Spots Global Cancer Trial Database for A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
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Trial Identification
Brief Title: A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma
Official Title: 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
Study ID: NCT02541383
Conditions
Study Description
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.
Detailed Description: This is a randomized, open-label (identity of assigned treatment will be known to participants and study staff), 2-arm (2 treatment groups), multicenter study of daratumumab in participants diagnosed with previously untreated Multiple Myeloma who are eligible for high dose chemotherapy and autologous stem cell transplantation (transplantation of own bone marrow). Participants will be randomized (assigned by chance) to one of 2 treatment groups to either receive daratumumab plus bortezomib, thalidomide and dexamethasone or bortezomib, thalidomide and dexamethasone for induction (before transplantation) and consolidation (after transplantation) treatment. All responders will then be re-randomized (assigned by chance) to one of 2 treatment groups to receive maintenance treatment with daratumumab only or observation (no treatment). The study will include a 28-Day Screening Phase, a Treatment Phase of 6 treatment cycles (each cycle is 4 weeks in duration for total period of 30 weeks), and a Follow up Phase of 2 years. The total duration for each participant in the study will be approximately 138 weeks. The end of the study will occur approximately 5 years after the last participant is randomized in the second phase of the study. Disease assessments will be performed every 4 weeks in the first phase of the study and then every 8 weeks in the second phase of the study. Safety will be monitored throughout the study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
BE-Antwerp-ZNA Stuivenberg, Antwerp, , Belgium
AZ St Jan Brugge Oostende AV, Brugge, , Belgium
Institut Jules Bordet, Bruxelles, , Belgium
UCL Saint-Luc, Bruxelles, , Belgium
UZ Brussel, Bruxelles, , Belgium
GHDC, Charleroi, , Belgium
UZ Gent, Gent, , Belgium
CH Jolimont, La Louviere, , Belgium
University Hospital Leuven, Leuven, , Belgium
Domaine Universitaire du Sart Tilman, Liege, , Belgium
AZ Delta, Roeselare, , Belgium
AZ Turnhout, Turnhout, , Belgium
UCL Mont-Godinne, Yvoir, , Belgium
CHU Amiens Sud, AMIENS Cedex 1, , France
CHRU-H么pital du Bocage, ANGERS Cedex 1, , France
Centre Hospitalier d'Argenteuil Victor Dupouy, Argenteuil, , France
Centre Hospitalier H.Duffaut, AVIGNON Cedex 9, , France
Centre hospitalier de la C么te Basque, Bayonne, , France
H么pital Jean Minjoz, BESANCON Cedex, , France
H么pital Avicenne, BOBIGNY Cedex, , France
Polyclinique Bordeaux Nord Acquitaine, Bordeaux, , France
H么pital de Fleyriat, BOURG EN BRESSE Cedex, , France
CHRU Brest - H么pital A. Morvan, BREST Cedex, , France
CHU Caen - C么te de Nacre, CAEN Cedex, , France
Clinique du Parc, Castelnau-le-lez, , France
CH Ren茅 Dubos, Cergy-pontoise, , France
H么pital Priv茅 S茅vign茅, Cesson-S茅vign茅, , France
Centre Hospitalier William Morey, Chalon-sur-Sa么ne, , France
CH Chamb茅ry, Chambery, , France
H么pital d'Instruction des Arm茅es Percy, CLAMART Cedex, , France
CHU d'Estaing, Clermont-ferrand, , France
Centre Hospitalier Sud Francilien, CORBEIL-ESSONNES Cedex, , France
CHU Henri Mondor, Creteil, , France
CHRU Dijon - H么pital des Enfants, Dijon, , France
Centre Hospitalier G茅n茅ral, Dunkerque, , France
CHRU H么pital A. Michallon, GRENOBLE Cedex 9, , France
CHD Vend茅e, LA ROCHE SUR YON Cedex 9, , France
CHV Andr茅 Mignot - Universit茅 de Versailles, Le Chesnay, , France
CH de Chartres - H么pital Louis Pasteur, Le Coudray, , France
Centre Hospitalier, LE MANS Cedex, , France
Clinique Victor Hugo, Le Mans, , France
CHRU H么pital Claude Huriez, LILLE Cedex, , France
GH de l'Institut Catholique Saint Vincent, Lille, , France
Centre Hospitalier Universitaire (CHU) de Limoges, Limoges, , France
H么pital du Scorff, Lorient, , France
Centre L茅on B茅rard, Lyon, , France
Institut Paoli Calmettes, MARSEILLE Cedex, , France
CH Meaux, Meaux, , France
H么pital de Mercy (CHR Metz-Thionville), METZ Cedex 1, , France
Hopital Saint Eloi - CHU Montpellier, MONTPELLIER Cedex, , France
H么pital E. Muller, Mulhouse, , France
CHRU H么tel Dieu, Nantes Cedex 1, , France
Centre Catherine de Sienne, Nantes, , France
Clinique de l'Archet, NICE Cedex 3, , France
CHU Car茅meau, NIMES Cedex 9, , France
CH La Source, Orleans Cedex 2, , France
H么pital Saint Louis, PARIS Cedex 10, , France
CHU H么pital Saint Antoine, PARIS Cedex 12, , France
H么pital Cochin, Paris, , France
H么pital Necker, Paris, , France
Institut Curie, Paris, , France
La Piti茅, Paris, , France
Centre Hospitalier de Perigueux, Perigueux, , France
CH Saint Jean, Perpignan, , France
CHRU - H么pital du Haut L茅v锚que - Centre Fran莽ois Magendie, Pessac, , France
Centre Hospitalier Lyon Sud, PIERRE-BENITE Cedex, , France
CHU Poitiers - P么le r茅gional de Canc茅rologie, Poitiers, , France
Ch Annecy Genevois, PRINGY Cedex, , France
H么pital Robert Debr茅, REIMS Cedex, , France
CHRU H么pital de Pontchaillou, RENNES Cedex 9, , France
Centre Henri Becquerel, ROUEN Cedex 1, , France
Institut de Canc茅rologie Lucien Neuwirth, Saint Priest-en-jarez, , France
Centre Hospitalier, SAINT QUENTIN Cedex, , France
Centre Hospitalier Yves Le Foll, Saint-brieuc, , France
CHU Strasbourg, Strasbourg, , France
Strasbourg Oncologie M茅dicale, Strasbourg, , France
P么le IUCT Oncopole CHU, TOULOUSE Cedex 9, , France
CHRU H么pital Bretonneau, TOURS Cedex, , France
CHRU H么pitaux de Brabois, VANDOEUVRE LES NANCY Cedex, , France
CHBA, VANNES Cedex, , 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
Haga zkh, Den Haag, , 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
Elisabeth zkh, Tilburg, , Netherlands
UMCU, Utrecht, , Netherlands
Isala Klinieken, Zwolle, , Netherlands
Contact Details
Name: Philippe Moreau, Pr
Affiliation: CHU Nantes, France
Role: PRINCIPAL_INVESTIGATOR
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