PASS) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety, Including SPM, in a Large Cohort of Patients Treated with Lenalidomide, Thalidomide, and Bortezomib

Author

Gamberi, Barbara, primary, Hernandez, Miguel, additional, Berthou, Christian, additional, Tholouli, Eleni, additional, Zamagni, Elena, additional, Hájek, Roman, additional, Minnema, Monique, additional, Dimopoulos, Meletios A, additional, Caers, Jo, additional, Frost Andersen, Niels, additional, Andreasson, Bjorn, additional, Waage, Anders, additional, Crotty, Gerard, additional, Kueenburg, Elisabeth, additional, Rosettani, Barbara, additional, Di Micco, Antonia, additional, Bacon, Pamela, additional, and Blau, Igor, additional

Published
2016
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30. Safety Results of a Phase 2 Multicenter, Open-Label Study of Pomalidomide (CC-4047) Plus Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment

Author

Weisel, Katja, primary, Dimopoulos, Meletios A, additional, van de Donk, Niels W.C.J., additional, Ramasamy, Karthik, additional, Gamberi, Barbara, additional, Streetly, Matthew, additional, Offidani, Massimo, additional, Bridoux, Frank, additional, de la Rubia, Javier, additional, Kueenburg, Elisabeth, additional, Lersch, Frederik, additional, Rosettani, Barbara, additional, Bacon, Pamela, additional, and Sonneveld, Pieter, additional

Published
2016
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31. European Post-Approval Safety Study (Registry) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety of Patients Treated with Pomalidomide

Author

Di Raimondo, Francesco, primary, Kyriakou, Charalampia, additional, Schmidt-Hieber, Martin, additional, Vekemans, Marie-Christiane, additional, Ramírez Payer, Ángel, additional, Bentsen, Pal Tore, additional, Lauri, Birgitta, additional, Kueenburg, Elisabeth, additional, Lersch, Frederik, additional, Rosettani, Barbara, additional, Bacon, Pamela, additional, and Plesner, Torben, additional

Published
2016
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33. Safety of Treatment (Tx) with Pomalidomide (POM) and Low-Dose Dexamethasone (LoDEX) in Patients (Pts) with Relapsed or Refractory Multiple Myeloma (RRMM) and Renal Impairment (RI), Including Those on Dialysis

Author

Ramasamy, Karthik, primary, Dimopoulos, Meletios A., additional, van de Donk, Niels W.C.J., additional, Gamberi, Barbara, additional, Bridoux, Frank, additional, Streetly, Matthew, additional, Kueenburg, Elisabeth, additional, Rosettani, Barbara, additional, Collins, Shona, additional, Lersch, Frederik, additional, Bacon, Pamela, additional, Weisel, Katja C., additional, and Sonneveld, Pieter, additional

Published
2015
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34. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function.

Author

Yan Li, Xiaomin Wang, O’Mara, Edward, Dimopoulos, Meletios A., Sonneveld, Pieter, Weisel, Katja C., Matous, Jeffrey, Siegel, David S., Shah, Jatin J., Kueenburg, Elisabeth, Sternas, Lars, Cavanaugh, Chloe, Zaki, Mohamed, Palmisano, Maria, and Zhou, Simon

Subjects
MULTIPLE myeloma treatment, PHARMACOKINETICS, HEMODIALYSIS, DISEASE relapse, BLOOD circulation, KIDNEY function tests
Abstract

Pomalidomide is an immunomodulatory drug for treatment of relapsed or refractory multiple myeloma (rrMM) in patients who often have comorbid renal conditions. To assess the impact of renal impairment on pomalidomide exposure, a population pharmacokinetics (PPK) model of pomalidomide in rrMM patients with various degrees of impaired renal function was developed. Intensive and sparse pomalidomide concentration data collected from two clinical studies in rrMM patients with normal renal function, moderately impaired renal function, severely impaired renal function not requiring dialysis, and with severely impaired renal function requiring dialysis were pooled over the dose range of 2 to 4 mg, to assess specifically the influence of the impaired renal function as a categorical variable and a continuous variable on pomalidomide clearance and plasma exposure. In addition, pomalidomide concentration data collected on dialysis days from both the withdrawal (arterial) side and from the returning (venous) side of the dialyzer, from rrMM patients with severely impaired renal function requiring dialysis, were used to assess the extent to which dialysis contributes to the removal of pomalidomide from blood circulation. PPK analyses demonstrated that moderate to severe renal impairment not requiring dialysis has no influence on pomalidomide clearance or plasma exposure, as compared to those patients with normal renal function, while pomalidomide exposure increased approximately 35% in patients with severe renal impairment requiring dialysis on nondialysis days. In addition, dialysis increased total body pomalidomide clearance from 5 L/h to 12 L/h, indicating that dialysis will significantly remove pomalidomide from the blood circulation. Thus, pomalidomide should be administered post-dialysis on the days of dialysis. [ABSTRACT FROM AUTHOR]

Published
2017
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36. MM-013: An ongoing phase 2 trial of pomalidomide and low-dose dexamethasone (POM + LoDEX) in relapsed/refractory multiple myeloma (RRMM) with moderate or severe renal impairment (RI) including patients (pts) undergoing hemodialysis.

Author

Sonneveld, Pieter, primary, Heyne, Nils, additional, Kueenburg, Elisabeth, additional, Glasmacher, Axel G., additional, Kasserra, Claudia, additional, Rosettani, Barbara, additional, Bacon, Pamela Joy, additional, and Weisel, Katja C., additional

Published
2014
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37. Post-Approval Safety Study (PASS) of Lenalidomide Compared with Other Treatments in Patients with Relapsed or Refractory Multiple Myeloma

Author

Cavo, Michele, primary, Masini, Luciano, additional, Blau, Igor W., additional, Hernandez, Miguel T., additional, Zambello, Renato, additional, de Fabritiis, Paolo, additional, Berthou, Christian, additional, Symeonidis, Argiris, additional, Bird, Jennifer, additional, De La Rubia, Javier, additional, Bacon, Pamela, additional, Rosettani, Barbara, additional, Kueenburg, Elisabeth, additional, and Minton, Neil, additional

Published
2011
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38. OPTIMUM Dose of Thalidomide for Relapsed Multiple Myeloma.

Author

Kropff, Martin, primary, Baylon, Honorata Giongco, additional, Hillengass, Jens, additional, Robak, Tadeusz, additional, Hajek, Roman, additional, Liebisch, Peter, additional, Goranov, Stefan, additional, Hulin, Cyrille, additional, Blade, Joan, additional, Caravita, Tomaso, additional, Avet-Loiseau, Herve, additional, Moehler, Thomas M., additional, Pattou, Claire, additional, Lucy, Lela, additional, Kueenburg, Elisabeth, additional, Glasmacher, Axel, additional, Zerbib, Robert, additional, and Facon, Thierry, additional

Published
2009
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40. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function.

Author

Li Y, Wang X, O'Mara E, Dimopoulos MA, Sonneveld P, Weisel KC, Matous J, Siegel DS, Shah JJ, Kueenburg E, Sternas L, Cavanaugh C, Zaki M, Palmisano M, and Zhou S

Abstract

Pomalidomide is an immunomodulatory drug for treatment of relapsed or refractory multiple myeloma (rrMM) in patients who often have comorbid renal conditions. To assess the impact of renal impairment on pomalidomide exposure, a population pharmacokinetics (PPK) model of pomalidomide in rrMM patients with various degrees of impaired renal function was developed. Intensive and sparse pomalidomide concentration data collected from two clinical studies in rrMM patients with normal renal function, moderately impaired renal function, severely impaired renal function not requiring dialysis, and with severely impaired renal function requiring dialysis were pooled over the dose range of 2 to 4 mg, to assess specifically the influence of the impaired renal function as a categorical variable and a continuous variable on pomalidomide clearance and plasma exposure. In addition, pomalidomide concentration data collected on dialysis days from both the withdrawal (arterial) side and from the returning (venous) side of the dialyzer, from rrMM patients with severely impaired renal function requiring dialysis, were used to assess the extent to which dialysis contributes to the removal of pomalidomide from blood circulation. PPK analyses demonstrated that moderate to severe renal impairment not requiring dialysis has no influence on pomalidomide clearance or plasma exposure, as compared to those patients with normal renal function, while pomalidomide exposure increased approximately 35% in patients with severe renal impairment requiring dialysis on nondialysis days. In addition, dialysis increased total body pomalidomide clearance from 5 L/h to 12 L/h, indicating that dialysis will significantly remove pomalidomide from the blood circulation. Thus, pomalidomide should be administered post-dialysis on the days of dialysis., Competing Interests: Disclosure Yan Li, Xiaomin Wang, Edward O’Mara, Elisabeth Kueen-burg, Lars Sternas, Chloe Cavanaugh, Mohamed Zaki, Maria Palmisano, and Simon Zhou are employees of and hold equity ownership in Celgene Corporation; Meletios A Dimopoulos has received honoraria and consulting/advisory fees from Amgen, Celgene, Janssen, and Takeda; Pieter Sonneveld has received advisory/consultancy fees from Celgene, Amgen, Janssen, Karyopharm, and Skyline, and honoraria from Celgene, Amgen, Janssen, and Karyopharm; Katja C Weisel has received research funding from Celgene and Janssen and honoraria from Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Onyx, and Takeda, and has held advisory board membership for Amgen, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Onyx, and Takeda; Jeffrey Matous has received advisory/consultancy fees from Celgene and served on their speaker’s bureau; David S Siegel has served on speaker’s bureaus for Celgene, Amgen, Takeda, Merck, and Novartis; Jatin J Shah has received research funding from Bristol-Myers Squibb, Celgene, Amgen, Novartis, and Array, consulting fees from Bristol-Myers Squibb, Celgene, Takeda, and Novartis, and served on speaker’s bureaus for Bristol-Myers Squibb, Amgen, and Janssen. The authors report no other conflicts of interest.

Published
2017
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41. Thalidomide versus dexamethasone for the treatment of relapsed and/or refractory multiple myeloma: results from OPTIMUM, a randomized trial.

Author

Kropff M, Baylon HG, Hillengass J, Robak T, Hajek R, Liebisch P, Goranov S, Hulin C, Bladé J, Caravita T, Avet-Loiseau H, Moehler TM, Pattou C, Lucy L, Kueenburg E, Glasmacher A, Zerbib R, and Facon T

Subjects
Adult, Aged, Aged, 80 and over, Disease Progression, Female, Follow-Up Studies, Humans, International Agencies, Male, Middle Aged, Multiple Myeloma mortality, Multiple Myeloma pathology, Neoplasm Recurrence, Local mortality, Neoplasm Recurrence, Local pathology, Neoplasm Staging, Prognosis, Prospective Studies, Remission Induction, Salvage Therapy, Survival Rate, Angiogenesis Inhibitors therapeutic use, Antineoplastic Agents, Hormonal therapeutic use, Dexamethasone therapeutic use, Drug Resistance, Neoplasm, Multiple Myeloma drug therapy, Neoplasm Recurrence, Local drug therapy, Thalidomide therapeutic use
Abstract

Background: Thalidomide has potent antimyeloma activity, but no prospective, randomized controlled trial has evaluated thalidomide monotherapy in patients with relapsed/refractory multiple myeloma., Design and Methods: We conducted an international, randomized, open-label, four-arm, phase III trial to compare three different doses of thalidomide (100, 200, or 400 mg/day) with standard dexamethasone in patients who had received one to three prior therapies. The primary end-point was time to progression., Results: In the intent-to-treat population (N=499), the median time to progression was 6.1, 7.0, 7.6, and 9.1 months in patients treated with dexamethasone, and thalidomide 100, 200, and 400 mg/day, respectively; the difference between treatment groups was not statistically significant. In the per-protocol population (n=465), the median time to progression was 6.0, 7.0, 8.0, and 9.1 months, respectively. In patients who had received two or three prior therapies, thalidomide significantly prolonged the time to progression at all dose levels compared to the result achieved with dexamethasone. Response rates and median survival were similar in all treatment groups, but the median duration of response was significantly longer in all thalidomide groups than in the dexamethasone group. Adverse events reported in the thalidomide groups, such as fatigue, constipation and neuropathy, confirmed the known safety profile of thalidomide., Conclusions: Although thalidomide was not superior to dexamethasone in this randomized trial, thalidomide monotherapy may be considered an effective salvage therapy option for patients with relapsed/refractory multiple myeloma, particularly those with a good prognosis and those who have received two or three prior therapies. The recommended starting dose of thalidomide monotherapy is 400 mg/day, which can be rapidly reduced for patients who do not tolerate this treatment. (, Clinical Trial Registration Number: NCT00452569).

Published
2012
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