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2. Effectiveness and infectious complications of BCMA T-cell engagers in treating multiple myeloma: Real-world evidence from Sweden

Author

Uttervall, Katarina, Tätting, Love, Lemonakis, Konstantinos, Majd, Mousa, Crafoord, Jacob, Olsson, Mikael, Mellqvist, Ulf-Henrik, Hansson, Markus, Nahi, Hareth, Uttervall, Katarina, Tätting, Love, Lemonakis, Konstantinos, Majd, Mousa, Crafoord, Jacob, Olsson, Mikael, Mellqvist, Ulf-Henrik, Hansson, Markus, and Nahi, Hareth

Abstract

Background: Multiple myeloma (MM), an incurable disease characterized by frequent relapses and a need for multiple treatments, often progresses to a relapse/refractory status resistant to all available drugs and drug classes. Bispecific antibodies, specifically BCMA T-cell engagers, have emerged as effective treatments for MM, demonstrating impressive efficacy. However, these treatments can adversely affect the immune system, increasing vulnerability to infections. Methods/Results: This study evaluated the efficacy and safety of BCMA T-cell engagers in 58 Swedish patients with poor MM prognosis. The patients exhibited a 69% overall response rate, with 69% survival and 60% progression-free survival at 15 months. Conclusions: Despite the risk of infectious complications, the prognosis of MM patients can be significantly improved with vigilant monitoring and proactive management of infections. This real-world data highlight the potential of BCMA T-cell engagers in treating MM, emphasizing the need for careful patient monitoring to mitigate infection risks., Funding Agencies|Cancerfonden; [4-2528/2019]

Published
2024
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3. Ixazomib, Lenalidomide, and Dexamethasone (IRD) Treatment with Cytogenetic Risk-Based Maintenance in Transplant-Eligible Myeloma: A Phase 2 Multicenter Study by the Nordic Myeloma Study Group

Author

Partanen, Anu, Waage, Anders, Peceliunas, Valdas, Schjesvold, Fredrik, Anttila, Pekka, Saeily, Marjaana, Uttervall, Katarina, Putkonen, Mervi, Carlson, Kristina, Haukas, Einar, Sankelo, Marja, Szatkowski, Damian, Hansson, Markus, Marttila, Anu, Svensson, Ronald, Axelsson, Per, Lauri, Birgitta, Mikkola, Maija, Karlsson, Conny, Abelsson, Johanna, Ahlstrand, Erik, Sikioe, Anu, Klimkowska, Monika, Matuzeviciene, Reda, Fenstad, Mona Hoysaeter, Ilveskero, Sorella, Pelliniemi, Tarja-Terttu, Nahi, Hareth, Silvennoinen, Raija, Partanen, Anu, Waage, Anders, Peceliunas, Valdas, Schjesvold, Fredrik, Anttila, Pekka, Saeily, Marjaana, Uttervall, Katarina, Putkonen, Mervi, Carlson, Kristina, Haukas, Einar, Sankelo, Marja, Szatkowski, Damian, Hansson, Markus, Marttila, Anu, Svensson, Ronald, Axelsson, Per, Lauri, Birgitta, Mikkola, Maija, Karlsson, Conny, Abelsson, Johanna, Ahlstrand, Erik, Sikioe, Anu, Klimkowska, Monika, Matuzeviciene, Reda, Fenstad, Mona Hoysaeter, Ilveskero, Sorella, Pelliniemi, Tarja-Terttu, Nahi, Hareth, and Silvennoinen, Raija

Abstract

Scarce data exist on double maintenance in transplant-eligible high-risk (HR) newly diagnosed multiple myeloma (NDMM) patients. This prospective phase 2 study enrolled 120 transplant-eligible NDMM patients. The treatment consisted of four cycles of ixazomib-lenalidomide-dexamethasone (IRD) induction plus autologous stem cell transplantation followed by IRD consolidation and cytogenetic risk-based maintenance therapy with lenalidomide + ixazomib (IR) for HR patients and lenalidomide (R) alone for NHR patients. The main endpoint of the study was undetectable minimal residual disease (MRD) with sensitivity of <10-5 by flow cytometry at any time, and other endpoints were progression-free survival (PFS) and overall survival (OS). We present the preplanned analysis after the last patient has been two years on maintenance. At any time during protocol treatment, 28% (34/120) had MRD < 10-5 at least once. At two years on maintenance, 66% of the patients in the HR group and 76% in the NHR group were progression-free (p = 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10-5. Altogether 95% of the patients with sustained MRD <10-5, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (p < 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients., Funding Agencies|BMS

Published
2024
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4. Ixazomib, Lenalidomide, and Dexamethasone (IRD) Treatment with Cytogenetic Risk-Based Maintenance in Transplant-Eligible Myeloma: A Phase 2 Multicenter Study by the Nordic Myeloma Study Group

Author

Partanen, Anu, primary, Waage, Anders, additional, Peceliunas, Valdas, additional, Schjesvold, Fredrik, additional, Anttila, Pekka, additional, Säily, Marjaana, additional, Uttervall, Katarina, additional, Putkonen, Mervi, additional, Carlson, Kristina, additional, Haukas, Einar, additional, Sankelo, Marja, additional, Szatkowski, Damian, additional, Hansson, Markus, additional, Marttila, Anu, additional, Svensson, Ronald, additional, Axelsson, Per, additional, Lauri, Birgitta, additional, Mikkola, Maija, additional, Karlsson, Conny, additional, Abelsson, Johanna, additional, Ahlstrand, Erik, additional, Sikiö, Anu, additional, Klimkowska, Monika, additional, Matuzeviciene, Reda, additional, Fenstad, Mona Hoysaeter, additional, Ilveskero, Sorella, additional, Pelliniemi, Tarja-Terttu, additional, Nahi, Hareth, additional, and Silvennoinen, Raija, additional

Published
2024
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6. P881: DURABILITY OF RESPONSES WITH BIWEEKLY DOSING OF TECLISTAMAB IN PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA ACHIEVING A CLINICAL RESPONSE IN THE MAJESTEC-1 STUDY

Author

Bhutani, Manisha, primary, Garfall, Alfred, additional, Uttervall, Katarina, additional, Usmani, Saad Z, additional, Karlin, Lionel, additional, Benboubker, Lotfi, additional, Nahi, Hareth, additional, San Miguel, Jesús, additional, Trancucci, Danielle, additional, Qi, Keqin, additional, Stephenson, Tara, additional, Perales-Puchalt, Alfredo, additional, Chastain, Katherine, additional, and Chari, Ajai, additional

Published
2023
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7. P898: A PROSPECTIVE PHASE 2 STUDY TO ASSESS MINIMAL RESIDUAL DISEASE AFTER IXAZOMIB, LENALIDOMIDE, DEXAMETHASONE (IRD) TREATMENT FOR NEWLY DIAGNOSED TRANSPLANT ELIGIBLE MULTIPLE MYELOMA PATIENTS

Author

Silvennoinen, Raija, primary, Partanen, Anu, additional, Waage, Anders, additional, Pečeliūnas, Valdas, additional, Schjesvold, Fredrik, additional, Anttila, Pekka, additional, Uttervall, Katarina, additional, Säily, Marjaana, additional, Putkonen, Mervi, additional, Carlson, Kristina, additional, Haukas, Einar, additional, Sankelo, Marja, additional, Szatkowski, Damian, additional, Hansson, Markus, additional, Marttila, Anu, additional, Axelsson, Per, additional, Svensson, Ronald, additional, Lauri, Birgitta, additional, Mikkola, Maija, additional, Karlsson, Conny, additional, Abelsson, Johanna, additional, Ahlstrand, Erik, additional, Sikiö, Anu, additional, Klimkowska, Monika, additional, Matuzeviciene, Reda, additional, Hoyseter Fenstad, Mona, additional, Ilveskero, Sorella, additional, and Nahi, Hareth, additional

Published
2023
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8. P911: EVALUATION OF PROPHYLACTIC TOCILIZUMAB (TOCI) FOR THE REDUCTION OF CYTOKINE RELEASE SYNDROME (CRS) TO INFORM THE MANAGEMENT OF PATIENTS (PTS) TREATED WITH TECLISTAMAB IN MAJESTEC-1

Author

van de Donk, Niels W.C.J., primary, Garfall, Alfred, additional, Benboubker, Lotfi, additional, Uttervall, Katarina, additional, Groen, Kaz, additional, Rosiñol Dachs, Laura, additional, Hodin, Caroline, additional, Stephenson, Tara, additional, Trancucci, Danielle, additional, Perales-Puchalt, Alfredo, additional, Kobos, Rachel, additional, Banerjee, Arnob, additional, and Mateos, Maria-Victoria, additional

Published
2023
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9. Minimal residual disease status is the prognostic determinant following high-dose treatment for patients with multiple myeloma

Author

Nahi, Hareth, Afram, Gabriel, Uttervall, Katarina, Lockmer, Sandra, Tätting, Love, Gahrton, Gosta, Kashif, Muhammad, Alici, Evren, Stromberg, Olga, Klimkowska, Monika, Lund, Johan, Nahi, Hareth, Afram, Gabriel, Uttervall, Katarina, Lockmer, Sandra, Tätting, Love, Gahrton, Gosta, Kashif, Muhammad, Alici, Evren, Stromberg, Olga, Klimkowska, Monika, and Lund, Johan

Abstract

Background: The presence of minimal residual disease (MRD+) following autologous stem cell transplantation (ASCT) in multiple myeloma represents a poor prognostic factor for progression-free survival (PFS) and overall survival (OS).Methods: At our department, we recommend lenalidomide maintenance for patients who are MRD+ after ASCT, while MRD-negative (MRD-) patients, after information about the national guidelines, were not advised to follow this regimen.Results: Out of the total 228 patients, 175 received ASCT following first-line induction (MRD- 92 (53%), MRD+ 83 (47%), at 2 months post-ASCT), while 53 underwent ASCT after second-line treatment (MRD- 27 (51%), MRD+ 26 (49%), at the same time point). Comparatively, MRD- patients who did not receive maintenance demonstrated better OS than MRD+ patients who received upfront ASCT and maintenance treatment (96% vs. 86%, p = 0.030, at 3 years). However, nonsignificant difference was found in PFS (76% vs. 62%, at 3 years). Furthermore, second-line ASCT, MRD- non-maintained patients exhibited significantly better PFS than MRD+ (71% vs. 27%, p > 0.001, at 3 years). However, OS was better but nonsignificant (96% vs. 76%, at 3 years). Fluorescence in situ hybridization (FISH) analysis was performed on 141 out of the 228 patients. Of these, 85 (60%) patients were deemed standard risk (SR), and 56 (40%) were classified as high risk (HR). In the SR cohort, MRD- patients exhibited better PFS and OS than MRD+ patients (71% vs. 59% and 100% vs. 85%, respectively). In the HR cohort, the MRD- patients showed superior PFS but similar OS compared to MRD+ patients (66% vs. 42% and 81% vs. 80%, respectively).Conclusions: Our results indicate that being MRD- is a more crucial prognostic factor for the 3-year PFS and OS than the presence of high-risk cytogenetic markers or undergoing maintenance treatment. The latter appears insufficient, particularly for MRD+ patients following ASCT in the second-line setting, suggesting that th, Funding Agencies|We would like to extend our gratitude to all patients and their families who participated in this study. Their willingness to contribute has been crucial for the continuation of our research. We would also like to acknowledge the invaluable work of our col

Published
2023
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11. Response to Caravita di Toritto and Rago

Author

Chaireti, Roza, primary, Uttervall, Katarina, additional, Luong, Vincent, additional, Lund, Johan, additional, Kashif, Muhammad, additional, Gahrton, Gösta, additional, Alici, Evren, additional, Nahi, Hareth, additional, and Afram, Gabriel, additional

Published
2022
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13. P-222: A prospective phase 2 study to assess minimal residual disease after ixazomib plus lenalidomide plus dexamethasone (IRd) treatment for newly diagnosed transplant eligible multiple myeloma patients

Author

Silvennoinen, Raija, primary, Waage, Anders, additional, Peceliunas, Valdas, additional, Schjesvold, Fredrik, additional, Anttila, Pekka, additional, Uttervall, Katarina, additional, Säily, Marjaana, additional, Putkonen, Mervi, additional, Carlson, Kristina, additional, Haukas, Einar, additional, Sankelo, Marja, additional, Partanen, Anu, additional, Szatkowski, Damian, additional, Hansson, Markus, additional, Marttila, Anu, additional, Svensson, Ronald, additional, Axelsson, Per, additional, Lauri, Birgitta, additional, Mikkola, Maija, additional, Karlsson, Conny, additional, Abelsson, Johanna, additional, Ahlstrand, Erik, additional, Sikiö, Anu, additional, and Nahi, Hareth, additional

Published
2022
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14. MM-344 Longer-Term Follow-up of Patients Receiving Prophylactic Tocilizumab for the Reduction of Cytokine Release Syndrome (CRS) in the Phase 1/2 MajesTEC-1 Study of Teclistamab in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

van de Donk, Niels WCJ, Garfall, Alfred L, Benboubker, Lotfi, Uttervall, Katarina, Groen, Kaz, Rosiñol, Laura, Matous, Jeffrey V, Vishwamitra, Deeksha, Hodin, Caroline, Stephenson, Tara, Qi, Keqin, Zuppa, Athena, Chastain, Katherine, and Mateos, María-Victoria

Published
2024
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15. Longer-Term Follow-up of Patients Receiving Prophylactic Tocilizumab for the Reduction of Cytokine Release Syndrome (CRS) in the Phase 1/2 MajesTEC-1 Study of Teclistamab in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

van de Donk, Niels WCJ, Garfall, Alfred L, Benboubker, Lotfi, Uttervall, Katarina, Groen, Kaz, Rosiñol, Laura, Matous, Jeffrey V, Vishwamitra, Deeksha, Hodin, Caroline, Stephenson, Tara, Qi, Keqin, Zuppa, Athena, Chastain, Katherine, and Mateos, María-Victoria

Published
2024
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17. Synergistic effects of low-dose belantamab mafodotin in combination with a gamma-secretase inhibitor (nirogacestat) in patients with relapsed/refractory multiple myeloma (RRMM): DREAMM-5 study.

Author

Lonial, Sagar, primary, Grosicki, Sebastian, additional, Hus, Marek, additional, Song, Kevin W., additional, Facon, Thierry, additional, Callander, Natalie Scott, additional, Ribrag, Vincent, additional, Uttervall, Katarina, additional, Quach, Hang, additional, Vorobyev, Vladimir I., additional, Min, Chang Ki, additional, Cheng, Shinta, additional, Smith, L. Mary, additional, Yu, Jing, additional, Collingwood, Therese, additional, Holkova, Beata, additional, Kremer, Brandon, additional, Gupta, Ira, additional, Richardson, Paul G., additional, and Minnema, Monique C., additional

Published
2022
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18. DREAMM-5 Study: Investigating the Synergetic Effects of Belantamab Mafodotin Plus Inducible T-Cell Co-Stimulator Agonist (aICOS) Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma

Author

Callander, Natalie S., primary, Ribrag, Vincent, additional, Richardson, Paul G., additional, Nooka, Ajay K., additional, Song, Kevin, additional, Uttervall, Katarina, additional, Minnema, Monique C., additional, Weisel, Katja, additional, Quach, Hang, additional, Min, Chang-Ki, additional, Ballas, Marc S., additional, Li, Xiaofang, additional, Ratia, Nirav, additional, Kaisermann, Morrys, additional, Holkova, Beata, additional, and Trudel, Suzanne, additional

Published
2021
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19. P-212: DREAMM-5 platform trial: Belantamab mafodotin (belamaf; GSK2857916) in combination with five different novel agents in patients with relapsed/refractory multiple myeloma (RRMM)

Author

Richardson, Paul G., primary, Trudel, Suzanne, additional, Callander, Natalie S., additional, Nooka, Ajay, additional, Song, Kevin, additional, Uttervall, Katarina, additional, Minnema, Monique C., additional, Rodríguez-Otero, Paula, additional, Struemper, Herbert, additional, Yeakey, Anne, additional, de Oca, Rocio Montes, additional, Smith, L. Mary, additional, Jackson, Nicola, additional, Kaisermann, Morrys, additional, Im, Ellie, additional, Basile, Frank G., additional, Ahlers, Christoph M., additional, Holkova, Beata, additional, Gupta, Ira, additional, Kremer, Brandon E., additional, and Quach, Hang, additional

Published
2021
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20. Conditioning with melphalan 200 mg/m2 and subsequent ASCT improves progression‐free and overall survival in elderly myeloma patients compared to standard of care.

Author

Afram, Gabriel, Chaireti, Roza, Uttervall, Katarina, Luong, Vincent, Lund, Johan, Kashif, Muhammad, Gahrton, Gösta, Alici, Evren, and Nahi, Hareth

Subjects
OLDER patients, PROGRESSION-free survival, OVERALL survival, STEM cell transplantation, MELPHALAN
Abstract

Objectives: Despite the effectiveness of newer drugs for the treatment of multiple myeloma (MM), the outcomes are further improved by subsequent autologous stem cell transplantation (ASCT). Data on effectiveness in older patients are limited. We compared outcomes in patients aged 65–75 years depending on whether they were treated with ASCT or not and compared those to outcomes in patients <65 years. Methods: This was a retrospective, single‐center study. We compared progression‐free survival (PFS) and overall survival (OS) for all MM patients below and above the age of 65 years treated ± ASCT at the Karolinska University Hospital between 2010 and 2020. PFS and OS were calculated by the Kaplan–Meier method. Variables affecting PFS and OS were evaluated using Cox regression model. Results: Both PFS and OS were improved in the group 65–75 years treated +ASCT compared to those treated pharmacologically (p = 0.008 and p < 0.001, respectively). There were no significant differences between patients <65 years and those 65–75 years treated with ASCT. Conclusion: The findings indicate that even patients >65 years should be evaluated as candidates for ASCT. An individualized approach supported by a frailty/geriatric assessment score could assist clinicians to select the appropriate treatment for each patient. [ABSTRACT FROM AUTHOR]

Published
2022
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23. Improved survival in myeloma patients: starting to close in on the gap between elderly patients and a matched normal population

Author

Liwing, Johan, Uttervall, Katarina, Lund, Johan, Aldrin, Anders, Blimark, Cecilie, Carlson, Kristina, Enestig, Jon, Flogegård, Max, Forsberg, Karin, Gruber, Astrid, Kviele, Helene Haglöf, Johansson, Peter, Lauri, Birgitta, Mellqvist, Ulf-Henrik, Swedin, Agneta, Svensson, Magnus, Näsman, Per, Alici, Evren, Gahrton, Gösta, Aschan, Johan, and Nahi, Hareth

Published
2014
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25. Low dose venetoclax as a single agent treatment of plasma cell malignancies harboring t(11;14)

Author

Nahi, Hareth, primary, Kashif, Muhammad, additional, Klimkowska, Monika, additional, Karvouni, Maria, additional, Wallblom, Ann, additional, Gran, Charlotte, additional, Hauenstein, Julia, additional, Frengen, Nicolai, additional, Gustafsson, Charlotte, additional, Afram, Gabriel, additional, Uttervall, Katarina, additional, Lund, Johan, additional, Månsson, Robert, additional, Wagner, Arnika K., additional, and Alici, Evren, additional

Published
2021
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26. Improved survival in multiple Myeloma patients undergoing autologous stem cell transplantation is entirely in the standard cytogenetic risk groups

Author

Afram, Gabriel, primary, Susek, Katharina Helene, additional, Uttervall, Katarina, additional, Wersäll, Johanna Dehlsen, additional, Wagner, Arnika Kathleen, additional, Luong, Vincent, additional, Lund, Johan, additional, Gahrton, Gösta, additional, Alici, Evren, additional, and Nahi, Hareth, additional

Published
2021
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30. Response to Caravita di Toritto and Rago.

Author

Chaireti, Roza, Uttervall, Katarina, Luong, Vincent, Lund, Johan, Kashif, Muhammad, Gahrton, Gösta, Alici, Evren, Nahi, Hareth, and Afram, Gabriel

Subjects
*STEM cell transplantation, *AUTOGRAFTS, *MULTIPLE myeloma
Abstract

Dear Editor, We have with interest read the response by Dr. Caravita di Toritto and Dr. Rago to our recently published article entitled "Conditioning with melphalan (Mel) 200 mg/m SP 2 sp and subsequent autologous stem cell transplantation (ASCT) improves progression-free survival (PFS) and overall survival (OS) in elderly multiple myeloma (MM) patients compared to standard of care". 9 Badros A, Barlogie B, Siegel E. Results of autologous stem cell transplant in multiple myeloma patients with renal failure. Autologous stem cell transplantation in multiple myeloma patients over 70 years: a GIMEMA Lazio working group experience in a retrospective case-control study. [Extracted from the article]

Published
2023
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31. Biological markers and treatment as prognostic factors in multiple myeloma

Author

Uttervall, Katarina and Uttervall, Katarina

Abstract

Multiple myeloma (MM) is an incurable disease with an increasing number of treatment options. The introduction of what are called novel drugs (bortezomib, lenalidomide and thalidomide) was an important step. These treatments have been well studied in clinical trials that involve selected patient groups and that focus on a specific treatment in a specific line of treatment. However, there is scarce information on the survival as a function of the entire treatment sequence. We wanted to clarify the effect of these treatments in a real-life setting. Furthermore, there are several well-known prognostic factors for MM, but the impact of those factors on survival in the era of novel treatment is not fully understood. In this thesis we aimed to: 1) understand in which order the treatments should be given, 2) define factors affecting prognosis, 3) increase the knowledge of cytogenetic abnormalities and their influence on prognosis and choice of treatment. In Paper I, we retrospectively analysed the outcome in high-dose treated (HDT) patients. The patients were divided according to induction therapy. 142 patients had received conventional chemotherapy with either vincristine, doxorubicin, dexamethasone (VAD) or cyclophosphamide, betamethasone (CyBet) and 94 patients had received bortezomib, cyclophosphamide, betamethasone (VCB). We found that the VCB patients had a quicker and better response than the VAD/CyBet group as well as a longer time to progression. In Paper II, we investigated 1 638 consecutive MM patients and compared their survival with that of a sex- and age-matched normal population. The use of novel agents as upfront treatment in non-HDT patients resulted in a significantly longer overall survival (OS) compared to those who received conventional chemotherapy. The OS was further improved by using novel agents in both first and second line of treatment and for these patients the OS approached the survival in the matched normal population. Paper III focused on MM

Published
2015

36. Is Multiple Myeloma a Chronic Disease? : A Population Based Study Comparing 1843 Patients to a Matched Swedish Population

Author

Nahi, Hareth, Liwing, Johan, Aldrin, Anders, Andreasson, Johan, Blimark, Cecilie, Carlson, Kristina, Enestig, Jon, Flogegard, Max, Forsberg, Karin, Gruber, Astrid, Johansson, Peter, Kviele, Helene, Lauri, Birgitta, Mellqvist, Ulf-Henrik, Näsman, Per, Swedin, Agneta, Svensson, Magnus, Uttervall, Katarina, Aschan, Johan, Nahi, Hareth, Liwing, Johan, Aldrin, Anders, Andreasson, Johan, Blimark, Cecilie, Carlson, Kristina, Enestig, Jon, Flogegard, Max, Forsberg, Karin, Gruber, Astrid, Johansson, Peter, Kviele, Helene, Lauri, Birgitta, Mellqvist, Ulf-Henrik, Näsman, Per, Swedin, Agneta, Svensson, Magnus, Uttervall, Katarina, and Aschan, Johan

Abstract

QC 20130311

Published
2012
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38. Improved survival in myeloma patients: starting to close in on the gap between elderly patients and a matched normal population

Author

Liwing, Johan, primary, Uttervall, Katarina, additional, Lund, Johan, additional, Aldrin, Anders, additional, Blimark, Cecilie, additional, Carlson, Kristina, additional, Enestig, Jon, additional, Flogegård, Max, additional, Forsberg, Karin, additional, Gruber, Astrid, additional, Haglöf Kviele, Helene, additional, Johansson, Peter, additional, Lauri, Birgitta, additional, Mellqvist, Ulf-Henrik, additional, Swedin, Agneta, additional, Svensson, Magnus, additional, Näsman, Per, additional, Alici, Evren, additional, Gahrton, Gösta, additional, Aschan, Johan, additional, and Nahi, Hareth, additional

Published
2013
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41. Is Multiple Myeloma a Chronic Disease? A Population Based Study Comparing 1843 Patients to a Matched Swedish Population.

Author

Nahi, Hareth, primary, Liwing, Johan, additional, Aldrin, Anders, additional, Andreasson, Johan, additional, Blimark, Cecilie, additional, Carlson, Kristina, additional, Enestig, Jon, additional, Flogegård, Max, additional, Forsberg, Karin, additional, Gruber, Astrid, additional, Johansson, Peter, additional, Kviele, Helene, additional, Lauri, Birgitta, additional, Mellqvist, Ulf-Henrik, additional, Näsman, Per, additional, Swedin, Agneta, additional, Svensson, Magnus, additional, Uttervall, Katarina, additional, and Aschan, Johan, additional

Published
2012
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43. Daratumumab or Active Monitoring for High-Risk Smoldering Multiple Myeloma.

Author

Dimopoulos MA, Voorhees PM, Schjesvold F, Cohen YC, Hungria V, Sandhu I, Lindsay J, Baker RI, Suzuki K, Kosugi H, Levin MD, Beksac M, Stockerl-Goldstein K, Oriol A, Mikala G, Garate G, Theunissen K, Spicka I, Mylin AK, Bringhen S, Uttervall K, Pula B, Medvedova E, Cowan AJ, Moreau P, Mateos MV, Goldschmidt H, Ahmadi T, Sha L, Cortoos A, Katz EG, Rousseau E, Li L, Dennis RM, Carson R, and Rajkumar SV

Abstract

Background: Daratumumab, an anti-CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma. Data are needed regarding the use of daratumumab for high-risk smoldering multiple myeloma, a precursor disease of active multiple myeloma for which no treatments have been approved., Methods: In this phase 3 trial, we randomly assigned patients with high-risk smoldering multiple myeloma to receive either subcutaneous daratumumab monotherapy or active monitoring. Treatment was continued for 39 cycles, for 36 months, or until confirmation of disease progression, whichever occurred first. The primary end point was progression-free survival; progression to active multiple myeloma was assessed by an independent review committee in accordance with International Myeloma Working Group diagnostic criteria., Results: Among the 390 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group. With a median follow-up of 65.2 months, the risk of disease progression or death was 51% lower with daratumumab than with active monitoring (hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.67; P<0.001). Progression-free survival at 5 years was 63.1% with daratumumab and 40.8% with active monitoring. A total of 15 patients (7.7%) in the daratumumab group and 26 patients (13.3%) in the active-monitoring group died (hazard ratio, 0.52; 95% CI, 0.27 to 0.98). Overall survival at 5 years was 93.0% with daratumumab and 86.9% with active monitoring. The most common grade 3 or 4 adverse event was hypertension, which occurred in 5.7% and 4.6% of the patients in the daratumumab group and the active-monitoring group, respectively. Adverse events led to treatment discontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were identified., Conclusions: Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2024
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