Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
- Conditions
- Myeloma
- Interventions
- Drug: Lenalidomide, Bortezomib
- Registration Number
- NCT01191060
- Lead Sponsor
- University Hospital, Toulouse
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 700
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lenalidomide, bortezomib with ASCT Lenalidomide, Bortezomib RVD q 21 days (2 cycles) Collection of peripheral blood stem cells (PBSCs) using cyclophosphamide and GCSF (type Granocyte® or equivalent) Autologous stem cell transplant: Melphalan: infused over two days (day -2 and day -1) or as a single infusion (day-2) according to institutional practice Re-infusion of PBSCs RVD q 21 days (2 cycles) Maintenance Lenalidomide q28 days (12 months) lenalidomide, bortezomib without ASCT Lenalidomide, Bortezomib RVD q 21 days (2 cycles) Collection of peripheral blood stem cells (PBSCs) using cyclophosphamide and GCSF (type Granocyte® or equivalent) RVD q 21 days (5 cycles) Maintenance Lenalidomide q28 days (12 months)
- Primary Outcome Measures
Name Time Method Progression Free Survival up to 4 years To compare progression-free survival (PFS) between the Arm A and Arm B up to 4 years or until progression
- Secondary Outcome Measures
Name Time Method Genetic prognostic groups definition up to 4 years Genetic prognostic groups definition (evaluated by gene expression profiling-GEP) from randomization up to 4 years or until progression
Best treatment examination in each GEP-defined prognostic group. up to 4 years Best treatment examination in each GEP-defined prognostic group. from randomization up to 4 years or until progression
Response Rates up to 4 years -Response rates (RR) between the two arms up to 4 years or until progression
Time To Progression up to 4 years Time to progression (TTP) between the two arms up to 4 years or until progression
Toxicity comparison up to 4 years Toxicity comparison between the two arms randomization up to 4 years or until progression
Trial Locations
- Locations (68)
Centre Hospitalier Argenteuil Victor Dupouy
🇫🇷Argenteuil, France
Hôpital d'instruction des armées Percy
🇫🇷Clamart cedex, France
Hôpital de l'Archet
🇫🇷Nice cedex 3, France
Centre Catherine de Sienne
🇫🇷Nantes, France
CHRU - Hôtel Dieu
🇫🇷Nantes, France
Hôpital St-Antoine
🇫🇷Paris cedex 12, France
Hôpital Cochin
🇫🇷Paris, France
Centre Hospitalier de Valence
🇫🇷Valence, France
Centre René Huguenin
🇫🇷St Cloud, France
Hôpital Jean Minjoz
🇫🇷Besançon, France
CHU d'Angers
🇫🇷ANGERS cedex 01, France
Hôpital A.Morvan
🇫🇷Brest, France
CHRU - Hôpital Sud Amiens
🇫🇷AMIENS cedex 1, France
Centre Hospitalier de Blois
🇫🇷Blois, France
CH Sud Francilien
🇫🇷Corbeil-Essonnes, France
CH Meaux
🇫🇷Meaux, France
CHU Caen Côte de Nacre
🇫🇷Caen, France
Pole Santé République
🇫🇷Clermont - Ferrand, France
CHU d'Estaing
🇫🇷Clermont-Ferrand, France
Centre Hospitalier H.Duffaut
🇫🇷Avignon, France
Centre Hospitalier de la côte basque
🇫🇷Bayonne, France
Centre hospitalier départemental - La Roche sur Yon cedex
🇫🇷La Roche sur Yon cedex, France
Centre Léon Bérard
🇫🇷Lyon, France
CH de Chartres - Hôpital Louis Pasteur
🇫🇷Le Coudray, France
CHRU - Hôpital Claude Huriez
🇫🇷Lille, France
Centre hospitalier Bodelio
🇫🇷Lorient, France
CHU de Limoges
🇫🇷Limoges, France
Institut Curie
🇫🇷Paris, France
CHRU - Hôpital Sud
🇫🇷Rennes, France
Centre Hospitalier Yves le Foll
🇫🇷St-Brieuc cedex 1, France
Centre Hospitalier Départemental - La réunion St Denis
🇫🇷St-denis, France
Centre Hospitalier Lyon sud
🇫🇷Pierre - Bénite cedex, France
Institut de Cancérologie de la Loire
🇫🇷St-priest-en-jarez, France
Centre Hospitalier de la région d'Annecy
🇫🇷Pringy, France
Centre Henri Becquerel
🇫🇷Rouen, France
CHRU - Hôpital du Haut Lévêque
🇫🇷Pessac, France
Hôpital Archet 1
🇫🇷NICE cedex 3, France
CH Saint Jean
🇫🇷Perpignan, France
Hôpital R.Debré
🇫🇷Reims, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
CHRU - Hôpital Bretonneau
🇫🇷Tours, France
University Hospital of Toulouse, Purpan
🇫🇷Toulouse, France
Centre François Baclesse
🇫🇷Caen, France
Institut Paoli Calmettes
🇫🇷Marseille, France
CH René Dubos
🇫🇷Cergy-Pontoise, France
Hôpital Antoine Béclère
🇫🇷Clamart cedex, France
CHU Henri Mondor
🇫🇷Créteil, France
CH Chambéry
🇫🇷Chambéry, France
CHU - Hôpital Edouard Herriot
🇫🇷Lyon, France
Hôpital Avicenne
🇫🇷Bobigny, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
CH du Pays D'Aix
🇫🇷Aix-en-provence, France
Centre Hospitalier William Morey
🇫🇷Chalon-sur-saone, France
Centre hospitalier Le Mans
🇫🇷Le Mans, France
Centre Jean Bernard
🇫🇷Le Mans, France
Hopital E Muller
🇫🇷Mulhouse, France
Groupe Hospitalo-Universitaire Carémeau
🇫🇷Nîmes Cédex 9, France
Hôpital Saint-Louis
🇫🇷PARIS cedex 10, France
CHRU - Hôpital Jean Bernard
🇫🇷Poitiers, France
CHRU - Hôpital de Pontchaillou
🇫🇷Rennes, France
CH Bretagne Atlantique Vannes et Auray
🇫🇷Vannes cedex, France
Groupe Hospitalier Sud Réunion
🇫🇷SAINT-PIERRE cedex, France
Institut Gustave Roussy
🇫🇷Villejuif cedex, France
CH Louis Pasteur - Colmar
🇫🇷Colmar, France
CHRU Dijon
🇫🇷Dijon, France
Centre Hospitalier Général - Dunkerque
🇫🇷Dunkerque, France
Hôpital A.Michallon
🇫🇷Grenoble, France
Hôpitaux de Brabois
🇫🇷Nancy, France