A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
Cassiopeia
Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma
4 other identifiers
interventional
1,085
3 countries
107
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 multiple-myeloma
Started Sep 2015
Typical duration for phase_3 multiple-myeloma
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedResults Posted
Study results publicly available
April 13, 2025
CompletedApril 13, 2025
March 1, 2025
5 years
June 24, 2015
November 5, 2024
March 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Post-Consolidation Stringent Complete Response (sCR) Rate
Post-consolidation sCR rate is defined as the percentage of ITT subjects who achieved or maintained sCR status within 30 days of Day 100 post Autologous Stem Cell Transplant (ASCT). The sCR status is assessed using the computerized algorithm according to IMWG response criteria, and must be achieved on or prior to start of subsequent therapies. Subjects must not die or progress by Day 100 post ASCT. According to the IMWG consensus recommendations for multiple myeloma treatment response criteria from 2006, the stringent complete response (sCR) was defined by a negative immunofixation on the serum and urine, and a disappearance of any soft tissue plasmacytomas, and \< 5% plasma cells in bone marrow, plus normal free-light chain ratio and the absence of clonal bone marrow plasma cells by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry.
At day 100 post Autologous Stem Cell Transplant (ASCT), up to 114 days post ASCT
Progression Free Survival (PFS) Post Completion of Maintenance Therapy
Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the completion of Maintenance therapy.
From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).
Secondary Outcomes (1)
Progression Free Survival (PFS) From First Randomization up to the End of the Study
From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study
Study Arms (4)
Arm A Part 1
OTHERBortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)
Arm B Part 1
EXPERIMENTALBortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) plus daratumumab
Arm A Part 2
NO INTERVENTIONObservation
Arm B Part 2
EXPERIMENTALdaratumumab
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Diagnosis of previously untreated multiple myeloma (MM)
- 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
You may not qualify if:
- previous treatment for Multiple Myeloma
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Intergroupe Francophone du Myelomelead
- HOVON - Dutch Haemato-Oncology Associationcollaborator
- Janssen Research & Development, LLCcollaborator
Study Sites (107)
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, 71100, 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, 44202, 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, 1201 DA, 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, 2545 CH, Netherlands
Elisabeth zkh
Tilburg, Netherlands
UMCU
Utrecht, Netherlands
Isala Klinieken
Zwolle, Netherlands
Related Publications (9)
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.
PMID: 31171419RESULTMoreau 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.
PMID: 34529931RESULTMoreau 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.
PMID: 38889735RESULTKraeber-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.
PMID: 40991848DERIVEDCorre 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.
PMID: 40127397DERIVEDKraeber-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.
PMID: 36263839DERIVEDAlberge 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.
PMID: 35086897DERIVEDHulin 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.
PMID: 33657786DERIVEDRoussel 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.
PMID: 33242444DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Executive Officier
- Organization
- Intergroupe Francophone du Myélome
Study Officials
- PRINCIPAL INVESTIGATOR
Philippe Moreau, Pr
CHU Nantes, France
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2015
First Posted
September 4, 2015
Study Start
September 1, 2015
Primary Completion
August 27, 2020
Study Completion
September 1, 2023
Last Updated
April 13, 2025
Results First Posted
April 13, 2025
Record last verified: 2025-03