Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
- Conditions
- Multiple Myeloma
- Interventions
- Drug: Velcade-DexamethasoneDrug: Velcade-Thalidomide-Dexamethasone
- Registration Number
- NCT00910897
- Lead Sponsor
- Intergroupe Francophone du Myelome
- 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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 205
- Newly diagnosed symptomatic multiple myeloma (MM) patient
- Aged under 65
- Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
- Using effective contraceptive methods (for fertile men, women of childbearing potential)
- Provision of informed consent
- No evidence of active infection
-
Asymptomatic MM
-
Non-secretory MM
-
Aged 66 years or over
-
ECOG performance status over 2 (see Appendix 2)
-
Proven amyloidosis
-
A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
-
Positive HIV serology
-
A personal medical history of severe psychiatric disease
-
Severe diabetes contraindicating the use of high-dose dexamethasone
-
NCI grade ³ 2 peripheral neuropathy
-
Serum clinical chemistry:
- creatinine level > 300 µmol/L or requiring dialysis
- bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL)
-
Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
-
Radiation therapy in the 2 weeks preceding randomization
-
A personal medical history of allergic reactions to compounds containing boron or mannitol
-
Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure
-
Use of any investigational drug in the 30 days preceding randomization
-
Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
-
Severe pulmonary troubles (including acute infiltrative pneumopathy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Velcade-Dexamethasone Velcade-Dexamethasone - Velcade-Thalidomide-Dexamethasone Velcade-Thalidomide-Dexamethasone -
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (56)
Ch Avignon
🇫🇷Avignon, France
CH La Roche Sur Yon
🇫🇷La Roche Sur Yon, France
Ch Lorient
🇫🇷Lorient, France
CHU Lyon Sud Pierre Benite
🇫🇷Lyon, France
Chu Angers
🇫🇷Angers, France
CH Annecy
🇫🇷Annecy, France
CH Bayonne
🇫🇷Bayonne, France
Chu Besancon
🇫🇷Besancon, France
CHU Clermont Ferrand
🇫🇷Clermont Ferrand, France
Chru Lille
🇫🇷Lille, France
YVOIR MontGodinne
🇧🇪Yvoir, Belgium
Chu Bordeaux
🇫🇷Bordeaux, France
Bobigny Avicenne
🇫🇷Bobigny, France
Clamart Percy
🇫🇷Clamart, France
Chu Grenoble
🇫🇷Grenoble, France
CH BLOIS
🇫🇷Blois, France
Chu Dijon
🇫🇷Dijon, France
Lyon Léon Berard
🇫🇷Lyon, France
Chu Nancy
🇫🇷Nancy, France
St ETIENNE
🇫🇷St ETIENNE, France
Chu Toulouse
🇫🇷Toulouse, France
Rouen Becquerel
🇫🇷Rouen, France
Ch Dunkerque
🇫🇷Dunkerque, France
Caen M Interne Baclèse
🇫🇷Caen, France
CH Chartres
🇫🇷Chartres, France
Ch Colmar
🇫🇷Colmar, France
CHU Lyon Edouard Herriot
🇫🇷Lyon, France
Le Mans Victor Hugo
🇫🇷Le Mans, France
CHU Rennes Hemato
🇫🇷Rennes, France
CHR Metz Bonsecours
🇫🇷Metz, France
Chu Nantes
🇫🇷Nantes, France
Nantes Catherine De Sienne
🇫🇷Nantes, France
Paris Hôtel Dieu
🇫🇷Paris, France
CHU Nice M Interne
🇫🇷Nice, France
Paris St Antoine
🇫🇷Paris, France
CHR Orléans
🇫🇷Orleans, France
Paris St Louis
🇫🇷Paris, France
Paris Cochin
🇫🇷Paris, France
CHU Poitiers hemato
🇫🇷Poitiers, France
CHU Reims
🇫🇷Reims, France
CHU Rennes M interne
🇫🇷Rennes, France
CH Roanne
🇫🇷Roanne, France
CH Valence
🇫🇷Valence, France
CH Vannes
🇫🇷Vannes, France
Bruxelles I Bordet
🇧🇪Bruxelles, Belgium
BRUXELLES St LUC
🇧🇪Bruxelles, Belgium
Marseille IPC
🇫🇷Marseille, France
Chu Brest
🇫🇷Brest, France
Paris Necker
🇫🇷Paris, France
CHRU Strasbourg
🇫🇷Strasbourg, France
CH St Brieuc
🇫🇷St Brieuc, France
CHU Tours
🇫🇷Tours, France
ANVERS Centrumziekenhuis
🇧🇪Anvers, Belgium
Anvers Uza
🇧🇪Anvers, Belgium
GILLY
🇧🇪Gilly, Belgium
Bruxelles Erasme
🇧🇪Bruxelles, Belgium