A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

Summary

The purpose of this study is to evaluate if the addition of daratumumab to Bortezomib, Thalidomide and Dexamethasone will increase the stringent complete response rate after consolidation therapy and increase the progression free survival after daratumumab maintenance therapy in transplant eligible participants with previously untreated Multiple Myeloma.

Timeline

Start

2015-09

Primary completion

2020-08-27

Completion

2023-09-01

Publications

• Results Moreau P, Attal M, Hulin C, Arnulf B, Belhadj K, Benboubker L, Bene MC, Broijl A, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Garderet L, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Lenain P, Macro M, Mathiot C, Orsini-Piocelle F, Perrot A, Stoppa AM, van de Donk NW, Wuilleme S, Zweegman S, Kolb B, Touzeau C, Roussel M, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Fermand JP, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Zhuang S, Chiu C, Pei L, de Boer C, Smith E, Deraedt W, Kampfenkel T, Schecter J, Vermeulen J, Avet-Loiseau H, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, open-label, phase 3 study. Lancet. 2019 Jul 6;394(10192):29-38. doi: 10.1016/S0140-6736(19)31240-1. Epub 2019 Jun 3.
• Results Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Bene MC, Zweegman S, Caillon H, Caillot D, Corre J, Delforge M, Dejoie T, Doyen C, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Stoppa AM, van de Donk NWCJ, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Ahmadi T, Krevvata M, Zhang K, de Boer C, Vara S, Kampfenkel T, Vanquickelberghe V, Vermeulen J, Avet-Loiseau H, Sonneveld P. Maintenance with daratumumab or observation following treatment with bortezomib, thalidomide, and dexamethasone with or without daratumumab and autologous stem-cell transplant in patients with newly diagnosed multiple myeloma (CASSIOPEIA): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Oct;22(10):1378-1390. doi: 10.1016/S1470-2045(21)00428-9. Epub 2021 Sep 13.
• Results Moreau P, Hulin C, Perrot A, Arnulf B, Belhadj K, Benboubker L, Zweegman S, Caillon H, Caillot D, Avet-Loiseau H, Delforge M, Dejoie T, Facon T, Sonntag C, Fontan J, Mohty M, Jie KS, Karlin L, Kuhnowski F, Lambert J, Leleu X, Macro M, Orsini-Piocelle F, Roussel M, Schiano de Colella JM, van de Donk NW, Wuilleme S, Broijl A, Touzeau C, Tiab M, Marolleau JP, Meuleman N, Vekemans MC, Westerman M, Klein SK, Levin MD, Offner F, Escoffre-Barbe M, Eveillard JR, Garidi R, Hua W, Wang J, Tuozzo A, de Boer C, Rowe M, Vanquickelberghe V, Carson R, Vermeulen J, Corre J, Sonneveld P; Intergroupe Francophone du Myelome, the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and the CASSIOPEIA Investigators. Bortezomib, thalidomide, and dexamethasone with or without daratumumab and followed by daratumumab maintenance or observation in transplant-eligible newly diagnosed multiple myeloma: long-term follow-up of the CASSIOPEIA randomised controlled phase 3 trial. Lancet Oncol. 2024 Aug;25(8):1003-1014. doi: 10.1016/S1470-2045(24)00282-1. Epub 2024 Jun 15.
• Jamet B, Ahrari S, Zweegman S, Perrot A, Hulin C, Caillot D, Facon T, Leleu X, Belhadj K, Itti E, Karlin L, Bailly C, Levin MD, Minnema MC, Bodet-Milin C, de Keizer B, Corre J, Sonneveld P, Mateus D, Moreau P, Touzeau C, Kraeber-Bodere F, Carlier T. FDG-PET medullary total tumor volume highlights high-risk patients with newly diagnosed multiple myeloma in CASSIOPEIA trial. Blood Adv. 2026 Jun 9;10(11):3787-3798. doi: 10.1182/bloodadvances.2025019465.
• Kraeber-Bodere F, Jamet B, Zweegman S, Perrot A, Hulin C, Caillot D, Facon T, Leleu X, Belhadj K, Itti E, Karlin L, Bailly C, Levin MD, Minnema MC, Bodet-Milin C, de Keizer B, Corre J, Sonneveld P, Moreau P, Carlier T, Touzeau C. Prognostic value of premaintenance FDG PET/CT response in patients with newly diagnosed myeloma from the CASSIOPEIA trial. Blood. 2025 Dec 18;146(25):3050-3058. doi: 10.1182/blood.2025030084.
• Corre J, Vincent L, Moreau P, Hebraud B, Hulin C, Bene MC, Broijl A, Caillot D, Delforge M, Dejoie T, Facon T, Lambert J, Leleu X, Macro M, Perrot A, Zweegman S, Filleron T, Cabarrou B, van de Donk NWCJ, Maheo S, Hua W, Wang J, Krevvata M, Vanquickelberghe V, de Boer C, Tuozzo A, Borgsten F, Rowe M, Carson R, Wuilleme S, Sonneveld P. Daratumumab-bortezomib-thalidomide-dexamethasone for newly diagnosed myeloma: CASSIOPEIA minimal residual disease results. Blood. 2025 Aug 7;146(6):679-692. doi: 10.1182/blood.2024027620.
• Kraeber-Bodere F, Zweegman S, Perrot A, Hulin C, Caillot D, Facon T, Leleu X, Belhadj K, Itti E, Karlin L, Bailly C, Levin MD, Minnema MC, Jamet B, Bodet-Milin C, De Keizer B, Bene MC, Avet-Loiseau H, Sonneveld P, Pei L, Rigat F, De Boer C, Vermeulen J, Kampfenkel T, Lambert J, Moreau P. Prognostic value of positron emission tomography/computed tomography in transplant-eligible newly diagnosed multiple myeloma patients from CASSIOPEIA: the CASSIOPET study. Haematologica. 2023 Feb 1;108(2):621-626. doi: 10.3324/haematol.2021.280051. No abstract available.
• Alberge JB, Kraeber-Bodere F, Jamet B, Touzeau C, Caillon H, Wuilleme S, Bene MC, Kampfenkel T, Sonneveld P, van Duin M, Avet-Loiseau H, Corre J, Magrangeas F, Carlier T, Bodet-Milin C, Cherel M, Moreau P, Minvielle S, Bailly C. Molecular Signature of 18F-FDG PET Biomarkers in Newly Diagnosed Multiple Myeloma Patients: A Genome-Wide Transcriptome Analysis from the CASSIOPET Study. J Nucl Med. 2022 Jul;63(7):1008-1013. doi: 10.2967/jnumed.121.262884. Epub 2022 Jan 27.
• Hulin C, Offner F, Moreau P, Roussel M, Belhadj K, Benboubker L, Caillot D, Facon T, Garderet L, Kuhnowski F, Stoppa AM, Kolb B, Tiab M, Jie KS, Westerman M, Lambert J, Pei L, Vanquickelberghe V, De Boer C, Vermeulen J, Kampfenkel T, Sonneveld P, Van de Donk NWCJ. Stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone in the phase 3 CASSIOPEIA study. Haematologica. 2021 Aug 1;106(8):2257-2260. doi: 10.3324/haematol.2020.261842. No abstract available.
• Roussel M, Moreau P, Hebraud B, Laribi K, Jaccard A, Dib M, Slama B, Dorvaux V, Royer B, Frenzel L, Zweegman S, Klein SK, Broijl A, Jie KS, Wang J, Vanquickelberghe V, de Boer C, Kampfenkel T, Gries KS, Fastenau J, Sonneveld P. Bortezomib, thalidomide, and dexamethasone with or without daratumumab for transplantation-eligible patients with newly diagnosed multiple myeloma (CASSIOPEIA): health-related quality of life outcomes of a randomised, open-label, phase 3 trial. Lancet Haematol. 2020 Dec;7(12):e874-e883. doi: 10.1016/S2352-3026(20)30356-2.

Drugs

Indications