Clinical trial NCT00910897: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Newly Diagnosed
multiple myeloma
induction
Thalidomide
Lead sponsor: Intergroupe Francophone du Myelome
Sponsor class: NETWORK
First posted: 2009-06-01
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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
* 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Anvers
country: Belgium
facility: ANVERS Centrumziekenhuis
city: Anvers
country: Belgium
facility: Anvers Uza
city: Bruxelles
country: Belgium
facility: Bruxelles Erasme
city: Bruxelles
country: Belgium
facility: Bruxelles I Bordet
city: Bruxelles
country: Belgium
facility: BRUXELLES St LUC
city: Gilly
country: Belgium
facility: GILLY
city: Yvoir
country: Belgium
facility: YVOIR MontGodinne
city: Angers
country: France
facility: Chu Angers
city: Annecy
country: France
facility: CH Annecy
city: Avignon
country: France
facility: Ch Avignon
city: Bayonne
country: France
facility: CH Bayonne
city: Besancon
country: France
facility: Chu Besancon
city: Blois
country: France
facility: CH BLOIS
city: Bobigny
country: France
facility: Bobigny Avicenne
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Brest
country: France
facility: Chu Brest
city: Caen
country: France
facility: Caen M Interne Baclèse
city: Chartres
country: France
facility: CH Chartres
city: Clamart
country: France
facility: Clamart Percy
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Colmar
country: France
facility: Ch Colmar
city: Dijon
country: France
facility: Chu Dijon
city: Dunkerque
country: France
facility: Ch Dunkerque
city: Grenoble
country: France
facility: Chu Grenoble
city: La Roche Sur Yon
country: France
facility: CH La Roche Sur Yon
city: Le Mans
country: France
facility: Le Mans Victor Hugo
city: Lille
country: France
facility: Chru Lille
city: Lorient
country: France
facility: Ch Lorient
city: Lyon
country: France
facility: CHU Lyon Edouard Herriot
city: Lyon
country: France
facility: CHU Lyon Sud Pierre Benite
city: Lyon
country: France
facility: Lyon Léon Berard
city: Marseille
country: France
facility: Marseille IPC
city: Metz
country: France
facility: CHR Metz Bonsecours
city: Nancy
country: France
facility: Chu Nancy
city: Nantes
country: France
facility: Chu Nantes
city: Nantes
country: France
facility: Nantes Catherine De Sienne
city: Nice
country: France
facility: CHU Nice M Interne
city: Orleans
country: France
facility: CHR Orléans
city: Paris
country: France
facility: Paris Cochin
city: Paris
country: France
facility: Paris Hôtel Dieu
city: Paris
country: France
facility: Paris Necker
city: Paris
country: France
facility: Paris St Antoine
city: Paris
country: France
facility: Paris St Louis
city: Poitiers
country: France
facility: CHU Poitiers hemato
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: CHU Rennes Hemato
city: Rennes
country: France
facility: CHU Rennes M interne
city: Roanne
country: France
facility: CH Roanne
city: Rouen
country: France
facility: Rouen Becquerel
city: St Brieuc
country: France
facility: CH St Brieuc
city: St ETIENNE
country: France
facility: St ETIENNE
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
city: Tours
country: France
facility: CHU Tours
city: Valence
country: France
facility: CH Valence
city: Vannes
country: France
facility: CH Vannes
Study officials:
References:
citation: Moreau P, Avet-Loiseau H, Facon T, Attal M, Tiab M, Hulin C, Doyen C, Garderet L, Randriamalala E, Araujo C, Lepeu G, Marit G, Caillot D, Escoffre M, Lioure B, Benboubker L, Pegourie B, Kolb B, Stoppa AM, Fuzibet JG, Decaux O, Dib M, Berthou C, Chaleteix C, Sebban C, Traulle C, Fontan J, Wetterwald M, Lenain P, Mathiot C, Harousseau JL. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011 Nov 24;118(22):5752-8; quiz 5982. doi: 10.1182/blood-2011-05-355081. Epub 2011 Aug 17.