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COMPLETED
NCT01971658
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Thalidomide®

DRUG

Cyclophosphamide

DRUG

Velcade®

DRUG

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