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1. Health-related quality of life and quality-adjusted progression free survival for carfilzomib and dexamethasone maintenance following salvage autologous stem-cell transplantation in patients with multiple myeloma: a randomized phase 2 trial by the Nordic Myeloma Study Group

Author

Nielsen, Lene Kongsgaard, Schjesvold, Fredrik, Möller, Sören, Guldbrandsen, Nina, Hansson, Markus, Remes, Kari, Peceliunas, Valdas, Abildgaard, Niels, Gregersen, Henrik, and King, Madeleine T.

Published
2024
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2. Longitudinal minimal residual disease assessment in multiple myeloma patients in complete remission – results from the NMSG flow-MRD substudy within the EMN02/HO95 MM trial

Author

Schmitz, Alexander, Brøndum, Rasmus Froberg, Johnsen, Hans Erik, Mellqvist, Ulf-Henrik, Waage, Anders, Gimsing, Peter, op Bruinink, Davine Hofste, van der Velden, Vincent, van der Holt, Bronno, Hansson, Markus, Andersen, Niels Frost, Frølund, Ulf Christian, Helleberg, Carsten, Schjesvold, Fredrik H., Ahlberg, Lucia, Gulbrandsen, Nina, Andreasson, Bjorn, Lauri, Birgitta, Haukas, Einar, Bødker, Julie Støve, Roug, Anne Stidsholt, Bøgsted, Martin, Severinsen, Marianne T., Gregersen, Henrik, Abildgaard, Niels, Sonneveld, Pieter, and Dybkær, Karen

Published
2022
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4. Strategies to improve patient-reported outcome completion rates in longitudinal studies

Author

Nielsen, Lene Kongsgaard, King, Madeleine, Möller, Sören, Jarden, Mary, Andersen, Christen Lykkegaard, Frederiksen, Henrik, Gregersen, Henrik, Klostergaard, Anja, Steffensen, Morten Saaby, Pedersen, Per Trøllund, Hinge, Maja, Frederiksen, Mikael, Jensen, Bo Amdi, Helleberg, Carsten, Mylin, Anne Kærsgaard, and Abildgaard, Niels

Published
2020

6. P-050 GEN3014 (HexaBody-CD38) versus daratumumab in patients with relapsed/ refractory multiple myeloma: design of randomized head-to-head expansion cohort of phase 1/2 trial

Author

Grosicki, Sebastian, primary, Dhakal, Binod, additional, Malek, Ehsan, additional, Creignou, Maria, additional, Jurczak, Wojciech, additional, Broijl, Annemiek, additional, Iversen, Katrine Fladeland, additional, Gregersen, Henrik, additional, Radocha, Jakub, additional, Chen, Jenny, additional, Ogunkanmi, Adeleye, additional, and Spencer, Andrew, additional

Published
2023
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7. P817: VALIDATION OF THE SECOND REVISED INTERNATIONAL STAGING SYSTEM (R2-ISS) IN A LARGE POPULATION-BASED, NATIONWIDE COHORT OF PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

Author

Brieghel, Christian, primary, Nørgaard Andersen, Morten, additional, Grønne Jørgensen, Nicolai, additional, Silkjær, Trine, additional, Lund, Thomas, additional, Hinge, Maja, additional, Gregersen, Henrik, additional, Schou Pedersen, Robert, additional, Szabo, Agoston, additional, and Niemann, Carsten, additional

Published
2023
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8. P1671: CARFILZOMIB-DEXAMETHASONE MAINTENANCE HAMPERS RECOVERY AFTER SALVAGE AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Author

Nielsen, Lene Kongsgaard, primary, Schjesvold, Fredrik, additional, Möller, Sören, additional, Guldbrandsen, Nina, additional, Hansson, Markus, additional, Remes, Kari, additional, Pečeliūnas, Valdas, additional, Gregersen, Henrik, additional, King, Madeleine, additional, and Abildgaard, Niels, additional

Published
2023
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11. Geographical and ecological analyses of multiple myeloma in Denmark:Identification of potential hotspot areas and impact of urbanisation

Author

Bertelsen, Lise Dueholm, Børty Nielsen, Lars, Christensen, Heidi Søgaard, Bøgsted, Martin, Gregersen, Henrik, Pedersen, Robert Schou, Klostergaard, Anja, Schnack, Brian Iversen, Pedersen, Per Trøllund, Abildgaard, Niels, Hermansen, Emil, Vangsted, Annette Juul, Severinsen, Marianne Tang, Bertelsen, Lise Dueholm, Børty Nielsen, Lars, Christensen, Heidi Søgaard, Bøgsted, Martin, Gregersen, Henrik, Pedersen, Robert Schou, Klostergaard, Anja, Schnack, Brian Iversen, Pedersen, Per Trøllund, Abildgaard, Niels, Hermansen, Emil, Vangsted, Annette Juul, and Severinsen, Marianne Tang

Abstract

Background: The aetiology of multiple myeloma (MM) is unknown but various environmental exposures are suspected as risk factors. We present the first paper analysing the geographical distribution of MM in Denmark at the municipal level to investigate variations that could be explained by environmental exposures. Methods: Patients diagnosed with MM in Denmark during 2005–2020 were identified from nationwide registries and grouped into the 98 Danish municipalities based on residence. The age- and sex-standardised incidence rate (SIR) of each municipality was compared to the national incidence in a funnel plot with 95% control limits. Differences in SIRs of rural, suburban, and urban areas were evaluated with incidence rate ratios. Results: In total, 5243 MM patients were included. Overall, we found a heterogeneous geographical distribution of MM and a potential hotspot in southern Denmark. This hotspot contains three municipalities with SIRs above the 95% control limit assuming considerably higher rate of MM compared to the national incidence rate. A significant higher SIR was found in rural areas compared to urban areas. Conclusion: The geographical distribution of MM in Denmark indicates that the risk of developing MM depends on place of residence probably due to environmental factors.

Published
2023

12. Dansk Myelomatose Database – Resumé af årsrapport 2021

Author

Hermansen, Emil, Kristensen, Ida Bruun, Gregersen, Henrik, Klostergaard, Anja, Jensen, Bo Amdi, Dravecká, Jana, Hinge, Maja, Pedersen, Robert Schou, Pedersen, Per Trøllund, Christiansen, Niklas Mølbak, Fredsted, Anne, and Steding-Jessen, Marianne

Published
2023

13. Geographical and ecological analyses of multiple myeloma in Denmark: Identification of potential hotspot areas and impact of urbanisation

Author

Bertelsen, Lise Dueholm, primary, Børty Nielsen, Lars, additional, Christensen, Heidi Søgaard, additional, Bøgsted, Martin, additional, Gregersen, Henrik, additional, Pedersen, Robert Schou, additional, Klostergaard, Anja, additional, Schnack, Brian Iversen, additional, Pedersen, Per Trøllund, additional, Abildgaard, Niels, additional, Hermansen, Emil, additional, Vangsted, Annette Juul, additional, and Severinsen, Marianne Tang, additional

Published
2022
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14. Preliminary Dose-Escalation Results from a Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Patients (pts) with Relapsed or Refractory Multiple Myeloma (RRMM)

Author

Spencer, Andrew, primary, Iversen, Katrine Fladeland, additional, Dhakal, Binod, additional, Creignou, Maria, additional, Chen, Jenny, additional, Hiemstra, Ida H, additional, Bosgra, Sieto, additional, Badani, Avani, additional, Breij, Esther C.W., additional, Brady, Lauren K., additional, Sasser, A. Kate, additional, Malmberg, Anders, additional, Gregersen, Henrik, additional, Hansson, Markus, additional, Broijl, Annemiek, additional, Mateos, Maria-Victoria, additional, and Plesner, Torben, additional

Published
2022
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15. Preliminary Dose-Escalation Results from a Phase 1/2 Study of GEN3014 (HexaBody (R)-CD38) in Patients (pts) with Relapsed or Refractory Multiple Myeloma (RRMM)

Author

Spencer, Andrew, Iversen, Katrine Fladeland, Dhakal, Binod, Creignou, Maria, Chen, Jenny, Hiemstra, Ida H, Bosgra, Sieto, Badani, Avani, Breij, Esther C. W., Brady, Lauren K., Sasser, A. Kate, Malmberg, Anders, Gregersen, Henrik, Hansson, Markus, Broijl, Annemiek, Mateos, Maria-Victoria, and Plesner, Torben

Subjects
Immunology, Cell Biology, Hematology, Biochemistry
Published
2022

16. A randomized placebo-controlled phase II study of clarithromycin or placebo combined with VCD induction therapy prior to high-dose melphalan with stem cell support in patients with newly diagnosed multiple myeloma

Author

Gregersen, Henrik, Do, Trung, Kristensen, Ida Bruun, Frølund, Ulf Christian, Andersen, Niels Frost, Nielsen, Lene Kongsgaard, Andersen, Christen Lykkegaard, Klausen, Tobias Wirenfeldt, Vangsted, Annette Juul, and Abildgaard, Niels

Published
2018
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17. Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma: a Nordic Myeloma Study Group randomized phase 3 trial

Author

Mellqvist, Ulf-Henrik, Gimsing, Peter, Hjertner, Oyvind, Lenhoff, Stig, Laane, Edward, Remes, Kari, Steingrimsdottir, Hlif, Abildgaard, Niels, Ahlberg, Lucia, Blimark, Cecilie, Dahl, Inger Marie, Forsberg, Karin, Gedde-Dahl, Tobias, Gregersen, Henrik, Gruber, Astrid, Guldbrandsen, Nina, Haukås, Einar, Carlson, Kristina, Kvam, Ann Kristin, Nahi, Hareth, Lindås, Roald, Andersen, Niels Frost, Turesson, Ingemar, Waage, Anders, and Westin, Jan

Published
2013
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18. Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma : A randomised phase 2 trial by the Nordic Myeloma Study Group

Author

Gregersen, Henrik, Peceliunas, Valdas, Remes, Kari, Schjesvold, Fredrik, Abildgaard, Niels, Nahi, Hareth, Andersen, Niels Frost, Vangsted, Annette Juul, Klausen, Tobias Wirenfeldt, Helleberg, Carsten, Carlson, Kristina, Frolund, Ulf Christian, Axelsson, Per, Stromberg, Olga, Blimark, Cecilie Hveding, Crafoord, Jacob, Tsykunova, Galina, Eshoj, Henrik Rode, Waage, Anders, Hansson, Markus, Gulbrandsen, Nina, Gregersen, Henrik, Peceliunas, Valdas, Remes, Kari, Schjesvold, Fredrik, Abildgaard, Niels, Nahi, Hareth, Andersen, Niels Frost, Vangsted, Annette Juul, Klausen, Tobias Wirenfeldt, Helleberg, Carsten, Carlson, Kristina, Frolund, Ulf Christian, Axelsson, Per, Stromberg, Olga, Blimark, Cecilie Hveding, Crafoord, Jacob, Tsykunova, Galina, Eshoj, Henrik Rode, Waage, Anders, Hansson, Markus, and Gulbrandsen, Nina

Abstract

Objective We investigated the efficacy and safety of carfilzomib-containing induction before salvage high-dose melphalan with autologous stem-cell transplantation (salvage ASCT) and maintenance with carfilzomib and dexamethasone after salvage ASCT in multiple myeloma. Methods This randomised, open-label, phase 2 trial included patients with first relapse of multiple myeloma after upfront ASCT who were re-induced with four cycles of carfilzomib, cyclophosphamide and dexamethasone. Two months after salvage, ASCT patients were randomised to either observation or maintenance therapy with iv carfilzomib 27 -> 56 mg/sqm and p.o. dexamethasone 20 mg every second week. The study enrolled 200 patients of which 168 were randomised to either maintenance with carfilzomib and dexamethasone (n = 82) or observation (n = 86). Results Median time to progression (TTP) after randomisation was 25.1 months (22.5-NR) in the carfilzomib-dexamethasone maintenance group and 16.7 months (14.4-21.8) in the control group (HR 0.46, 95% CI 0.30-0.71; P = .0004). The most common adverse events during maintenance were thrombocytopenia, anaemia, hypertension, dyspnoea and bacterial infections. Conclusion In summary, maintenance therapy with carfilzomib and dexamethasone after salvage ASCT prolonged TTP with 8 months. The maintenance treatment was in general well-tolerated with manageable toxicity.

Published
2022
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19. Outcome data from >10 000 multiple myeloma patients in the Danish and Swedish national registries

Author

Blimark, Cecilie Hveding, Vangsted, Annette Juul, Klausen, Tobias W., Gregersen, Henrik, Szabo, Agoston Gyula, Hermansen, Emil, Wålinder, Göran, Knut-Bojanowska, Dorota, Zang, Chenyang, Turesson, Ingemar, Blimark, Cecilie Hveding, Vangsted, Annette Juul, Klausen, Tobias W., Gregersen, Henrik, Szabo, Agoston Gyula, Hermansen, Emil, Wålinder, Göran, Knut-Bojanowska, Dorota, Zang, Chenyang, and Turesson, Ingemar

Abstract

Objective: We describe real-world evidence (RWE) from the nationwide Swedish and Danish registries that provide important information on incidence and outcome in multiple myeloma (MM). Method: First line treatment data on more than 10.000 MM patients from Denmark and Sweden between 2005–2018 are presented. Key results from research conducted within the Swedish and Danish myeloma registries are summarized, describing subgroups of patients with comorbidity, myeloma complications, and early relapse. Results: We show that national guidelines, generated on results from randomized clinical trials (RCTs) are rapidly implemented and improve overall survival (OS). We find that both the incidence of MM and the median age at diagnosis is higher in national registries compared to results from referral centres, indicating a more complete coverage. This highlights the need of validation of prognostic scoring systems and indices in e.g., SMM and high-risk MM in a real- world-population. We show that these subgroups are unlikely to be captured in RCTs with narrow inclusion and exclusion criteria, that they have worse survival, and are in need of new treatment approaches. Conclusion: National registries that include all MM patients are an important source of knowledge on epidemiology, treatment and outcome with implications for the planning of MM care. Despite the introduction of new and better treatments, rapidly implemented in our countries, our registries uncover subgroups of patients that still have inferior outcome. Our RWE can help to identify important research questions to be studied in further clinical trials also in patients currently not included in RCTs.

Published
2022

20. Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma:A randomised phase 2 trial by the Nordic Myeloma Study Group

Author

Gregersen, Henrik, Peceliunas, Valdas, Remes, Kari, Schjesvold, Fredrik, Abildgaard, Niels, Nahi, Hareth, Andersen, Niels Frost, Vangsted, Annette Juul, Klausen, Tobias Wirenfeldt, Helleberg, Carsten, Carlson, Kristina, Frølund, Ulf Christian, Axelsson, Per, Stromberg, Olga, Blimark, Cecilie Hveding, Crafoord, Jacob, Tsykunova, Galina, Eshoj, Henrik Rode, Waage, Anders, Hansson, Markus, Gulbrandsen, Nina, Gregersen, Henrik, Peceliunas, Valdas, Remes, Kari, Schjesvold, Fredrik, Abildgaard, Niels, Nahi, Hareth, Andersen, Niels Frost, Vangsted, Annette Juul, Klausen, Tobias Wirenfeldt, Helleberg, Carsten, Carlson, Kristina, Frølund, Ulf Christian, Axelsson, Per, Stromberg, Olga, Blimark, Cecilie Hveding, Crafoord, Jacob, Tsykunova, Galina, Eshoj, Henrik Rode, Waage, Anders, Hansson, Markus, and Gulbrandsen, Nina

Abstract

Objective: We investigated the efficacy and safety of carfilzomib-containing induction before salvage high-dose melphalan with autologous stem-cell transplantation (salvage ASCT) and maintenance with carfilzomib and dexamethasone after salvage ASCT in multiple myeloma. Methods: This randomised, open-label, phase 2 trial included patients with first relapse of multiple myeloma after upfront ASCT who were re-induced with four cycles of carfilzomib, cyclophosphamide and dexamethasone. Two months after salvage, ASCT patients were randomised to either observation or maintenance therapy with iv carfilzomib 27 → 56 mg/sqm and p.o. dexamethasone 20 mg every second week. The study enrolled 200 patients of which 168 were randomised to either maintenance with carfilzomib and dexamethasone (n = 82) or observation (n = 86). Results: Median time to progression (TTP) after randomisation was 25.1 months (22.5-NR) in the carfilzomib-dexamethasone maintenance group and 16.7 months (14.4–21.8) in the control group (HR 0.46, 95% CI 0.30–0.71; P =.0004). The most common adverse events during maintenance were thrombocytopenia, anaemia, hypertension, dyspnoea and bacterial infections. Conclusion: In summary, maintenance therapy with carfilzomib and dexamethasone after salvage ASCT prolonged TTP with 8 months. The maintenance treatment was in general well-tolerated with manageable toxicity.

Published
2022

21. Geographical and ecological analyses of multiple myeloma in Denmark: Identification of potential hotspot areas and impact of urbanisation.

Author

Bertelsen, Lise Dueholm, Børty Nielsen, Lars, Christensen, Heidi Søgaard, Bøgsted, Martin, Gregersen, Henrik, Pedersen, Robert Schou, Klostergaard, Anja, Schnack, Brian Iversen, Pedersen, Per Trøllund, Abildgaard, Niels, Hermansen, Emil, Vangsted, Annette Juul, and Severinsen, Marianne Tang

Subjects
MULTIPLE myeloma, URBANIZATION, ENVIRONMENTAL exposure, CITIES & towns, DISEASE clusters
Abstract

Background: The aetiology of multiple myeloma (MM) is unknown but various environmental exposures are suspected as risk factors. We present the first paper analysing the geographical distribution of MM in Denmark at the municipal level to investigate variations that could be explained by environmental exposures. Methods: Patients diagnosed with MM in Denmark during 2005–2020 were identified from nationwide registries and grouped into the 98 Danish municipalities based on residence. The age‐ and sex‐standardised incidence rate (SIR) of each municipality was compared to the national incidence in a funnel plot with 95% control limits. Differences in SIRs of rural, suburban, and urban areas were evaluated with incidence rate ratios. Results: In total, 5243 MM patients were included. Overall, we found a heterogeneous geographical distribution of MM and a potential hotspot in southern Denmark. This hotspot contains three municipalities with SIRs above the 95% control limit assuming considerably higher rate of MM compared to the national incidence rate. A significant higher SIR was found in rural areas compared to urban areas. Conclusion: The geographical distribution of MM in Denmark indicates that the risk of developing MM depends on place of residence probably due to environmental factors. [ABSTRACT FROM AUTHOR]

Published
2023
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22. Additional file 1 of Longitudinal minimal residual disease assessment in multiple myeloma patients in complete remission ��� results from the NMSG flow-MRD substudy within the EMN02/HO95 MM trial

Author

Schmitz, Alexander, Br��ndum, Rasmus Froberg, Johnsen, Hans Erik, Mellqvist, Ulf-Henrik, Waage, Anders, Gimsing, Peter, op Bruinink, Davine Hofste, van der Velden, Vincent, van der Holt, Bronno, Hansson, Markus, Andersen, Niels Frost, Fr��lund, Ulf Christian, Helleberg, Carsten, Schjesvold, Fredrik H., Ahlberg, Lucia, Gulbrandsen, Nina, Andreasson, Bjorn, Lauri, Birgitta, Haukas, Einar, B��dker, Julie St��ve, Roug, Anne Stidsholt, B��gsted, Martin, Severinsen, Marianne T., Gregersen, Henrik, Abildgaard, Niels, Sonneveld, Pieter, and Dybk��r, Karen

Subjects
Data_FILES
Abstract

Additional file 1.

Published
2022
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23. The Impact of the COVID-19 Pandemic on Quality of Life in Danish Patients with Multiple Myeloma; Results from an Ongoing Longitudinal National Survey

Author

Redder, Louise, primary, Möller, Sören, additional, Johnsen, Anna Thit, additional, Jarden, Mary, additional, lykkegaard Andersen, Christen, additional, Frederiksen, Henrik, additional, Gregersen, Henrik, additional, Klostergaard, Anja, additional, Steffensen, Morten Saaby, additional, Pedersen, Per Troellund, additional, Hinge, Maja, additional, Frederiksen, Mikael, additional, Helleberg, Carsten, additional, Abildgaard, Niels, additional, and Nielsen, Lene Kongsgaard, additional

Published
2021
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24. Effect of pamidronate 30 mg versus 90 mg on physical function in patients with newly diagnosed multiple myeloma (Nordic Myeloma Study Group): a double-blind, randomised controlled trial

Author

Gimsing, Peter, Carlson, Kristina, Turesson, Ingemar, Fayers, Peter, Waage, Anders, Vangsted, Annette, Mylin, Anne, Gluud, Christian, Juliusson, Gunnar, Gregersen, Henrik, Hjorth-Hansen, Henrik, Nesthus, Ingerid, Dahl, Inger Marie S, Westin, Jan, Nielsen, Johan Lanng, Knudsen, Lene Meldgaard, Ahlberg, Lucia, Hjorth, Martin, Abildgaard, Niels, Andersen, Niels Frost, Linder, Olle, and Wisløff, Finn

Published
2010
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25. Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma: A randomised phase 2 trial by the Nordic Myeloma Study Group

Author

Gregersen, Henrik, primary, Peceliunas, Valdas, additional, Remes, Kari, additional, Schjesvold, Fredrik, additional, Abildgaard, Niels, additional, Nahi, Hareth, additional, Andersen, Niels Frost, additional, Vangsted, Annette Juul, additional, Klausen, Tobias Wirenfeldt, additional, Helleberg, Carsten, additional, Carlson, Kristina, additional, Frølund, Ulf Christian, additional, Axelsson, Per, additional, Stromberg, Olga, additional, Blimark, Cecilie Hveding, additional, Crafoord, Jacob, additional, Tsykunova, Galina, additional, Eshoj, Henrik Rode, additional, Waage, Anders, additional, Hansson, Markus, additional, and Gulbrandsen, Nina, additional

Published
2021
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26. Direct costs of antineoplastic and supportive treatment for progressive multiple myeloma in a tax-based health system

Author

Brøndum, Rasmus F, primary, Vestergaard, Anne S, additional, Børty, Lars, additional, Vesteghem, Charles, additional, Rytter, Anne S, additional, Nielsen, Marlene M, additional, Severinsen, Marianne T, additional, Jensen, Paw, additional, Gregersen, Henrik, additional, El-Galaly, Tarec C, additional, Dybkær, Karen, additional, Ehlers, Lars H, additional, Bøgsted, Martin, additional, and Roug, Anne S, additional

Published
2021
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27. Quality of Life in Danish Patients with Multiple Myeloma during the COVID-19 Pandemic

Author

Redder, Louise, primary, Möller, Sören, additional, Johnsen, Anna Thit, additional, Jarden, Mary, additional, Andersen, Christen Lykkegaard, additional, Jensen, Bo Amdi, additional, Frederiksen, Henrik, additional, Gregersen, Henrik, additional, Klostergaard, Anja, additional, Steffensen, Morten Saaby, additional, Pedersen, Per Trøllund, additional, Hinge, Maja, additional, Frederiksen, Mikael, additional, Helleberg, Carsten, additional, Mylin, Anne Kærsgaard, additional, Abildgaard, Niels, additional, and Nielsen, Lene Kongsgaard, additional

Published
2021
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28. Outcome of treatment with carfilzomib before and after treatment with daratumumab in relapsed or refractory multiple myeloma patients

Author

Højholt, Karen Louise, primary, Gregersen, Henrik, additional, Szabo, Agoston Gyula, additional, Klausen, Tobias Wirenfeldt, additional, Levring, Mette Bøegh, additional, Preiss, Birgitte, additional, Helleberg, Carsten, additional, Breinholt, Marie Fredslund, additional, Hermansen, Emil, additional, Rahbek Gjerdrum, Lise Mette, additional, Bønløkke, Søren Thorgaard, additional, Nielsen, Katrine, additional, Kjeldsen, Eigil, additional, Iversen, Katrine Fladeland, additional, Teodorescu, Elena Manuela, additional, Kurt, Eva, additional, Strandholdt, Casper, additional, Andersen, Mette Klarskov, additional, and Vangsted, Annette Juul, additional

Published
2021
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29. Causes of early death in multiple myeloma patients who are ineligible for high-dose therapy with hematopoietic stem cell support: A study based on the nationwide Danish Myeloma Database

Author

Holmström, Morten O., Gimsing, Peter, Abildgaard, Niels, Andersen, Niels F., Helleberg, Carsten, Clausen, Niels Aage T., Klausen, Tobias W., Frederiksen, Mikael, Kristensen, Dan L., Larsen, Herdis, Pedersen, Per T., Andersen, Kristian Thidemann, Pedersen, Robert Schou, Jensen, Bo Amdi, Gregersen, Henrik, and Vangsted, Annette J.

Published
2015
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33. Dansk Myelomatose Database:Årsrapport 2020

Author

Hermansen, Emil, Kristensen, Ida Bruun, Gregersen, Henrik, Klostergaard, Anja, Pedersen, Robert Schou, Plesner, Torben, Pedersen, Per Trøllund, Helleberg, Carsten, Dravecká, Jana, Abildgaard, Niels, Silkjær, Trine, Vase, Maja Ølholm, Lund, Thomas, Preiss, Birgitte S., Møller, Hanne E, Nielsen, Lene Kongsgaard, Hansen, Charlotte Toftmann, Vangsted, Annette, Mylin, Anne, and Ehmsen, Boje

Published
2021

34. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma

Author

Sonneveld, Pieter Dimopoulos, Meletios A. Beksac, Meral van der Holt, Bronno Aquino, Sara Ludwig, Heinz Zweegman, Sonja and Zander, Thilo Zamagni, Elena Wester, Ruth Hajek, Roman and Pantani, Lucia Dozza, Luca Gay, Francesca Cafro, AnneMaria De Rosa, Luca Morelli, Annamaria Gregersen, Henrik and Gulbrandsen, Nina Cornelisse, Petra Troia, Rosella and Oliva, Stefania van de Velden, Vincent Wu, KaLung Ypma, Paula F. Bos, Gerard Levin, Mark-David Pour, Luca and Driessen, Christoph Broijl, Annemiek Croockewit, Alexandra and Minnema, Monique C. Waage, Anders Hveding, Cecilie van de Donk, Niels W. C. J. Offidani, Massimo Palumbo, Giuseppe A. and Spencer, Andrew Boccadoro, Mario Cavo, Michele

Abstract

PURPOSE To address the role of consolidation treatment for newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial. PATIENTS AND METHODS The EMN02/HOVON95 trial compared consolidation treatment with two cycles of bortezomib, lenalidomide, and dexamethasone (VRD) or no consolidation after induction and intensification therapy, followed by continuous lenalidomide maintenance. Primary study end point was progression-free survival (PFS). RESULTS Eight hundred seventy-eight eligible patients were randomly assigned to receive VRD consolidation (451 patients) or no consolidation (427 patients). At a median follow-up of 74.8 months, median PFS with adjustment for pretreatment was prolonged in patients randomly assigned to VRD consolidation (59.3 v 42.9 months, hazard ratio [HR] = 0.81; 95% CI, 0.68 to 0.96; P = .016). The PFS benefit was observed across most predefined subgroups, including revised International Staging System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3 stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI, 1.37 to 2.04) were significant adverse prognostic factors. The median duration of maintenance was 33 months (interquartile range 13-86 months). Response complete response (CR) after consolidation versus no consolidation before start of maintenance was 34% versus 18%, respectively (P < .001). Response >= CR on protocol including maintenance was 59% with consolidation and 46% without (P < .001). Minimal residual disease analysis by flow cytometry in a subgroup of 226 patients with CR or stringent complete response or very good partial response before start of maintenance demonstrated a 74% minimal residual disease-negativity rate in VRD-treated patients. Toxicity from VRD was acceptable and manageable. CONCLUSION Consolidation treatment with VRD followed by lenalidomide maintenance improves PFS and depth of response in newly diagnosed patients with multiple myeloma as compared to maintenance alone. (C) 2021 by American Society of Clinical Oncology

Published
2021

35. Validation of the UK myeloma research alliance risk profile, a new clinical prediction model for outcome in patients with newly diagnosed multiple myeloma not eligible for autologous stem cell transplantation; a population-based study from the Danish national multiple myeloma registry

Author

Redder, Louise, Klausen, Tobias W., Vangsted, Annette Juul, Gregersen, Henrik, Andersen, Niels F., Pedersen, Robert S., Szabo, Agoston G., Frederiksen, Mikael, Frølund, Ulf C., Helleberg, Carsten, Nielsen, Lene Kongsgaard, Pedersen, Per T., Salomo, Morten, Gimsing, Peter, Frederiksen, Henrik, Abildgaard, Niels, Redder, Louise, Klausen, Tobias W., Vangsted, Annette Juul, Gregersen, Henrik, Andersen, Niels F., Pedersen, Robert S., Szabo, Agoston G., Frederiksen, Mikael, Frølund, Ulf C., Helleberg, Carsten, Nielsen, Lene Kongsgaard, Pedersen, Per T., Salomo, Morten, Gimsing, Peter, Frederiksen, Henrik, and Abildgaard, Niels

Abstract

In 2019 the UK Myeloma Research Alliance introduced the Myeloma Risk Profile (MRP) for prediction of outcome in patients with newly diagnosed multiple myeloma (MM), ineligible for autologous stem cell transplantation. To validate the MRP in a population-based setting we performed a study of the entire cohort of transplant ineligible MM patients above 65 years in the Danish National MM Registry. Our data confirmed the value of the MRP. In a cohort of 1,377 patients, the MRP score separated patients into three distinct risk-groups with an observed hazard ratio of 2.91 for early death in high-risk versus low-risk patients.

Published
2021

36. Quality of Life in Danish Patients with Multiple Myeloma during the COVID-19 Pandemic

Author

Redder, Louise, Møller, Søren, Johnsen, Anna Thit, Jarden, Mary, Andersen, Christen Lykkegaard, Jensen, Bo Amdi, Frederiksen, Henrik, Gregersen, Henrik, Klostergaard, Anja, Steffensen, Morten Saaby, Pedersen, Per Trøllund, Hinge, Maja, Frederiksen, Mikael, Helleberg, Carsten, Mylin, Anne Kærsgaard, Abildgaard, Niels, Nielsen, Lene Kongsgaard, Redder, Louise, Møller, Søren, Johnsen, Anna Thit, Jarden, Mary, Andersen, Christen Lykkegaard, Jensen, Bo Amdi, Frederiksen, Henrik, Gregersen, Henrik, Klostergaard, Anja, Steffensen, Morten Saaby, Pedersen, Per Trøllund, Hinge, Maja, Frederiksen, Mikael, Helleberg, Carsten, Mylin, Anne Kærsgaard, Abildgaard, Niels, and Nielsen, Lene Kongsgaard

Published
2021

37. Can missing PRO data be handled appropriately by last observation carried forward (LOCF)?

Author

Nielsen, Lene, Mercieca-Bebber, Rebecca, Møller, Soren, Redder, Louise, Jarden, Mary, Andersen, Christian Lykkegaard, Frederiksen, Henrik, Gregersen, Henrik, Steffensen, Morten Saaby, Pedersen, Per Trollund, Hinge, Maja, Frederiksen, Mikael, Jensen, Bo Amdi, Helleberg, Carsten, Mylin, Anne Kærgaard, Abildgaard, Niels, King, Madeleine, Nielsen, Lene, Mercieca-Bebber, Rebecca, Møller, Soren, Redder, Louise, Jarden, Mary, Andersen, Christian Lykkegaard, Frederiksen, Henrik, Gregersen, Henrik, Steffensen, Morten Saaby, Pedersen, Per Trollund, Hinge, Maja, Frederiksen, Mikael, Jensen, Bo Amdi, Helleberg, Carsten, Mylin, Anne Kærgaard, Abildgaard, Niels, and King, Madeleine

Published
2021

38. Outcome of treatment with carfilzomib before and after treatment with daratumumab in relapsed or refractory multiple myeloma patients

Author

Højholt, Karen Louise, Gregersen, Henrik, Szabo, Agoston Gyula, Klausen, Tobias Wirenfeldt, Levring, Mette Bøegh, Preiss, Birgitte, Helleberg, Carsten, Breinholt, Marie Fredslund, Hermansen, Emil, Rahbek Gjerdrum, Lise Mette, Bønløkke, Søren Thorgaard, Nielsen, Katrine, Kjeldsen, Eigil, Iversen, Katrine Fladeland, Teodorescu, Elena Manuela, Kurt, Eva, Strandholdt, Casper, Andersen, Mette Klarskov, Vangsted, Annette Juul, Højholt, Karen Louise, Gregersen, Henrik, Szabo, Agoston Gyula, Klausen, Tobias Wirenfeldt, Levring, Mette Bøegh, Preiss, Birgitte, Helleberg, Carsten, Breinholt, Marie Fredslund, Hermansen, Emil, Rahbek Gjerdrum, Lise Mette, Bønløkke, Søren Thorgaard, Nielsen, Katrine, Kjeldsen, Eigil, Iversen, Katrine Fladeland, Teodorescu, Elena Manuela, Kurt, Eva, Strandholdt, Casper, Andersen, Mette Klarskov, and Vangsted, Annette Juul

Abstract

Real world evidence is important since most patients cannot be included in randomized clinical trials (RCTs). In a nationwide, cohort of relapsed/refractory multiple myeloma patients treated with daratumumab (N = 635), we retrospective studied patients treated with carfilzomib (N = 251). Data were collected by audit of medical records. We compared characteristics of patients treated with carfilzomib before daratumumab (Car-Da; N = 150) and after daratumumab (Da-Car; N = 101) with those not treated with carfilzomib (N = 384). Furthermore, we examined effectiveness and safety of carfilzomib. The group of patients treated with carfilzomib differed from patients not treated with carfilzomib in the following parameters: They were younger, more were treated up-front with high dose melphalan and autologous stem cell transplantation (HDM-ASCT)and had relapse within 18 months thereafter, and more had high-risk cytogenetic abnormalities (CA) and amplification 1q (amp1q). In patients treated with Car-Da, 30.3% had high-risk CA and 30.1% had amp1q and in Da-Car it was 43.3% and 41%, respectively. In the Car-Da cohort, 34.4% experienced early relapse after HDM-ASCT versus 47.4% in the Da-Car cohort. The percentage of patients with very good partial remission was higher in patients treated with Car-Da compared to Da-Car (31.7% vs. 17.4%). The median duration of treatment and time to next treatment (TNT) of Car-Da/Da-Car were 4.6/4.3 months and 7.1/4.3 months and only a trend toward superior TNT for Car-Da was found (p = 0.06). Toxicity of carfilzomib was the same as reported in RCT. A similar poor TNT of daratumumab was found when used before (5.6 months) or after carfilzomib (4.9 months). In this cohort of patients with sequential treatment with carfilzomib and daratumumab or vice versa, a high percentage of patients were high-risk by CA, amp1q, and early relapse after HDM-ASCT. Outcome of Car-DA and outcome of Da-Car were equally poor. These patients should be considered for

Published
2021

39. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Sonneveld, Pieter, Dimopoulos, Meletios A, Beksac, Meral, van der Holt, Bronno, Aquino, Sara, Ludwig, Heinz, Zweegman, Sonja, Zander, Thilo, Zamagni, Elena, Wester, Ruth, Hajek, Roman, Pantani, Lucia, Dozza, Luca, Gay, Francesca, Cafro, AnneMaria, De Rosa, Luca, Morelli, Annamaria, Gregersen, Henrik, Gulbrandsen, Nina, Cornelisse, Petra, Troia, Rosella, Oliva, Stefania, van de Velden, Vincent, Wu, KaLung, Ypma, Paula F, Bos, Gerard, Levin, Mark-David, Pour, Luca, Driessen, Christoph, Broijl, Annemiek, Croockewit, Alexandra, Minnema, Monique C, Waage, Anders, Hveding, Cecilie, van de Donk, Niels W C J, Offidani, Massimo, Palumbo, Giuseppe A, Spencer, Andrew, Boccadoro, Mario, Cavo, Michele, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Sonneveld, Pieter, Dimopoulos, Meletios A, Beksac, Meral, van der Holt, Bronno, Aquino, Sara, Ludwig, Heinz, Zweegman, Sonja, Zander, Thilo, Zamagni, Elena, Wester, Ruth, Hajek, Roman, Pantani, Lucia, Dozza, Luca, Gay, Francesca, Cafro, AnneMaria, De Rosa, Luca, Morelli, Annamaria, Gregersen, Henrik, Gulbrandsen, Nina, Cornelisse, Petra, Troia, Rosella, Oliva, Stefania, van de Velden, Vincent, Wu, KaLung, Ypma, Paula F, Bos, Gerard, Levin, Mark-David, Pour, Luca, Driessen, Christoph, Broijl, Annemiek, Croockewit, Alexandra, Minnema, Monique C, Waage, Anders, Hveding, Cecilie, van de Donk, Niels W C J, Offidani, Massimo, Palumbo, Giuseppe A, Spencer, Andrew, Boccadoro, Mario, and Cavo, Michele

Published
2021

43. Comorbidities in multiple myeloma and implications on survival: A population‐based study

Author

Sverrisdóttir, Ingigerður S., primary, Rögnvaldsson, Sölvi, additional, Thorsteinsdottir, Sigrún, additional, Gíslason, Gauti K., additional, Aspelund, Thor, additional, Turesson, Ingemar, additional, Björkholm, Magnus, additional, Gregersen, Henrik, additional, Hveding Blimark, Cecilie, additional, Landgren, Ola, additional, and Kristinsson, Sigurður Y., additional

Published
2021
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44. Monoklonal gammopati med ubestemt signifikans

Author

Hermansen, Niels Emil Ulrich, Silkjaer, Trine, Toftmann Hansen, Charlotte, Aagaard, Thomas Granum, and Gregersen, Henrik

Subjects
immune system diseases, hemic and lymphatic diseases, cardiovascular diseases
Abstract

This review summarises the work-up of patients with monoclonal gammopathy of undetermined significance (MGUS). In persons above 70 years of age, around 5% have MGUS, a premalignant state with a monoclonal plasma immunoglobulin or light chain (M protein) in blood and/or urine. Continuous follow-up is recommended due to a risk of malignant progression of around 1% per year. Immunoglobulin M MGUS primarily progresses to Waldenström's macroglobulinaemia, whereas non-immunoglobulin M MGUS typically progresses to multiple myeloma or amyloid light-chain amyloidosis. Treatment is unnecessary unless in rare cases of severe non-malignant complications. Screening is not advised.

Published
2020

48. Validation of the UK myeloma research alliance risk profile, a new clinical prediction model for outcome in patients with newly diagnosed multiple myeloma not eligible for autologous stem cell transplantation; a population‐based study from the Danish national multiple myeloma registry

Author

Redder, Louise, primary, Klausen, Tobias W., additional, Vangsted, Annette Juul, additional, Gregersen, Henrik, additional, Andersen, Niels F., additional, Pedersen, Robert S., additional, Szabo, Agoston G., additional, Frederiksen, Mikael, additional, Frølund, Ulf C., additional, Helleberg, Carsten, additional, Nielsen, Lene Kongsgaard, additional, Pedersen, Per T., additional, Salomo, Morten, additional, Gimsing, Peter, additional, Frederiksen, Henrik, additional, and Abildgaard, Niels, additional

Published
2020
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50. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

Author

Attal, Michel, primary, Richardson, Paul G, additional, Rajkumar, S Vincent, additional, San-Miguel, Jesus, additional, Beksac, Meral, additional, Spicka, Ivan, additional, Leleu, Xavier, additional, Schjesvold, Fredrik, additional, Moreau, Philippe, additional, Dimopoulos, Meletios A, additional, Huang, Jeffrey Shang-Yi, additional, Minarik, Jiri, additional, Cavo, Michele, additional, Prince, H Miles, additional, Macé, Sandrine, additional, Corzo, Kathryn P, additional, Campana, Frank, additional, Le-Guennec, Solenn, additional, Dubin, Franck, additional, Anderson, Kenneth C, additional, Attal, Michel, additional, Richardson, Paul G., additional, Rajkumar, Vincent, additional, Dimopoulos, Meletios A., additional, Prince, H. Miles, additional, Corzo, Kathryn P., additional, Anderson, Kenneth C., additional, Harrison, Simon, additional, Janowski, Wojt, additional, Kerridge, Ian, additional, Spencer, Andrew, additional, Delforge, Michel, additional, Fostier, Karel, additional, Vlummens, Philip, additional, Wu, Ka Lung, additional, Leblanc, Richard, additional, Pavic, Michel, additional, Sebag, Michael, additional, Hajek, Roman, additional, Maisnar, Vladimir, additional, Pour, Ludek, additional, Gregersen, Henrik, additional, Benbouker, Lotfi, additional, Caillot, Denis, additional, Escoffre-Barbe, Martine, additional, Facon, Thierry, additional, Frenzel, Laurent, additional, Hulin, Cyrille, additional, Karlin, Lionel, additional, Kolb, Brigitte, additional, Pegourie, Brigitte, additional, Perrot, Aurore, additional, Tiab, Mourad, additional, Vincent, Laure, additional, Niederwieser, Dietger, additional, Anagnostopoulos, Achilles, additional, Delimpasi, Sosana, additional, Kyrtsonis, Marie-Christine, additional, Symeonidis, Anargyros, additional, Illes, Arpad, additional, Mikala, Gabor, additional, Nagy, Zsolt, additional, Bringen, Sara, additional, Corradini, Paolo, additional, Fabio, Ciceri, additional, Lemoli, Roberto, additional, Liberati, Anna, additional, Nozzoli, Chiara, additional, Zambello, Renato, additional, Iida, Shinsuke, additional, Ikeda, Takashi, additional, Iyama, Satoshi, additional, Matsumoto, Morio, additional, Shimazaki, Chihiro, additional, Sunami, Kazutaka, additional, Suzuki, Kenshi, additional, Uchiyama, Michihiro, additional, Koh, Youngil, additional, Kim, Kihyun, additional, Lee, Jae Hoon, additional, Min, Chang-Ki, additional, Blacklock, Hillary, additional, Goodman, Hugh, additional, Neylon, Annette, additional, Simpson, David, additional, Grosicki, Sebastian, additional, Jurczyszyn, Artur, additional, Walter-Croneck, Adam, additional, Warzocha, Krzysztof, additional, Araujo, Luis, additional, Moreira, Claudia, additional, Doronin, Vadim, additional, Mendeleeva, Larisa, additional, Vorobyev, Vladimir, additional, Vranovsky, Andrej, additional, Alegre, Adrian, additional, Gironella, Mercedes, additional, Gonzalez Perez, Marta Sonia, additional, Montes, Carmen, additional, Ocio, Enrique, additional, Rodriguez, Paula, additional, Hardling, Mats, additional, Lauri, Birgitta, additional, Wang, Ming-Chung, additional, Yeh, Su-Peng, additional, Arat, Mutlu, additional, Demirkan, Fatih, additional, Gulbas, Zafer, additional, Besisik, Sevgi Kalayoglu, additional, Karadogan, Ihsan, additional, Tuglular, Tulin, additional, Unal, Ali, additional, Vural, Filiz, additional, Sive, Jonathan, additional, Streetly, Matthew, additional, Yong, Kwee, additional, and Tache, Jason, additional

Published
2019
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