Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma : A randomised phase 2 trial by the Nordic Myeloma Study Group
© 2021 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:108 |
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| Enthalten in: |
European journal of haematology - 108(2022), 1 vom: 05. Jan., Seite 34-44 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Gregersen, Henrik [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 14.03.2022 Date Revised 31.07.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/ejh.13709 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM330782398 |
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| 100 | 1 | |a Gregersen, Henrik |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Carfilzomib and dexamethasone maintenance following salvage ASCT in multiple myeloma |b A randomised phase 2 trial by the Nordic Myeloma Study Group |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 14.03.2022 | ||
| 500 | |a Date Revised 31.07.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2021 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd. | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a carfilzomib | |
| 650 | 4 | |a induction chemotherapy | |
| 650 | 4 | |a maintenance chemotherapy | |
| 650 | 4 | |a multiple myeloma | |
| 650 | 4 | |a salvage therapy | |
| 650 | 7 | |a Biomarkers, Tumor |2 NLM | |
| 650 | 7 | |a Oligopeptides |2 NLM | |
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| 650 | 7 | |a Dexamethasone |2 NLM | |
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| 700 | 1 | |a Peceliunas, Valdas |e verfasserin |4 aut | |
| 700 | 1 | |a Remes, Kari |e verfasserin |4 aut | |
| 700 | 1 | |a Schjesvold, Fredrik |e verfasserin |4 aut | |
| 700 | 1 | |a Abildgaard, Niels |e verfasserin |4 aut | |
| 700 | 1 | |a Nahi, Hareth |e verfasserin |4 aut | |
| 700 | 1 | |a Andersen, Niels Frost |e verfasserin |4 aut | |
| 700 | 1 | |a Vangsted, Annette Juul |e verfasserin |4 aut | |
| 700 | 1 | |a Klausen, Tobias Wirenfeldt |e verfasserin |4 aut | |
| 700 | 1 | |a Helleberg, Carsten |e verfasserin |4 aut | |
| 700 | 1 | |a Carlson, Kristina |e verfasserin |4 aut | |
| 700 | 1 | |a Frølund, Ulf Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Axelsson, Per |e verfasserin |4 aut | |
| 700 | 1 | |a Stromberg, Olga |e verfasserin |4 aut | |
| 700 | 1 | |a Blimark, Cecilie Hveding |e verfasserin |4 aut | |
| 700 | 1 | |a Crafoord, Jacob |e verfasserin |4 aut | |
| 700 | 1 | |a Tsykunova, Galina |e verfasserin |4 aut | |
| 700 | 1 | |a Eshoj, Henrik Rode |e verfasserin |4 aut | |
| 700 | 1 | |a Waage, Anders |e verfasserin |4 aut | |
| 700 | 1 | |a Hansson, Markus |e verfasserin |4 aut | |
| 700 | 1 | |a Gulbrandsen, Nina |e verfasserin |4 aut | |
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