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Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)
Sponsor: Nantes University Hospital
Summary
This is a phase III, multicenter, prospective with a clinical benefit, open-label and randomized study to compare two different treatments : Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) versus Velcade (Bortezomib) Cyclophosphamide Dexamethasone (VCD) as an Induction Treatment prior to Autologous Stem Cell Transplantation in patients with Newly Diagnosed Multiple Myeloma. Eligible patients will be randomized into 2 treatment arms. Each patient will receive 4 consecutive 21 day cycles of an induction treatment with either VTD or VCD.
Official title: A PHASE III STUDY OF VELCADE (BORTEZOMIB) THALIDOMIDE DEXAMETHASONE (VTD) VERSUS VELCADE (BORTEZOMIB) CYCLOPHOSPHAMIDE DEXAMETHASONE (VCD) AS AN INDUCTION TREATMENT PRIOR TO AUTOLOGOUS STEM CELL TRANSPLANTATION IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA."
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
358
Start Date
2013-10
Completion Date
2015-08
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Thalidomide®
Cyclophosphamide
Velcade®
Dexaméthasone
Locations (62)
Centre Hospitalier de la région d'Annecy
Annecy, Pringy, France
CHRU Hôpital Sud
Amiens, France
CHU Angers
Angers, France
Centre Hospitalier Argenteuil
Argenteuil, France
Centre Hospitalier H.Duffaut
Avignon, France
Centre Hospitalier de la Côte Basque
Bayonne, France
CHRU de Besançon
Besançon, France
Hôpital Avicenne
Bobigny, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre hospitalier Pierre Oudot
Bourgoin, France
Hôpital A.Morvan
Brest, France
CHU Caen Côte de Nacre
Caen, France
CH René Dubos
Cergy-Pontoise, France
Centre Hospitalier William Morey
Chalon/saone, France
Hôpital d'instruction des armées Percy
Clamart, France
CHU d'Estaing
Clermont-Ferrand, France
Hôpitaux civils de Colmar
Colmar, France
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France
CHU Henri Mondor
Créteil, France
CHRU Dijon
Dijon, France
Centre Hospitalier Général
Dunkirk, France
CHRU - Hôpital A.Michallon
Grenoble, France
Centre hospitalier départemental Vendée
La Roche-sur-Yon, France
Hôpital Louis Pasteur
Le Coudray, France
Centre Jean Bernard
Le Mans, France
CH Le Mans
Le Mans, France
Hopital Saint Vincent de Paul
Lille, France
CHRU - Hôpital Claude Huriez
Lille, France
CHU de Limoges
Limoges, France
Hôpital Du Scorff
Lorient, France
Centre Léon Bérard
Lyon, France
Institut Paoli Calmettes
Marseille, France
Centre Hospitalier de Meaux
Meaux, France
CHR Metz Thionville
Metz, France
Centre Hospitalier intercommunale Meulan les mureaux
Meulan-en-Yvelines, France
Hopital E Muller
Mulhouse, France
Nantes University Hospital
Nantes, France
Hôpital de l'Archet 1
Nice, France
Groupe Hospitalo-Universitaire Carémeau
Nîmes, France
Institut CURIE
Paris, France
Hôpital Cochin
Paris, France
CHU - Hôpital St-Antoine
Paris, France
Hôpital Pitié-Salpétrière
Paris, France
AP-HP Hôpital Necker
Paris, France
CH Saint Jean
Perpignan, France
CHRU - Hôpital du Haut Lévêque
Pessac, France
Centre Hospitalier de PERIGUEUX
Périgueux, France
Centre Hospitalier Lyon sud
Pierre-Bénite, France
CHRU - Hôpital Jean Bernard
Poitiers, France
Hôpital R.Debré
Reims, France
CHRU - Hôpital de Pontchaillou
Rennes, France
Centre Henri Becquerel
Rouen, France
Centre Hospitalier Yves le Foll
Saint-Brieuc, France
Centre René Huguenin
Saint-Cloud, France
Institut de Cancérologie de la Loire
Saint-Priest-en-Jarez, France
Centre Hospitalier
Saint-Quentin, France
Centre hospitalier
St-Malo, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
CHRU - Hôpital Purpan
Toulouse, France
CHRU - Hôpital Bretonneau
Tours, France
CHRU - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
CH Bretagne Atlantique Vannes et Auray
Vannes, France