Spots Global Cancer Trial Database for Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
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Trial Identification
Brief Title: Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
Official Title: A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Study ID: NCT00910897
Conditions
Study Description
Brief Summary: Primary objective: * Compare the complete remission (CR) rates (i.e., the true CR, with negative immunofixation) achieved with either four courses of VD or four courses of VTD. Secondary objectives: * Compare the following parameters following 4 cycles of VD or VTD induction treatment: * CR rate+ very good partial remission (VGPR) rate * Overall remission rate (CR + VGPR + partial remission (PR) rate) * K/l light chain ratio in patients in CR. * Safety (quality of the sampled stem cells, extrahaematological and haematological toxicity: specially neurological toxicity, length of hospitalization). * Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell transplantation (ASCT).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ANVERS Centrumziekenhuis, Anvers, , Belgium
Anvers Uza, Anvers, , Belgium
Bruxelles Erasme, Bruxelles, , Belgium
Bruxelles I Bordet, Bruxelles, , Belgium
BRUXELLES St LUC, Bruxelles, , Belgium
GILLY, Gilly, , Belgium
YVOIR MontGodinne, Yvoir, , Belgium
Chu Angers, Angers, , France
CH Annecy, Annecy, , France
Ch Avignon, Avignon, , France
CH Bayonne, Bayonne, , France
Chu Besancon, Besancon, , France
CH BLOIS, Blois, , France
Bobigny Avicenne, Bobigny, , France
Chu Bordeaux, Bordeaux, , France
Chu Brest, Brest, , France
Caen M Interne Baclèse, Caen, , France
CH Chartres, Chartres, , France
Clamart Percy, Clamart, , France
CHU Clermont Ferrand, Clermont Ferrand, , France
Ch Colmar, Colmar, , France
Chu Dijon, Dijon, , France
Ch Dunkerque, Dunkerque, , France
Chu Grenoble, Grenoble, , France
CH La Roche Sur Yon, La Roche Sur Yon, , France
Le Mans Victor Hugo, Le Mans, , France
Chru Lille, Lille, , France
Ch Lorient, Lorient, , France
CHU Lyon Edouard Herriot, Lyon, , France
CHU Lyon Sud Pierre Benite, Lyon, , France
Lyon Léon Berard, Lyon, , France
Marseille IPC, Marseille, , France
CHR Metz Bonsecours, Metz, , France
Chu Nancy, Nancy, , France
Chu Nantes, Nantes, , France
Nantes Catherine De Sienne, Nantes, , France
CHU Nice M Interne, Nice, , France
CHR Orléans, Orleans, , France
Paris Cochin, Paris, , France
Paris Hôtel Dieu, Paris, , France
Paris Necker, Paris, , France
Paris St Antoine, Paris, , France
Paris St Louis, Paris, , France
CHU Poitiers hemato, Poitiers, , France
CHU Reims, Reims, , France
CHU Rennes Hemato, Rennes, , France
CHU Rennes M interne, Rennes, , France
CH Roanne, Roanne, , France
Rouen Becquerel, Rouen, , France
CH St Brieuc, St Brieuc, , France
St ETIENNE, St ETIENNE, , France
CHRU Strasbourg, Strasbourg, , France
Chu Toulouse, Toulouse, , France
CHU Tours, Tours, , France
CH Valence, Valence, , France
CH Vannes, Vannes, , France
Contact Details
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