Spots Global Cancer Trial Database for Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
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Trial Identification
Brief Title: Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
Official Title: Randomized Study Comparing Conventional Dose Treatment Using a Combination of Lenalidomide, Bortezomib and Dexamethasone to High-Dose Treatment With ASCT in the Initial Management of Myeloma in Patients up to 65 Years of Age
Study ID: NCT01191060
Conditions
Study Description
Brief Summary: Objective of this study is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs Progression-free survival (by at least 9 months).
Detailed Description: Study design Phase III, multicenter, randomized, open-label study designed to evaluate the clinical benefit from the drug combination RVD without immediate high-dose therapy (HDT) followed by lenalidomide maintenance (Arm A) versus RVD plus HDT and PBSCT followed by lenalidomide maintenance (Arm B).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CH du Pays D'Aix, Aix-en-provence, , France
CHRU - Hôpital Sud Amiens, AMIENS cedex 1, , France
CHU d'Angers, ANGERS cedex 01, , France
Centre Hospitalier Argenteuil Victor Dupouy, Argenteuil, , France
Centre Hospitalier H.Duffaut, Avignon, , France
Centre Hospitalier de la côte basque, Bayonne, , France
Hôpital Jean Minjoz, Besançon, , France
Centre Hospitalier de Blois, Blois, , France
Hôpital Avicenne, Bobigny, , France
Polyclinique Bordeaux Nord Aquitaine, Bordeaux, , France
Hôpital A.Morvan, Brest, , France
CHU Caen Côte de Nacre, Caen, , France
Centre François Baclesse, Caen, , France
CH René Dubos, Cergy-Pontoise, , France
Centre Hospitalier William Morey, Chalon-sur-saone, , France
CH Chambéry, Chambéry, , France
Hôpital Antoine Béclère, Clamart cedex, , France
Hôpital d'instruction des armées Percy, Clamart cedex, , France
Pole Santé République, Clermont - Ferrand, , France
CHU d'Estaing, Clermont-Ferrand, , France
CH Louis Pasteur - Colmar, Colmar, , France
CH Sud Francilien, Corbeil-Essonnes, , France
CHU Henri Mondor, Créteil, , France
CHRU Dijon, Dijon, , France
Centre Hospitalier Général - Dunkerque, Dunkerque, , France
Hôpital A.Michallon, Grenoble, , France
Centre hospitalier départemental - La Roche sur Yon cedex, La Roche sur Yon cedex, , France
CH de Chartres - Hôpital Louis Pasteur, Le Coudray, , France
Centre Jean Bernard, Le Mans, , France
Centre hospitalier Le Mans, Le Mans, , France
CHRU - Hôpital Claude Huriez, Lille, , France
CHU de Limoges, Limoges, , France
Centre hospitalier Bodelio, Lorient, , France
CHU - Hôpital Edouard Herriot, Lyon, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
CH Meaux, Meaux, , France
Hopital E Muller, Mulhouse, , France
Hôpitaux de Brabois, Nancy, , France
Centre Catherine de Sienne, Nantes, , France
CHRU - Hôtel Dieu, Nantes, , France
Hôpital Archet 1, NICE cedex 3, , France
Hôpital de l'Archet, Nice cedex 3, , France
Groupe Hospitalo-Universitaire Carémeau, Nîmes Cédex 9, , France
Hôpital Saint-Louis, PARIS cedex 10, , France
Hôpital St-Antoine, Paris cedex 12, , France
Institut Curie, Paris, , France
Hôpital Cochin, Paris, , France
CH Saint Jean, Perpignan, , France
CHRU - Hôpital du Haut Lévêque, Pessac, , France
Centre Hospitalier Lyon sud, Pierre - Bénite cedex, , France
CHRU - Hôpital Jean Bernard, Poitiers, , France
Centre Hospitalier de la région d'Annecy, Pringy, , France
Hôpital R.Debré, Reims, , France
CHRU - Hôpital de Pontchaillou, Rennes, , France
CHRU - Hôpital Sud, Rennes, , France
Centre Henri Becquerel, Rouen, , France
Groupe Hospitalier Sud Réunion, SAINT-PIERRE cedex, , France
Centre René Huguenin, St Cloud, , France
Centre Hospitalier Yves le Foll, St-Brieuc cedex 1, , France
Centre Hospitalier Départemental - La réunion St Denis, St-denis, , France
Institut de Cancérologie de la Loire, St-priest-en-jarez, , France
Hôpitaux Universitaires de Strasbourg, Strasbourg, , France
University Hospital of Toulouse, Purpan, Toulouse, , France
CHRU - Hôpital Bretonneau, Tours, , France
Centre Hospitalier de Valence, Valence, , France
CH Bretagne Atlantique Vannes et Auray, Vannes cedex, , France
Institut Gustave Roussy, Villejuif cedex, , France
Contact Details
Name: MICHEL ATTAL, MD PhD
Affiliation: University Hospital of Toulouse
Role: PRINCIPAL_INVESTIGATOR
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