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

CASSIOPEIA part 1 demonstrated superior depth of response and prolonged progression-free survival with daratumumab in combination with bortezomib, thalidomide, and dexamethasone (D-VTd) versus bortezomib, thalidomide, and dexamethasone (VTd) alone as an induction and consolidation regimen in transpl...

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Veröffentlicht in:The lancet oncology 2024-08, Vol.25 (8), p.1003-1014
Hauptverfasser: Moreau, Philippe, Hulin, Cyrille, Perrot, Aurore, Arnulf, Bertrand, Belhadj, Karim, Benboubker, Lotfi, Zweegman, Sonja, Caillon, Hélène, Caillot, Denis, Avet-Loiseau, Hervé, Delforge, Michel, Dejoie, Thomas, Facon, Thierry, Sonntag, Cécile, Fontan, Jean, Mohty, Mohamad, Jie, Kon-Siong, Karlin, Lionel, Kuhnowski, Frédérique, Lambert, Jérôme, Leleu, Xavier, Macro, Margaret, Orsini-Piocelle, Frédérique, Roussel, Murielle, Schiano de Colella, Jean Marc, van de Donk, Niels WCJ, Wuillème, Soraya, Broijl, Annemiek, Touzeau, Cyrille, Tiab, Mourad, Marolleau, Jean-Pierre, Meuleman, Nathalie, Vekemans, Marie-Christiane, Westerman, Matthijs, Klein, Saskia K, Levin, Mark-David, Offner, Fritz, Escoffre-Barbe, Martine, Eveillard, Jean-Richard, Garidi, Réda, Hua, Winnie, Wang, Jianping, Tuozzo, Alba, de Boer, Carla, Rowe, Melissa, Vanquickelberghe, Veronique, Carson, Robin, Vermeulen, Jessica, Corre, Jill, Sonneveld, Pieter
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Zusammenfassung:CASSIOPEIA part 1 demonstrated superior depth of response and prolonged progression-free survival with daratumumab in combination with bortezomib, thalidomide, and dexamethasone (D-VTd) versus bortezomib, thalidomide, and dexamethasone (VTd) alone as an induction and consolidation regimen in transplant-eligible patients newly diagnosed with myeloma. In CASSIOPEIA part 2, daratumumab maintenance significantly improved progression-free survival and increased minimal residual disease (MRD)-negativity rates versus observation. Here, we report long-term study outcomes of CASSIOPEIA. CASSIOPEIA was a two-part, open-label, phase 3 trial of patients done at 111 European academic and community-based centres. Eligible patients were aged 18–65 years with transplant-eligible newly diagnosed myeloma and an Eastern Cooperative Oncology Group performance status of 0–2. In part 1, patients were randomly assigned (1:1) to pre-transplant induction and post-transplant consolidation with D-VTd or VTd. Patients who completed consolidation and had a partial response or better were re-randomised (1:1) to intravenous daratumumab maintenance (16 mg/kg every 8 weeks) or observation for 2 years or less. An interactive web-based system was used for both randomisations, and randomisation was balanced using permuted blocks of four. Stratification factors for the first randomisation (induction and consolidation phase) were site affiliation, International Staging System disease stage, and cytogenetic risk status. Stratification factors for the second randomisation (maintenance phase) were induction treatment and depth of response in the induction and consolidation phase. The primary endpoint for the induction and consolidation phase was the proportion of patients who achieved a stringent complete response after consolidation; results for this endpoint remain unchanged from those reported previously. The primary endpoint for the maintenance phase was progression-free survival from second randomisation. Efficacy evaluations in the induction and consolidation phase were done on the intention-to-treat population, which included all patients who underwent first randomisation, and efficacy analyses in the maintenance phase were done in the maintenance-specific intention-to-treat population, which included all patients who were randomly assigned at the second randomisation. This analysis represents the final data cutoff at the end of the study. The trial is registered with ClinicalTrials.gov, N
ISSN:1470-2045
1474-5488
1474-5488
DOI:10.1016/S1470-2045(24)00282-1