A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
NCT ID: NCT02541383
Last Updated: 2025-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1085 participants
INTERVENTIONAL
2015-09-30
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
Arm B Part 1
Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Arm A Part 2
Observation
No interventions assigned to this group
Arm B Part 2
daratumumab
Daratumumab
Daratumumab 16mg/kg every 8 weeks for 2 years
Interventions
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Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab
Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
Daratumumab
Daratumumab 16mg/kg every 8 weeks for 2 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a confirmed diagnosis and eligible for high dose chemotherapy and autologous stem cell transplantation, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2
Exclusion Criteria
* Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma
* Prior or concurrent exposure to systemic therapy or SCT (Stem Cell Transplantation) for any plasma cell dyscrasia, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment, or received an investigational drug or used an invasive investigational medical device within 4 weeks before Cycle 1, Day 1
* history of malignancy (other than Multiple Myeloma) within 10 years before the date of randomization, except for the following if treated and not active: basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of breast, or International Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
* known chronic obstructive pulmonary disease (COPD) or moderate to severe asthma
* any concurrent medical or psychiatric condition or disease (eg, autoimmune disease, active systemic disease, myelodysplasia) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
18 Years
65 Years
ALL
No
Sponsors
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HOVON - Dutch Haemato-Oncology Association
OTHER
Janssen Research & Development, LLC
INDUSTRY
Intergroupe Francophone du Myelome
NETWORK
Responsible Party
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Principal Investigators
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Philippe Moreau, Pr
Role: PRINCIPAL_INVESTIGATOR
CHU Nantes, France
Locations
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BE-Antwerp-ZNA Stuivenberg
Antwerp, , Belgium
AZ St Jan Brugge Oostende AV
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
UCL Saint-Luc
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
GHDC
Charleroi, , Belgium
UZ Gent
Ghent, , Belgium
CH Jolimont
La Louvière, , Belgium
University Hospital Leuven
Leuven, , Belgium
Domaine Universitaire du Sart Tilman
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
AZ Turnhout
Turnhout, , Belgium
UCL Mont-Godinne
Yvoir, , Belgium
CHU Amiens Sud
Amiens, , France
CHRU-Hôpital du Bocage
Angers, , France
Centre Hospitalier d'Argenteuil Victor Dupouy
Argenteuil, , France
Centre Hospitalier H.Duffaut
Avignon, , France
Centre hospitalier de la Côte Basque
Bayonne, , France
Hôpital Jean Minjoz
Besançon, , France
Hôpital Avicenne
Bobigny, , France
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, , France
Hôpital de Fleyriat
Bourg-en-Bresse, , France
CHRU Brest - Hôpital A. Morvan
Brest, , France
CHU Caen - Côte de Nacre
Caen, , France
Clinique du Parc
Castelnau-le-Lez, , France
CH René Dubos
Cergy-Pontoise, , France
Hôpital Privé Sévigné
Cesson-Sévigné, , France
Centre Hospitalier William Morey
Chalon-sur-Saône, , France
CH Chambéry
Chambéry, , France
Hôpital d'Instruction des Armées Percy
Clamart, , France
CHU d'Estaing
Clermont-Ferrand, , France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, , France
CHU Henri Mondor
Créteil, , France
CHRU Dijon - Hôpital des Enfants
Dijon, , France
Centre Hospitalier Général
Dunkirk, , France
CHRU Hôpital A. Michallon
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
CHV André Mignot - Université de Versailles
Le Chesnay, , France
CH de Chartres - Hôpital Louis Pasteur
Le Coudray, , France
Centre Hospitalier
Le Mans, , France
Clinique Victor Hugo
Le Mans, , France
CHRU Hôpital Claude Huriez
Lille, , France
GH de l'Institut Catholique Saint Vincent
Lille, , France
Centre Hospitalier Universitaire (CHU) de Limoges
Limoges, , France
Hôpital du Scorff
Lorient, , France
Centre Léon Bérard
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
CH Meaux
Meaux, , France
Hôpital de Mercy (CHR Metz-Thionville)
Metz, , France
Hopital Saint Eloi - CHU Montpellier
Montpellier, , France
Hôpital E. Muller
Mulhouse, , France
Centre Catherine de Sienne
Nantes, , France
CHRU Hôtel Dieu
Nantes, , France
Clinique de l'Archet
Nice, , France
CHU Carémeau
Nîmes, , France
CH La Source
Orléans, , France
CHU Hôpital Saint Antoine
Paris, , France
Hôpital Cochin
Paris, , France
Hôpital Necker
Paris, , France
Hôpital Saint Louis
Paris, , France
Institut Curie
Paris, , France
La Pitié
Paris, , France
CH Saint Jean
Perpignan, , France
CHRU - Hôpital du Haut Lévêque - Centre François Magendie
Pessac, , France
Centre Hospitalier de Perigueux
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Poitiers - Pôle régional de Cancérologie
Poitiers, , France
Ch Annecy Genevois
Pringy, , France
Hôpital Robert Debré
Reims, , France
CHRU Hôpital de Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Hospitalier Yves Le Foll
Saint-Brieuc, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Centre Hospitalier
Saint-Quentin, , France
CHU Strasbourg
Strasbourg, , France
Strasbourg Oncologie Médicale
Strasbourg, , France
Pôle IUCT Oncopole CHU
Toulouse, , France
CHRU Hôpital Bretonneau
Tours, , France
CHRU Hôpitaux de Brabois
Vandœuvre-lès-Nancy, , France
CHBA
Vannes, , France
MC Alkmaar
Alkmaar, , Netherlands
Meander MC
Amersfoort, , Netherlands
AMC
Amsterdam, , Netherlands
OLVG
Amsterdam, , Netherlands
Vumc
Amsterdam, , Netherlands
Ziekenhuis Rijnstate
Arnhem, , Netherlands
Amphia Hospital Breda
Breda, , Netherlands
RdGG
Delft, , Netherlands
Deventer zkh
Deventer, , Netherlands
Albert Schweitzer zkh
Dordrecht, , Netherlands
Maxima MC
Eindhoven, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
UMCG
Groningen, , Netherlands
Atrium MC/Zuyderland MC
Heerlen, , Netherlands
Tergooiziekenhuizen, location Hilversum
Hilversum, , Netherlands
Spaarne Gasthuis
Hoofddorp, , Netherlands
MC Leeuwarden
Leeuwarden, , Netherlands
LUMC
Leiden, , Netherlands
MUMC
Maastricht, , Netherlands
Antonius zkh
Nieuwegein, , Netherlands
Radboudumc
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Maasstad Ziekenhuis
Rotterdam, , Netherlands
Haga zkh
The Hague, , Netherlands
Elisabeth zkh
Tilburg, , Netherlands
UMCU
Utrecht, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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HO131
Identifier Type: OTHER
Identifier Source: secondary_id
54767414MMY3006
Identifier Type: OTHER
Identifier Source: secondary_id
2014-004781-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IFM 2015-01
Identifier Type: -
Identifier Source: org_study_id
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