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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00910897
• Other study ID #: IFM 2007-02
• Secondary ID: Eudract 2007-005
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 29, 2009
• Last updated: May 29, 2009
• Start date: March 2008

Study information

• Verified date: May 2009
• Source: Intergroupe Francophone du Myelome
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 205
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

• 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Velcade-Dexamethasone

• Velcade-Thalidomide-Dexamethasone

Locations

Country	Name	City	State
Belgium	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
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone du Myelome

Countries where clinical trial is conducted

Belgium,  France,