Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

Phase 3

• Conditions: Multiple Myeloma
• Interventions: Drug: Velcade-Dexamethasone; Drug: 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

Study Timeline

• Study Start: 2008-03
• Status Verified: 2009-05
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Last Update Submitted: 2009-05-29
• Study First Posted: 2009-06-01
• Last Update Posted: 2009-06-01
• Primary Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 205

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

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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

• 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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Velcade-Dexamethasone	Velcade-Dexamethasone	-
Velcade-Thalidomide-Dexamethasone	Velcade-Thalidomide-Dexamethasone	-

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