Spots Global Cancer Trial Database for Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)
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Trial Identification
Brief Title: Efficacy Study Comparing Velcade Dexamethasone Thalidomide Versus Velcade Cyclophosphamide Dexamethasone as Induction Treatment in the Initial Management of Multiple Myeloma (IFM2013-04)
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."
Study ID: NCT01971658
Conditions
Study Description
Brief 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.
Detailed Description: The patient population will consist of adult men and women who have a confirmed diagnosis of Multiple Myeloma and who meet eligibility criteria. They will be recruited from among the patients consulting in an investigating centre's haematology service for newly diagnosed, symptomatic, untreated multiple myeloma. in each treatment arm there will be : 1. Induction therapy : 4 cycles of VTD (21 days)or VCD 2. Systematic stem cell harvest after cycle 3
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Jallieu, , 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, Creteil, , France
CHRU Dijon, Dijon, , France
Centre Hospitalier Général, Dunkerque, , 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, , France
Hopital E Muller, Mulhouse, , France
Nantes University Hospital, Nantes, , France
Hôpital de l'Archet 1, Nice, , France
Groupe Hospitalo-Universitaire Carémeau, Nimes, , France
CHU - Hôpital St-Antoine, PARIS cedex 12, , 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
Centre Hospitalier de PERIGUEUX, Perigueux, , France
CH Saint Jean, Perpignan, , France
CHRU - Hôpital du Haut Lévêque, Pessac, , France
Centre Hospitalier Lyon sud, Pierre Benite, , 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, Saint Quentin, , France
Centre Hospitalier Yves le Foll, St Brieuc, , France
Centre René Huguenin, St Cloud, , France
Centre hospitalier, ST Malo, , France
Institut de Cancérologie de la Loire, St Priest-en-jarez, , France
Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
CHRU - Hôpital Purpan, Toulouse, , France
CHRU - Hôpital Bretonneau, Tours, , France
CHRU - Hôpitaux de Brabois, Vandoeuvre Les Nancy, , France
CH Bretagne Atlantique Vannes et Auray, Vannes, , France
Contact Details
Name: Philippe MOREAU
Affiliation: Nantes University Hospital
Role: PRINCIPAL_INVESTIGATOR
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