Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Velcade-Dexamethasone
|
Drug: Velcade-Dexamethasone
|
| Active Comparator: Velcade-Thalidomide-Dexamethasone
|
Drug: Velcade-Thalidomide-Dexamethasone
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
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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
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Use of any investigational drug in the 30 days preceding randomization
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ANVERS Centrumziekenhuis | Anvers | Belgium | ||
| 2 | Anvers Uza | Anvers | Belgium | ||
| 3 | Bruxelles Erasme | Bruxelles | Belgium | ||
| 4 | Bruxelles I Bordet | Bruxelles | Belgium | ||
| 5 | BRUXELLES St LUC | Bruxelles | Belgium | ||
| 6 | GILLY | Gilly | Belgium | ||
| 7 | YVOIR MontGodinne | Yvoir | Belgium | ||
| 8 | Chu Angers | Angers | France | ||
| 9 | CH Annecy | Annecy | France | ||
| 10 | Ch Avignon | Avignon | France | ||
| 11 | CH Bayonne | Bayonne | France | ||
| 12 | Chu Besancon | Besancon | France | ||
| 13 | CH BLOIS | Blois | France | ||
| 14 | Bobigny Avicenne | Bobigny | France | ||
| 15 | Chu Bordeaux | Bordeaux | France | ||
| 16 | Chu Brest | Brest | France | ||
| 17 | Caen M Interne Baclèse | Caen | France | ||
| 18 | CH Chartres | Chartres | France | ||
| 19 | Clamart Percy | Clamart | France | ||
| 20 | CHU Clermont Ferrand | Clermont Ferrand | France | ||
| 21 | Ch Colmar | Colmar | France | ||
| 22 | Chu Dijon | Dijon | France | ||
| 23 | Ch Dunkerque | Dunkerque | France | ||
| 24 | Chu Grenoble | Grenoble | France | ||
| 25 | CH La Roche Sur Yon | La Roche Sur Yon | France | ||
| 26 | Le Mans Victor Hugo | Le Mans | France | ||
| 27 | Chru Lille | Lille | France | ||
| 28 | Ch Lorient | Lorient | France | ||
| 29 | CHU Lyon Edouard Herriot | Lyon | France | ||
| 30 | CHU Lyon Sud Pierre Benite | Lyon | France | ||
| 31 | Lyon Léon Berard | Lyon | France | ||
| 32 | Marseille IPC | Marseille | France | ||
| 33 | CHR Metz Bonsecours | Metz | France | ||
| 34 | Chu Nancy | Nancy | France | ||
| 35 | Chu Nantes | Nantes | France | ||
| 36 | Nantes Catherine De Sienne | Nantes | France | ||
| 37 | CHU Nice M Interne | Nice | France | ||
| 38 | CHR Orléans | Orleans | France | ||
| 39 | Paris Cochin | Paris | France | ||
| 40 | Paris Hôtel Dieu | Paris | France | ||
| 41 | Paris Necker | Paris | France | ||
| 42 | Paris St Antoine | Paris | France | ||
| 43 | Paris St Louis | Paris | France | ||
| 44 | CHU Poitiers hemato | Poitiers | France | ||
| 45 | CHU Reims | Reims | France | ||
| 46 | CHU Rennes Hemato | Rennes | France | ||
| 47 | CHU Rennes M interne | Rennes | France | ||
| 48 | CH Roanne | Roanne | France | ||
| 49 | Rouen Becquerel | Rouen | France | ||
| 50 | CH St Brieuc | St Brieuc | France | ||
| 51 | St ETIENNE | St ETIENNE | France | ||
| 52 | CHRU Strasbourg | Strasbourg | France | ||
| 53 | Chu Toulouse | Toulouse | France | ||
| 54 | CHU Tours | Tours | France | ||
| 55 | CH Valence | Valence | France | ||
| 56 | CH Vannes | Vannes | France |
Sponsors and Collaborators
- Intergroupe Francophone du Myelome
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IFM 2007-02
- Eudract 2007-005204-40