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
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...
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MDPI AG
2024-02-01
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| author | Anu Partanen Anders Waage Valdas Peceliunas Fredrik Schjesvold Pekka Anttila Marjaana Säily Katarina Uttervall Mervi Putkonen Kristina Carlson Einar Haukas Marja Sankelo Damian Szatkowski Markus Hansson Anu Marttila Ronald Svensson Per Axelsson Birgitta Lauri Maija Mikkola Conny Karlsson Johanna Abelsson Erik Ahlstrand Anu Sikiö Monika Klimkowska Reda Matuzeviciene Mona Hoysaeter Fenstad Sorella Ilveskero Tarja-Terttu Pelliniemi Hareth Nahi Raija Silvennoinen |
| author_facet | Anu Partanen Anders Waage Valdas Peceliunas Fredrik Schjesvold Pekka Anttila Marjaana Säily Katarina Uttervall Mervi Putkonen Kristina Carlson Einar Haukas Marja Sankelo Damian Szatkowski Markus Hansson Anu Marttila Ronald Svensson Per Axelsson Birgitta Lauri Maija Mikkola Conny Karlsson Johanna Abelsson Erik Ahlstrand Anu Sikiö Monika Klimkowska Reda Matuzeviciene Mona Hoysaeter Fenstad Sorella Ilveskero Tarja-Terttu Pelliniemi Hareth Nahi Raija Silvennoinen |
| author_sort | Anu Partanen |
| collection | DOAJ |
| description | 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<sup>−5</sup> 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<sup>−5</sup> 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 (<i>p</i> = 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10<sup>−5</sup>. Altogether 95% of the patients with sustained MRD <10<sup>−5</sup>, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (<i>p</i> < 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients. |
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| spelling | doaj.art-87bacac1ff7d4b10b2063f2b679a492e2024-03-12T16:41:15ZengMDPI AGCancers2072-66942024-02-01165102410.3390/cancers16051024Ixazomib, Lenalidomide, and Dexamethasone (IRD) Treatment with Cytogenetic Risk-Based Maintenance in Transplant-Eligible Myeloma: A Phase 2 Multicenter Study by the Nordic Myeloma Study GroupAnu Partanen0Anders Waage1Valdas Peceliunas2Fredrik Schjesvold3Pekka Anttila4Marjaana Säily5Katarina Uttervall6Mervi Putkonen7Kristina Carlson8Einar Haukas9Marja Sankelo10Damian Szatkowski11Markus Hansson12Anu Marttila13Ronald Svensson14Per Axelsson15Birgitta Lauri16Maija Mikkola17Conny Karlsson18Johanna Abelsson19Erik Ahlstrand20Anu Sikiö21Monika Klimkowska22Reda Matuzeviciene23Mona Hoysaeter Fenstad24Sorella Ilveskero25Tarja-Terttu Pelliniemi26Hareth Nahi27Raija Silvennoinen28Department of Medicine, Kuopio University Hospital, 70210 Kuopio, FinlandDepartment of Hematology, St. Olavs Hospital, 7030 Trondheim, NorwayHematology, Oncology and Transfusion Medicine Center, Vilnius University Hospital, 08661 Vilnius, LithuaniaOslo Myeloma Center, Department of Hematology, Oslo University Hospital, 0450 Oslo, NorwayHelsinki University Hospital Cancer Center Hematology, University of Helsinki, 00029 Helsinki, FinlandHematology-Oncology Unit, Oulu University Hospital Hematology, 90220 Oulu, FinlandMedical Unit Hematology, Karolinska University Hospital, 171 64 Solna, SwedenDepartment of Medicine, Turku University Hospital, 20521 Turku, FinlandDepartment of Hematology, Uppsala University Hospital, 751 85 Uppsala, SwedenStavanger University Hospital, 4011 Stavanger, NorwayHematology Unit, Department of Internal Medicine, Tampere University Hospital Hematology, 33520 Tampere, FinlandDepartment of Oncology, Hematology and Palliative Care, Foerde Central Hospital, 6812 Foerde, NorwayDepartment of Hematology, Skåne University Hospital, 222 42 Lund, SwedenDepartment of Medicine, Kymenlaakso Central Hospital, 48210 Kotka, FinlandDepartment of Hematology, Linköping University Hospital, 581 85 Linköping, SwedenDepartment of Haematology, Helsingborg Hospital, 252 23 Helsingborg, SwedenDepartment of Hematology, Sunderby Hospital, 971 80 Luleå, SwedenDepartment of Medicine, Päijät-Häme Central Hospital, 15850 Lahti, FinlandDepartment of Haematology, Halland Hospital, 302 33 Halmstad, SwedenDepartment of Hematology, Uddevalla Hospital, 451 53 Uddevalla, SwedenDepartment of Medicine, Örebro University Hospital, 701 85 Örebro, SwedenDepartment of Medicine, Central Finland Central Hospital, 40620 Jyväskylä, FinlandDepartment of Clinical Pathology and Cytology, Karolinska University Hospital, 141 86 Stockholm, SwedenDepartment of Physiology, Biochemistry, Microbiology and Laboratory Medicine, Biomedical Sciences Institute, Vilnius University Hospital and Vilnius University Faculty of Medicine, 03101 Vilnius, LithuaniaDepartment of Immunology and Transfusion Medicine, St. Olavs Hospital, 7030 Trondheim, NorwayClinical Chemistry, Helsinki University Hospital, University of Helsinki, 00014 Helsinki, FinlandFimlab Laboratories Ltd., 33520 Tampere, FinlandHematology Centre, Karolinska University Hospital Huddinge, 141 57 Stockholm, SwedenHelsinki University Hospital Cancer Center Hematology, University of Helsinki, 00029 Helsinki, FinlandScarce 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<sup>−5</sup> 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<sup>−5</sup> 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 (<i>p</i> = 0.395) and 36% (43/120) were CR or better, of which 42% (18/43) had undetectable flow MRD <10<sup>−5</sup>. Altogether 95% of the patients with sustained MRD <10<sup>−5</sup>, 82% of the patients who turned MRD-positive, and 61% of those with positive MRD had no disease progression at two years on maintenance (<i>p</i> < 0.001). To conclude, prolonged maintenance with all-oral ixazomib plus lenalidomide might improve PFS in HR patients.https://www.mdpi.com/2072-6694/16/5/1024multiple myelomaixazomibautologous stem cell transplantationmeasurable residual diseaseprogression-free survivalmaintenance |
| spellingShingle | Anu Partanen Anders Waage Valdas Peceliunas Fredrik Schjesvold Pekka Anttila Marjaana Säily Katarina Uttervall Mervi Putkonen Kristina Carlson Einar Haukas Marja Sankelo Damian Szatkowski Markus Hansson Anu Marttila Ronald Svensson Per Axelsson Birgitta Lauri Maija Mikkola Conny Karlsson Johanna Abelsson Erik Ahlstrand Anu Sikiö Monika Klimkowska Reda Matuzeviciene Mona Hoysaeter Fenstad Sorella Ilveskero Tarja-Terttu Pelliniemi Hareth Nahi Raija Silvennoinen 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 Cancers multiple myeloma ixazomib autologous stem cell transplantation measurable residual disease progression-free survival maintenance |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | multiple myeloma ixazomib autologous stem cell transplantation measurable residual disease progression-free survival maintenance |
| url | https://www.mdpi.com/2072-6694/16/5/1024 |
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